
CHAPTER I
Article 1 
This Regulation lays down requirements for the design and manufacture of personal protective equipment (PPE) which is to be made available on the market, in order to ensure protection of the health and safety of users and establish rules  concerning  PPE in the  United Kingdom.
Article 2 

1. This Regulation applies to PPE.
2. This Regulation does not apply to PPE:
(a) specifically designed for use by the armed forces or in the maintenance of law and order;
(b) designed to be used for self-defence, with the exception of PPE intended for sporting activities;
(c) designed for private use to protect against:
((i)) atmospheric conditions that are not of an extreme nature,
((ii)) damp and water during dishwashing;
(d) for exclusive use on seagoing vessels or aircraft that are subject to the relevant international treaties applicable in  the United Kingdom;
(e) for head, face or eye protection of users, that is covered by Regulation No 22 of the United Nations Economic Commission for Europe on uniform provisions concerning the approval of protective helmets and their visors for drivers and passengers of motorcycles and mopeds.
Article 3 
For the purposes of this Regulation, the following definitions apply:

((1)) ‘personal protective equipment’ (PPE) means:

((a)) equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person's health or safety;
((b)) interchangeable components for equipment referred to in point (a) which are essential for its protective function;
((c)) connexion systems for equipment referred to in point (a) that are not held or worn by a person, that are designed to connect that equipment to an external device or to a reliable anchorage point, that are not designed to be permanently fixed and that do not require fastening works before use;
((2)) ‘making available on the market’ means any supply of PPE for distribution or use on the  market of Great Britain  in the course of a commercial activity, whether in return for payment or free of charge;
((3)) ‘placing on the market’ means the first making available of PPE on the  market of Great Britain;
((4)) ‘manufacturer’ means any natural or legal person who manufactures PPE or has it designed or manufactured, and markets it under his name or trademark;
((5)) ‘authorised representative’ means any natural or legal person established within the  United Kingdom  who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks;
((6)) importer” means a person who—
((a)) is established in the United Kingdom and places PPE from a country outside of the United Kingdom on the market; or
((b)) is established in Northern Ireland and places PPE on the market that has been supplied to them for distribution, consumption or use in the course of a commercial activity, whether in return for payment or free of charge, from an EEA state;
((7)) ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes PPE available on the market;
((8)) ‘economic operators’ means the manufacturer, the authorised representative, the importer and the distributor;
((9)) ‘technical specification’ means a document that prescribes technical requirements to be fulfilled by PPE;
((10)) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
((11)) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
((12)) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
((13)) ‘conformity assessment’ means the process demonstrating whether the essential health and safety requirements of this Regulation relating to PPE have been fulfilled;
((14)) ‘conformity assessment body’ means a body that performs conformity assessment activities including calibration, testing, certification and inspection;
((15)) ‘recall’ means any measure aimed at achieving the return of PPE that has already been made available to the end-user;
((16)) ‘withdrawal’ means any measure aimed at preventing PPE in the supply chain from being made available on the market;
((17)) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
((18)) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
((19)) ‘approved body’ has the meaning given in Article 20;
((20)) ‘designated standard’ has the meaning given in Article 7A;
((21)) ‘enforcement authority’ means a person enforcing this Regulation under regulation 4 of the Personal Protective Equipment (Enforcement) Regulations 2018 (S.I. 2018/390);
((22)) ‘UK Marking’ means the marking in the form set out in Annex 2 of Regulation (EC) 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products, and repealing Regulation (EEC) 339/93;
((23)) ‘UK national accreditation body’ means the body appointed by the Secretary of State in accordance with Article 4 of Regulation (EC) 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products, and repealing Regulation (EEC) 339/93;
((24)) ‘Regulation 2016/425 (pre-exit)’ means Regulation (EU) 2016/425 of the European Parliament and of the Council on personal protective equipment and repealing Council Directive 89/686/EEC, as it had effect immediately before  IP completion day;
((25)) In this Regulation, references to  “the market surveillance authority” are to be construed in accordance with regulation 3 of the Personal Protective Equipment (Enforcement) Regulations 2018.
Article 4 
PPE shall only be made available on the market if, where properly maintained and used for its intended purpose, it complies with this Regulation and does not endanger the health or safety of persons, domestic animals or property.
Article 5 
PPE shall meet the essential health and safety requirements set out in Annex II which apply to it.
Article 6 
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Article 7 

1. Nothing in this Regulation impedes, for the aspects covered by this Regulation, the making available on the market of PPE which complies with this Regulation.
2. At trade fairs, exhibitions and demonstrations or similar events,  nothing in this Regulation prevents  the showing of PPE which does not comply with this Regulation, provided that a visible sign clearly indicates that the PPE does not comply with this Regulation and is not available on the market until it has been brought into conformity.During demonstrations, adequate measures shall be taken to ensure the protection of persons.
Article 7A 

(1.) Subject to paragraphs 6 and 7, in this Regulation, a  “designated standard” means a technical specification which is—
(a) adopted by a recognised standardisation body or an international standardising body, for repeated or continuous application, with which compliance is not compulsory; and
(b) designated by the Secretary of State, by publishing the reference to the standard and maintaining that publication in a manner the Secretary of State considers appropriate.
(2.) For the purposes of paragraph 1,  “technical specification” means a document that prescribes technical requirements to be fulfilled by a product, process, service or system and which lays down one or more of the following—
(a) the characteristics required of a product, including—
(i) levels of quality, performance, interoperability, environmental protection, health, safety or dimensions; and
(ii) the requirements applicable to the product as regards the name under which the product is sold, terminology, symbols, testing and test methods, packaging, marking or labelling and conformity assessment procedures;
(b) production methods and processes relating to the product, where these have an effect on the characteristics of the product.
(3.) For the purposes of this Article, a  “recognised standardisation body” means any one of the following organisations—
(a) the European Committee for Standardisation (CEN);
(b) the European Committee for Electrotechnical Standardisation (Cenelec);
(c) the European Telecommunications Standards Institute (ETSI);
(d) the British Standards Institution (BSI).
(3A.) In this Article  “international standardising body” has the same meaning as it has for the purposes of the Agreement on Technical Barriers to Trade, part of Annex 1A to the agreement establishing the World Trade Organisation signed at Marrakesh on 15 April 1994 (as modified from time to time).
(4.) When considering whether the manner of publication of a reference is appropriate in accordance with paragraph 1(b), the Secretary of State must have regard to whether the publication will draw the standard to the attention of any person who may have an interest in the standard.
(5.) Before publishing the reference to a technical specification adopted by the British Standards Institution, the Secretary of State must have regard to whether the technical specification is consistent with  such technical specifications adopted by the other recognised standardisation bodies or by international standardising bodies as the Secretary of State considers to be relevant.
(6.) The Secretary of State may remove from publication the reference to a standard which has been published in accordance with paragraph 1(b).
(7.) Where the Secretary of State removes the reference to a standard from publication, that standard is no longer a designated standard.
(8.) In this Article, a reference to a  “product” is a reference to PPE to which this Regulation applies.
(9.) The Secretary of State may, by regulations, amend paragraph 3 to reflect any changes in the name or structure of the recognised standardisation bodies.
(10.) Regulations made under paragraph 9 must be made by statutory instrument, subject to annulment in pursuance of a resolution of either House of Parliament.
CHAPTER II
Article 8 

1. When placing PPE on the market, manufacturers shall ensure that it has been designed and manufactured in accordance with the applicable essential health and safety requirements set out in Annex II.
2. Manufacturers shall draw up the technical documentation referred to in Annex III (‘technical documentation’) and carry out the applicable conformity assessment procedure referred to in Article 19 or have it carried out.Where compliance of PPE with the applicable essential health and safety requirements has been demonstrated by the appropriate procedure, manufacturers shall draw up the ... declaration of conformity referred to in Article 15 and affix the  UK  marking referred to in Article 16.
3. Manufacturers shall keep the technical documentation and the ... declaration of conformity for 10 years after the PPE has been placed on the market.
4. Manufacturers shall ensure that procedures are in place for series production to remain in conformity with this Regulation. Changes in the design or characteristics of the PPE and changes in the  designated  standards or in other technical specifications by reference to which the conformity of the PPE is declared shall be adequately taken into account.When deemed appropriate with regard to the risks presented by PPE, manufacturers shall, to protect the health and safety of consumers and other end-users, carry out sample testing of PPE made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming PPE and PPE recalls, and shall keep distributors informed of any such monitoring.
5. Manufacturers shall ensure that the PPE which they place on the market bears a type, batch or serial number or other element allowing its identification, or, where the size or nature of the PPE does not allow it, that the required information is provided on the packaging or in a document accompanying the PPE.
6. Manufacturers shall indicate, on the PPE, their name, registered trade name or registered trade mark and the postal address at which they can be contacted or, where that is not possible, on its packaging or in a document accompanying the PPE. The address shall indicate a single point at which the manufacturer can be contacted. The contact details shall be in a language easily understood by end-users and  the market surveillance authority.
7. Manufacturers shall ensure that the PPE is accompanied by the instructions and information set out in point 1.4 of Annex II  and that they are clear, legible and in easily understandable English.
8. The manufacturer shall either provide the ... declaration of conformity with the PPE or include in the instructions and information set out in point 1.4 of Annex II the internet address at which the ... declaration of conformity can be accessed.
9. Manufacturers who consider or have reason to believe that PPE which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective measures necessary to bring that PPE into conformity, to withdraw it or to recall it, as appropriate. Furthermore, where the PPE presents a risk, manufacturers shall immediately inform  the enforcement authority  to that effect, giving details, in particular, of the non-conformity and of any corrective measures taken.
10. Manufacturers shall, further to a reasoned request from  the enforcement authority, provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the PPE with this Regulation, in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by PPE which they have placed on the market.
Article 9 

1. A manufacturer may, by a written mandate, appoint  a person established in the United Kingdom as their... authorised representative.The obligations laid down in Article 8(1) and the obligation to draw up the technical documentation referred to in Article 8(2) shall not form part of the authorised representative's mandate.
2. An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorised representative to do at least the following:
(a) keep the ... declaration of conformity and the technical documentation at the disposal of the ... market surveillance  authority  for 10 years after the PPE has been placed on the market;
(b) further to a reasoned request from  the enforcement authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of the PPE;
(c) cooperate with the  enforcement authority, at their request, on any action taken to eliminate the risks posed by PPE covered by the authorised representative's mandate.
Article 10 

1. Importers shall place only compliant PPE on the market.
2. Before placing PPE on the market, importers shall ensure that the appropriate conformity assessment procedure referred to in Article 19 has been carried out by the manufacturer. They shall ensure that the manufacturer has drawn up the technical documentation, that the PPE bears the  UK  marking and is accompanied by the required documents, and that the manufacturer has complied with the requirements set out in Article 8(5) and (6).Where an importer considers or has reason to believe that PPE is not in conformity with the applicable essential health and safety requirements set out in Annex II, he shall not place it on the market until it has been brought into conformity. Furthermore, where the PPE presents a risk, the importer shall inform the manufacturer and the market surveillance  authority  to that effect.
3. Importers shall indicate, on the PPE, their name, registered trade name or registered trade mark and the postal address at which they can be contacted .... The contact details shall be in a language easily understood by end-users and market surveillance  authority.The obligation set out in this paragraph 3 to indicate information on the PPE does not apply where— 
(a) either—
(i) it is not possible to indicate that information on the PPE, or
(ii) the importer has imported the PPE from an EEA state or Switzerland  and places it on the market within the period of   seven years   beginning with  IP completion day, and
(b) before placing the PPE on the market, the importer sets out the information referred to in this paragraph 3 on the packaging of the PPE or in a document accompanying the PPE.
4. Importers shall ensure that the PPE is accompanied by the instructions and information set out in point 1.4 of Annex II  and that they are clear, legible and in easily understandable English.
5. Importers shall ensure that, while the PPE is under their responsibility, storage or transport conditions do not jeopardise its conformity with the applicable essential health and safety requirements set out in Annex II.
6. When deemed appropriate with regard to the risks presented by PPE, importers shall, to protect the health and safety of consumers and other end-users, carry out sample testing of PPE made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming PPE and PPE recalls, and shall keep distributors informed of any such monitoring.
7. Importers who consider or have reason to believe that PPE which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective measures necessary to bring the PPE into conformity, to withdraw it or to recall it, as appropriate. Furthermore, where the PPE presents a risk, importers shall immediately inform the  enforcement authority  to that effect, giving details, in particular, of the non-conformity and of any corrective measures taken.
8. Importers shall, for 10 years after the PPE has been placed on the market, keep a copy of the ... declaration of conformity at the disposal of the market surveillance  authority  and ensure that the technical documentation can be made available to  that authority, upon request.
9. Importers shall, further to a reasoned request from  the enforcement authority, provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of PPE in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by PPE which they have placed on the market.
Article 11 

1. When making PPE available on the market, distributors shall act with due care in relation to the requirements of this Regulation.
2. Before making PPE available on the market, distributors shall verify that it bears the  UK  marking, is accompanied by the required documents and by the instructions and information set out in point 1.4 of Annex II  and that they are clear, legible and in easily understandable English  and that the manufacturer and the importer have complied with the requirements set out in Article 8(5) and (6) and Article 10(3) respectively.Where a distributor considers or has reason to believe that PPE is not in conformity with the applicable essential health and safety requirements set out in Annex II, he shall not make the PPE available on the market until it has been brought into conformity. Furthermore, where the PPE presents a risk, the distributor shall inform the manufacturer or the importer to that effect as well as the market surveillance  authority.
3. Distributors shall ensure that, while PPE is under their responsibility, its storage or transport conditions do not jeopardise its conformity with the applicable essential health and safety requirements set out in Annex II.
4. Distributors who consider or have reason to believe that PPE which they have made available on the market is not in conformity with this Regulation shall make sure that the corrective measures necessary to bring it into conformity, to withdraw it or to recall it, as appropriate, are taken. Furthermore, where the PPE presents a risk, distributors shall immediately inform the  enforcement authority  to that effect, giving details, in particular, of the non-conformity and of any corrective measures taken.
5. Distributors shall, further to a reasoned request from  the enforcement authority, provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the PPE. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by PPE which they have made available on the market.
Article 12 
An importer or distributor shall be considered a manufacturer for the purposes of this Regulation and he shall be subject to the obligations of the manufacturer set out in Article 8 where he places PPE on the market under his name or trademark or modifies PPE already placed on the market in such a way that compliance with this Regulation may be affected.
Article 13 
Economic operators shall, on request, identify the following to the market surveillance  authority:

((a)) any economic operator who has supplied them with PPE;
((b)) any economic operator to whom they have supplied PPE.
Economic operators shall be able to present the information referred to in the first paragraph for 10 years after they have been supplied with the PPE and for 10 years after they have supplied the PPE.
CHAPTER III
Article 14 

(1.) PPE which is in conformity with a designated standard or part thereof shall be presumed to be in conformity with the essential health and safety requirements set out in Annex II covered by that standard or part thereof.
(2.) The presumption in paragraph 1 is rebuttable.
Article 15 

1. The ... declaration of conformity shall state that the fulfilment of the applicable essential health and safety requirements set out in Annex II has been demonstrated.
2. The ... declaration of conformity shall have the model structure set out in Annex IX, shall contain the elements specified in the relevant modules set out in Annexes IV, VI, VII and VIII and shall be continuously updated. It shall be  in English.
3. Where PPE is subject to more than one enactment requiring a declaration of conformity, the manufacturer must draw up a single declaration of conformity which identifies each enactment by its title.
4. By drawing up the ... declaration of conformity, the manufacturer shall assume responsibility for the compliance of the PPE with the requirements laid down in this Regulation.
Article 16 
The   UK   marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.
Article 17 

(A1.)  Paragraph 1 is subject to paragraph 1A.
1. The  UK  marking shall be affixed visibly, legibly and indelibly to the PPE. Where that is not possible or not warranted on account of the nature of the PPE, it shall be affixed to the packaging and to the documents accompanying the PPE.
(1A.) For a period of   seven years   months beginning with IP completion day, paragraph 1 does not apply where the UK marking is affixed to—
(a) a label affixed to the PPE; or
(b) a document accompanying the PPE.
2. The UK marking shall be affixed before the PPE is placed on the market.
3. For category III PPE, the UK marking shall be followed by the identification number of the  approved  body involved in the procedure set out in Annex VII or VIII.The identification number of the approved body shall be affixed by the body itself or, under its instructions, by the manufacturer or his authorised representative.
4. The UK marking and, where applicable, the identification number of the  approved  body may be followed by a pictogram or other marking indicating the risk against which the PPE is intended to protect.
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CHAPTER IV
Article 18 
The PPE shall be classified according to the risk categories set out in Annex I.
Article 19 
The conformity assessment procedures to be followed for each of the risk categories set out in Annex I are as follows:

((a)) Category I: internal production control (module A) set out in Annex IV;
((b)) Category II: ... type-examination (module B) set out in Annex V, followed by conformity to type based on internal production control (module C) set out in Annex VI;
((c)) Category III: ... type-examination (module B) set out in Annex V, and either of the following:

((i)) conformity to type based on internal production control plus supervised product checks at random intervals (module C2) set out in Annex VII;
((ii)) conformity to type based on quality assurance of the production process (module D) set out in Annex VIII.
By way of derogation, for PPE produced as a single unit to fit an individual user and classified according to Category III, the procedure referred to in point (b) may be followed.
CHAPTER V
Article 20 

(1.) An approved body is a conformity assessment body which—
((a)) has been approved by the Secretary of State pursuant to the procedure set out in Article 21 (approval of conformity assessment bodies); or
((b)) immediately before  IP completion day  was a notified body in respect of which the Secretary of State had taken no action under Article 30 of Regulation 2016/425 (pre-exit), to suspend or withdraw the body's status as a notified body.
(2.) Paragraph 1 has effect subject to Article 30 (restriction, suspension or withdrawal of approval).
(3.) In this Chapter—
 “notified body” means a body which—
((a)) the Secretary of State had, before IP completion day, notified to the European Commission and the member States of the European Union in accordance with Article 20 of Regulation 2016/425 (pre-exit); and
((b)) in respect of which no objections had been raised, as referred to in Article 28(5) of Regulation 2016/425 (pre-exit);
 “approved body requirements” means the requirements set out in Article 24.
Article 21 

1. The Secretary of State may approve only those conformity assessment bodies that qualify for approval.
2. A conformity assessment body qualifies for approval if the first and second conditions below are met.
3. The first condition is that the conformity assessment body has applied to the Secretary of State to become an approved body and that application is accompanied by—
(a) a description of—
(i) the conformity assessment activities that the conformity assessment body intends to carry out;
(ii) the conformity assessment procedure in respect of which the conformity assessment body claims to be competent;
(iii) the category of PPE in respect of which the conformity assessment body claims to be competent; and
(b) either—
(i) an accreditation certificate; or
(ii) the documentary evidence necessary for the Secretary of State to verify, recognise and regularly monitor the conformity assessment body's compliance with the approved body requirements.
4. The second condition is that the Secretary of State is satisfied that the conformity assessment body meets the approved body requirements.
(5.) For the purposes of paragraph 4, the Secretary of State may accept an accreditation certificate provided in accordance with paragraph 3(b), as sufficient evidence that the conformity assessment body meets the approved body requirements.
(6.) When deciding whether to approve a conformity assessment body that qualifies for approval, the Secretary of State may—
(a) have regard to any other matter which appears to the Secretary of State to be relevant; and
(b) set conditions that the conformity assessment body must meet.
(7.) For the purposes of this Article,  “accreditation certificate” means a certificate issued by the UK national accreditation body, attesting that a conformity assessment body meets the approved body requirements.
Article 22 
The Secretary of State may authorise the UK national accreditation body to carry out the following activities on behalf of the Secretary of State—
(a) assessing whether a conformity assessment body meets the approved body requirements;
(b) monitoring approved bodies in accordance with Article 23; and
(c) compiling and maintaining the register of approved bodies, in accordance with Article 29.
Article 23 
The Secretary of State must monitor each approved body with a view to verifying that the body—
The Commission shall make that information publicly available.
(a) continues to meet—
(i) the approved body requirements; and
(ii) any conditions set by the Secretary of State under Article 21(6)(b); and
(b) carries out its functions in accordance with this Regulation.
Article 24 

1. For the purposes of  approval, a conformity assessment body shall meet the requirements laid down in paragraphs 2 to 11.
2. A conformity assessment body must have legal personality and must be established in—
(a) the United Kingdom; or
(b) the territory of a party to the CPTPP.
(2A) In paragraph (2) “the CPTPP” has the meaning set out in section 1 of the Trade (Comprehensive and Progressive Agreement for Trans-Pacific Partnership) Act 2024.
3. A conformity assessment body shall be a third-party body independent of the organisation or the PPE it assesses.A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of PPE which it assesses, may, on the condition that its independence and the absence of any conflict of interest are demonstrated, be considered such a body.
4. A conformity assessment body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, purchaser, owner, user or maintainer of the PPE which they assess, nor the representative of any of those parties. This does not preclude the use of assessed PPE that are necessary for the operations of the conformity assessment body or the use of such PPE for personal purposes.A conformity assessment body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture, marketing, use or maintenance of PPE, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are  approved. This shall in particular apply to consultancy services.Conformity assessment bodies shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities.
5. Conformity assessment bodies and their personnel shall carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their conformity assessment activities, especially as regards persons or groups of persons with an interest in the results of those activities.
6. A conformity assessment body shall be capable of carrying out all the conformity assessment tasks assigned to it by Annexes V, VII and VIII and in relation to which it has been  approved, whether those tasks are carried out by the conformity assessment body itself or on its behalf and under its responsibility.At all times and for each conformity assessment procedure and each kind of PPE for which it has been approved, a conformity assessment body shall have at its disposal the necessary:
(a) personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks;
(b) descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the ability of reproduction of those procedures. It shall have appropriate policies and procedures in place that distinguish between tasks it carries out as  an approved body  and other activities;
(c) procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the PPE technology in question and the mass or serial nature of the production process.A conformity assessment body shall have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities.
7. The personnel responsible for carrying out conformity assessment tasks shall have the following:
(a) sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been  approved;
(b) satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;
(c) appropriate knowledge and understanding of the essential health and safety requirements set out in Annex II, of the applicable  designated  standards, and of the relevant provisions of  this Regulation and any other relevant United Kingdom legislation;
(d) the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.
8. The impartiality of the conformity assessment bodies, their top level management and of the personnel responsible for carrying out the conformity assessment tasks shall be guaranteed.The remuneration of the top level management and personnel responsible for carrying out the conformity assessment tasks of a conformity assessment body shall not depend on the number of assessments carried out or on the results of those assessments.
9. Conformity assessment bodies shall take out liability insurance unless  the Secretary of State  is directly responsible for the conformity assessment.
10. The personnel of a conformity assessment body shall observe professional secrecy with regard to all information obtained in carrying out their tasks under Annexes V, VII and VIII or any provision of  United Kingdom  law giving effect to it, except in relation to the  enforcement authority. Proprietary rights shall be protected.
11. Conformity assessment bodies shall participate in, or ensure that their personnel responsible for carrying out the conformity assessment tasks are informed of, the relevant standardisation activities and the activities of  any approved  body coordination group established  by the Secretary of State  and shall apply as general guidance the administrative decisions and documents produced as a result of the work of that group.
Article 25 

(1.) Where a conformity assessment body demonstrates its conformity with the criteria laid down in a designated standard (or part of such a standard), the Secretary of State must presume that the conformity assessment body meets the approved body requirements covered by that standard (or the part of that standard).
(2.) The presumption in paragraph 1 is rebuttable.
Article 26 

1. An approved body may subcontract specific conformity assessment activities, or use a subsidiary to carry out such activities provided—
(a) the body is satisfied that the subcontractor or subsidiary meets the approved body requirements;
(b) the body has informed the Secretary of State that it is satisfied that the subcontractor or subsidiary meets those requirements; and
(c) the economic operator for whom the activities are to be carried out has consented to the activities being carried out by that person.
2. The approved body which subcontracts specific conformity assessment activities or uses a subsidiary to carry out such activities remains responsible for the proper performance of those activities (irrespective of where the subcontractor or subsidiary is established).
3. Where an approved body subcontracts, or uses a subsidiary to carry out, a specific conformity assessment activity, the approved body must, for a period of 10 years beginning on the day on which the activity is first carried out, keep available for inspection by the Secretary of State all relevant documentation concerning—
(a) the assessment of the qualifications of the subcontractor or the subsidiary; and
(b) the conformity assessment activity carried out by the subcontractor or subsidiary.
4. In this Article,  “subsidiary” has the meaning given to it by section 1159 of the Companies Act 2006.
Article 27 
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Article 28 
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Article 29 

1. The Secretary of State must—
(a) assign an approved body identification number to each approved body; and
(b) compile and maintain a register of—
(i) approved bodies;
(ii) their approved body identification numbers;
(iii) the activities for which they have been approved; and
(iv) any restrictions on those activities.
2. The register referred to in paragraph 1 must be made publicly available.
Article 30 

1. Where the Secretary of State determines that an approved body—
(a) no longer meets an approved body requirement, or
(b) is failing to fulfil its obligations under these Regulations, other than a condition referred to in Article 21(6)(b),
the Secretary of State must restrict, suspend or withdraw the body's status as an approved body under Article 21.
2. Where the Secretary of State determines that an approved body no longer meets a condition referred to in Article 21(6)(b), the Secretary of State may restrict, suspend or withdraw the body's status as an approved body under Article 21.
(3.) In deciding what action to take under paragraph 1 or 2, the Secretary of State must have regard to the seriousness of the non-compliance.
(4.) Before taking action under paragraph 1 or 2, the Secretary of State must—
(a) give notice in writing to the approved body of the proposed action and the reasons for it;
(b) give the approved body an opportunity to make representations to the Secretary of State regarding the proposed action within a reasonable period from the date of the notice; and
(c) consider any such representations made by the approved body.
(5.) Where the Secretary of State has taken action in respect of an approved body under paragraph 1 or 2, or where an approved body has ceased its activity, the approved body must, at the request of the Secretary of State—
(a) transfer its files relating to the activities it has undertaken as an approved body to another approved body or to the Secretary of State; or
(b) keep its files relating to the activities it has undertaken as an approved body available for inspection by the Secretary of State and market surveillance authority for a period of 10 years from the date they were created.
(6.) The activities undertaken as an approved body referred to in paragraph 5 include any activities that the body has undertaken as a notified body.
Article 31 
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Article 32 

1. Approved  bodies shall carry out conformity assessments in accordance with the conformity assessment procedures provided for in Annexes V, VII and VIII.
(1A.) Subject to the terms of its appointment an approved body must carry out the conformity assessment activities and procedures, in respect of which—
(a) the body's approval was given under Article 21; or
(b) the body's notification as a notified body was made.
2. Conformity assessments shall be carried out in a proportionate manner, avoiding unnecessary burdens for economic operators. Conformity assessment bodies shall perform their activities taking due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the PPE technology in question and the mass or serial nature of the production process.In so doing they shall nevertheless respect the degree of rigour and the level of protection required for the compliance of the PPE with the requirements of this Regulation.
3. Where  an approved  body finds that the essential health and safety requirements set out in Annex II or the corresponding  designated  standards or other technical specifications have not been met by a manufacturer, it shall require the manufacturer to take appropriate corrective measures and shall not issue a certificate or approval decision.
4. Where, in the course of the monitoring of conformity following the issue of a certificate or approval decision,  an approved  body finds that a PPE no longer complies, it shall require the manufacturer to take appropriate corrective measures and shall suspend or withdraw the certificate or the approval decision if necessary.
5. Where corrective measures are not taken or do not have the required effect, the  approved  body shall restrict, suspend or withdraw any certificates or approval decisions, as appropriate.
Article 33 
Approved  bodies shall ensure that a transparent and accessible appeal procedure against their decisions is available.
Article 34 

1. Approved  bodies shall inform the  Secretary of State  of the following:
(a) any refusal, restriction, suspension or withdrawal of a certificate or approval decision;
(b) any circumstances affecting the scope of or conditions for  their approval;
(c) any request for information which they have received from  the market surveillance authority  regarding conformity assessment activities;
(d) on request, conformity assessment activities performed within the scope of their  approval  and any other activity performed, including cross-border activities and subcontracting.
2. Approved  bodies shall provide  other approved bodies  under this Regulation carrying out similar conformity assessment activities covering the same kinds of PPE with relevant information on issues relating to negative and, on request, positive conformity assessment results.
Article 35 
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Article 36 
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CHAPTER VI
Article 37 
Articles 15(3), 16 to 22 and 26 to 29  of Regulation (EC) No 765/2008 shall apply to PPE covered by Article 2(1) of this Regulation.
Article 38 

1. Where the market surveillance  authority has  sufficient reason to believe that PPE covered by this Regulation presents a risk to the health or safety of persons,  the authority  shall carry out an evaluation in relation to the PPE concerned covering all relevant requirements laid down in this Regulation. The relevant economic operators shall cooperate as necessary with the market surveillance  authority  for that purpose.Where, in the course of the evaluation referred to in the first subparagraph, the market surveillance   authority finds  that the PPE does not comply with the requirements laid down in this Regulation,  the authority  shall without delay require the relevant economic operator to take all appropriate corrective action to bring the PPE into compliance with those requirements, to withdraw the PPE from the market, or to recall it within a reasonable period, commensurate with the nature of the risk, as the authority may prescribe.The market surveillance  authority  shall inform the relevant  approved  body accordingly.Article 21 of Regulation (EC) No 765/2008 shall apply to the measures referred to in the second subparagraph of this paragraph.
2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3. The economic operator shall ensure that all appropriate corrective action is taken in respect of all the PPE concerned that it has made available on the market ....
4. Where the relevant economic operator does not take adequate corrective action within the period referred to in the second subparagraph of paragraph 1, the market surveillance  authority  shall take all appropriate ... measures to prohibit or restrict the PPE being made available on  the market, to withdraw the PPE from that market or to recall it....
5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Article 39 
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Article 40 

1. Where, having carried out an evaluation under Article 38(1),  the enforcement authority  finds that although PPE is in compliance with this Regulation, it presents a risk to the health or safety of persons, it shall require the relevant economic operator to take all appropriate measures to ensure that the PPE concerned, when placed on the market, no longer presents that risk, to withdraw the PPE from the market or to recall it within a reasonable period, commensurate with the nature of the risk, as it may prescribe.
2. The economic operator shall ensure that corrective action is taken in respect of all the PPE concerned that he has made available on the market ....
3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Article 41 

1. Without prejudice to Article 38, where  the enforcement authority  makes one of the following findings, it shall require the relevant economic operator to put an end to the non-compliance concerned:
(a) the  UK  marking has been affixed in violation of Article 30 of Regulation (EC) No 765/2008 or of Article 17 of this Regulation;
(b) the  UK  marking has not been affixed;
(c) the identification number of the  approved  body involved in the production control phase has been affixed in violation of Article 17 or has not been affixed;
(d) the ... declaration of conformity has not been drawn up or has not been drawn up correctly;
(e) the technical documentation is either not available or not complete;
(f) the information referred to in Article 8(6) or Article 10(3) is absent, false or incomplete;
(g) any other administrative requirement provided for in Article 8 or Article 10 is not fulfilled.
2. Where the non-compliance referred to in paragraph 1 persists, the  enforcement authority  shall take all appropriate measures to restrict or prohibit the PPE being made available on the market or ensure that it is recalled or withdrawn from the market.
CHAPTER VII
Article 42 

1. In order to take into account technical progress and knowledge or new scientific evidence with respect to the category of a specific risk, the Secretary of State may, by regulations, amend Annex I by reclassifying the risk from one category to another.
2. Regulations made under paragraph 1 must be made by statutory instrument, subject to annulment in pursuance of a resolution of either House of Parliament.
3. Any power to make regulations under this Article includes power to make—
(a) different provision for different purposes;
(b) consequential, supplementary, transitional or transitory provision or savings.
Article 43 
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Article 44 
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CHAPTER VIII
Article 45 
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Article 46 
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Article 47 

1. In this Article,  “pre-exit period” means the period beginning with 21 April 2018 and ending immediately before  IP completion day.
2. Subject to paragraph 3, where PPE was made available on the market during the pre-exit period, despite the amendments made by Schedule 35 of the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, any obligation to which a person was subject under Regulation 2016/425 (pre-exit), continues to have effect as it did immediately before IP completion day, in relation to that PPE.
(3.) Paragraph 2 does not apply to—
(a) any obligation of the enforcement authority to inform the European Commission or the member States of any matter, or
(b) any obligation to take action outside of the United Kingdom in relation to that PPE.
(4.) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(5.) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(6.) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Article 48 
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......
...
ANNEX I
This Annex lays down the categories of risk against which PPE is intended to protect users.

Category I includes exclusively the following minimal risks:


((a)) superficial mechanical injury;
((b)) contact with cleaning materials of weak action or prolonged contact with water;
((c)) contact with hot surfaces not exceeding 50 °C;
((d)) damage to the eyes due to exposure to sunlight (other than during observation of the sun);
((e)) atmospheric conditions that are not of an extreme nature.

Category II includes risks other than those listed in Categories I and III;

Category III includes exclusively the risks that may cause very serious consequences such as death or irreversible damage to health relating to the following:


((a)) substances and mixtures which are hazardous to health;
((b)) atmospheres with oxygen deficiency;
((c)) harmful biological agents;
((d)) ionising radiation;
((e)) high-temperature environments the effects of which are comparable to those of an air temperature of at least 100 °C;
((f)) low-temperature environments the effects of which are comparable to those of an air temperature of – 50 °C or less;
((g)) falling from a height;
((h)) electric shock and live working;
((i)) drowning;
((j)) cuts by hand-held chainsaws;
((k)) high-pressure jets;
((l)) bullet wounds or knife stabs;
((m)) harmful noise.

ANNEX II 1. The essential health and safety requirements laid down in this Regulation are compulsory.
 2. Obligations related to essential health and safety requirements apply only where the corresponding risk exists for the PPE in question.
 3. The essential health and safety requirements are to be interpreted and applied in such a way as to take into account the state of the art and current practice at the time of design and manufacture, as well as technical and economic considerations which are consistent with a high degree of health and safety protection.
 4. The manufacturer shall carry out a risk assessment in order to identify the risks which apply to his PPE. He shall then design and manufacture it taking into account that assessment.
 5. When designing and manufacturing the PPE, and when drafting the instructions, the manufacturer shall envisage not only the intended use of the PPE, but also the reasonably foreseeable uses. Where applicable, the health and safety of persons other than the user shall be ensured.

1. 
PPE must provide adequate protection against the risks against which it is intended to protect.
 1.1.  1.1.1. 
PPE must be designed and manufactured so that, in the foreseeable conditions of use for which it is intended, the user can perform the risk-related activity normally whilst enjoying appropriate protection of the highest level possible.
 1.1.2.  1.1.2.1. 
The optimum level of protection to be taken into account in the design is that beyond which the constraints imposed by the wearing of the PPE would prevent its effective use during the period of exposure to the risk or the normal performance of the activity.
 1.1.2.2. 
Where differing foreseeable conditions of use are such that several levels of the same risk can be distinguished, appropriate classes of protection must be taken into account in the design of the PPE.
 1.2.  1.2.1. 
PPE must be designed and manufactured so as not to create risks or other nuisance factors under foreseeable conditions of use.
 1.2.1.1. 
The materials of which the PPE is made, including any of their possible decomposition products, must not adversely affect the health or safety of users.
 1.2.1.2. 
Any part of the PPE that is in contact or is liable to come into contact with the user when the PPE is worn must be free of rough surfaces, sharp edges, sharp points and the like which could cause excessive irritation or injuries.
 1.2.1.3. 
Any impediment caused by PPE to the actions to be carried out, the postures to be adopted and sensory perceptions shall be minimised. Furthermore, use of the PPE must not engender actions which might endanger the user.
 1.3.  1.3.1. 
PPE must be designed and manufactured in such a way as to facilitate its correct positioning on the user and to remain in place for the foreseeable period of use, bearing in mind ambient factors, the actions to be carried out and the postures to be adopted. For this purpose, it must be possible to adapt the PPE to fit the morphology of the user by all appropriate means, such as adequate adjustment and attachment systems or the provision of an adequate range of sizes.
 1.3.2. 
PPE must be as light as possible without prejudicing its strength and effectiveness.

PPE must satisfy the specific additional requirements in order to provide adequate protection against the risks for which it is intended and PPE must be capable of withstanding environmental factors in the foreseeable conditions of use.
 1.3.3. 
If the same manufacturer places on the market several PPE models of different types in order to ensure the simultaneous protection of adjacent parts of the body, they must be compatible.
 1.3.4. 
Protective clothing containing removable protectors constitutes PPE and shall be assessed as a combination during conformity assessment procedures.
 1.4. 
In addition to the name and address of the manufacturer, the instructions that must be supplied with the PPE must contain all relevant information on:


((a)) instructions for storage, use, cleaning, maintenance, servicing and disinfection. Cleaning, maintenance or disinfectant products recommended by manufacturers must have no adverse effect on the PPE or the user when applied in accordance with the relevant instructions;
((b)) performance as recorded during relevant technical tests to check the levels or classes of protection provided by the PPE;
((c)) where applicable, accessories that may be used with the PPE and the characteristics of appropriate spare parts;
((d)) where applicable, the classes of protection appropriate to different levels of risk and the corresponding limits of use;
((e)) where applicable, the month and year or period of obsolescence of the PPE or of certain of its components;
((f)) where applicable, the type of packaging suitable for transport;
((g)) the significance of any markings (see point 2.12);
((h)) the risk against which the PPE is designed to protect;
((i)) the reference to this Regulation and, where applicable, the references to other  relevant United Kingdom  legislation;
((j)) the name, address and identification number of the  approved  body or bodies involved in the conformity assessment of the PPE;
((k)) references to the relevant  designated  standard(s) used, including the date of the standard(s), or references to the other technical specifications used;
((l)) the internet address where the ... declaration of conformity can be accessed.

The information referred to in points (i), (j), (k) and (l) need not be contained in the instructions supplied by the manufacturer if the ... declaration of conformity accompanies the PPE.

2.  2.1. 
If PPE incorporates adjustment systems, the latter must be designed and manufactured so that, after adjustment, they do not become undone unintentionally in the foreseeable conditions of use.
 2.2. 
PPE must be designed and manufactured in a way that perspiration resulting from use is minimised. Otherwise it must be equipped with means of absorbing perspiration.
 2.3. 
Any restriction of the user's face, eyes, field of vision or respiratory system by the PPE shall be minimised.

The screens for those types of PPE must have a degree of optical neutrality that is compatible with the degree of precision and the duration of the activities of the user.

If necessary, such PPE must be treated or provided with means to prevent misting-up.

Models of PPE intended for users requiring sight correction must be compatible with the wearing of spectacles or contact lenses.
 2.4. 
If it is known that the design performance of new PPE may be significantly affected by ageing, the month and year of manufacture and/or, if possible, the month and year of obsolescence must be indelibly and unambiguously marked on each item of PPE placed on the market and on its packaging.

If the manufacturer is unable to give an undertaking with regard to the useful life of the PPE, his instructions must provide all the information necessary to enable the purchaser or user to establish a reasonable obsolescence month and year, taking into account the quality level of the model and the effective conditions of storage, use, cleaning, servicing and maintenance.

Where appreciable and rapid deterioration in PPE performance is likely to be caused by ageing resulting from the periodic use of a cleaning process recommended by the manufacturer, the latter must, if possible, affix a marking to each item of PPE placed on the market indicating the maximum number of cleaning operations that may be carried out before the equipment needs to be inspected or discarded. Where such a marking is not affixed, the manufacturer must give that information in his instructions.
 2.5. 
Where the foreseeable conditions of use include, in particular, the risk of the PPE being caught up by a moving object thereby creating a danger for the user, the PPE must be designed and manufactured in such a way that a constituent part will break or tear, thereby eliminating the danger.
 2.6. 
PPE intended for use in potentially explosive atmospheres must be designed and manufactured in such a way that it cannot be the source of an electric, electrostatic or impact-induced arc or spark likely to cause an explosive mixture to ignite.
 2.7. 
Those types of PPE must be designed and manufactured in such a way as to minimise the time required for putting on and removing the equipment.

Where PPE comprises fixing systems enabling the PPE to be maintained in the correct position on the user or removed, it must be possible to operate such systems quickly and easily.
 2.8. 
The instructions supplied by the manufacturer with PPE for intervention in very dangerous situations must include, in particular, data intended for competent, trained persons who are qualified to interpret them and ensure their application by the user.

The instructions must also describe the procedure to be adopted in order to verify that PPE is correctly adjusted and functional when worn by the user.

Where PPE incorporates an alarm which is activated in the absence of the level of protection normally provided, the alarm must be designed and placed so that it can be perceived by the user in the foreseeable conditions of use.
 2.9. 
Where PPE incorporates components which can be attached, adjusted or removed by the user for replacement purposes, such components must be designed and manufactured so that they can be easily attached, adjusted and removed without tools.
 2.10. 
Where PPE incorporates a connexion system permitting its connection to other complementary equipment, the means of attachment must be designed and manufactured in such a way as to enable it to be mounted only on appropriate equipment.
 2.11. 
Where PPE incorporates a fluid circulation system, the latter must be chosen or designed and placed in such a way as to permit adequate fluid renewal in the vicinity of the entire part of the body to be protected, irrespective of the actions, postures or movements of the user under the foreseeable conditions of use.
 2.12. 
Where PPE bears one or more identification markings or indicators directly or indirectly relating to health and safety, those identification markings or indicators must, if possible, take the form of ... pictograms or ideograms. They must be perfectly visible and legible and remain so throughout the foreseeable useful life of the PPE. In addition, those markings must be complete, precise and comprehensible so as to prevent any misinterpretation. In particular, where such markings include words or sentences, the latter must be written in  English.

Where PPE is too small to allow all or part of the necessary marking to be affixed, the relevant information must be mentioned on the packaging and in the manufacturer's instructions.
 2.13. 
PPE intended for foreseeable conditions of use in which the user's presence must be visibly and individually signalled must have one (or more) judiciously positioned means or devices for emitting direct or reflected visible radiation of appropriate luminous intensity and photometric and colorimetric properties.
 2.14. 
PPE intended to protect the user against several potentially simultaneous risks must be designed and manufactured in such a way as to satisfy, in particular, the essential health and safety requirements specific to each of those risks.

3.  3.1.  3.1.1. 
PPE intended to protect against this type of risk must be sufficiently shock-absorbent to prevent injury resulting, in particular, from the crushing or penetration of the protected part, at least up to an impact-energy level above which the excessive dimensions or mass of the means of shock-absorption would preclude effective use of the PPE for the foreseeable period of wear.
 3.1.2.  3.1.2.1. 
The outsoles of protective footwear intended to prevent slipping must be designed and manufactured or equipped with additional means so as to ensure adequate grip, having regard to the nature or state of the surface.
 3.1.2.2. 
PPE intended to prevent falls from a height or their effects must incorporate a body harness and a connexion system which can be connected to a reliable external anchorage point. It must be designed and manufactured so that, under the foreseeable conditions of use, the vertical drop of the user is minimised to prevent collision with obstacles while the braking force does not attain the threshold value at which physical injury or the opening or breakage of any PPE component which might cause the user to fall can be expected to occur.

Such PPE must also ensure that, after braking, the user is maintained in a correct position in which he may await help if necessary.

The manufacturer's instructions must specify, in particular, all relevant information relating to:


((a)) the characteristics required for the reliable external anchorage point and the necessary minimum clearance below the user;
((b)) the proper way of putting on the body harness and of attaching the connexion system to the reliable external anchorage point.
 3.1.3. 
PPE designed to prevent the effects of mechanical vibrations must be capable of ensuring adequate attenuation of harmful vibration components for the part of the body at risk.
 3.2. 
PPE designed to protect a part of the body against static compressive stress must be sufficiently capable of attenuating its effects so as to prevent serious injury or chronic complaints.
 3.3. 
PPE constituent materials and other components designed to protect all or a part of the body against superficial injuries, such as abrasion, perforation, cuts or bites, must be chosen or designed and incorporated so as to ensure that those types of PPE provide sufficient resistance to abrasion, perforation and gashing (see also point 3.1) under the foreseeable conditions of use.
 3.4.  3.4.1. 
PPE designed to prevent drowning must be capable of returning to the surface as quickly as possible, without danger to health, a user who may be exhausted or unconscious after falling into a liquid medium, and of keeping the user afloat in a position which permits breathing while awaiting help.

PPE may be wholly or partially inherently buoyant or may be inflated by gas which can be manually or automatically released, or inflated orally.

Under the foreseeable conditions of use:


((a)) PPE must, without prejudice to its satisfactory operation, be capable of withstanding the effects of impact with the liquid medium and the environmental factors inherent in that medium;
((b)) inflatable PPE must be capable of inflating rapidly and fully.

Where particular foreseeable conditions of use so require, certain types of PPE must also satisfy one or more of the following additional requirements:


((a)) they must have all the inflation devices referred to in the second subparagraph, and/or a light or sound-signalling device;
((b)) they must have a device for hitching and attaching the body so that the user may be lifted out of the liquid medium;
((c)) they must be suitable for prolonged use throughout the period of activity exposing the user, possibly dressed, to the risk of falling into the liquid medium or requiring the user's immersion in it.
 3.4.2. 
Clothing intended to ensure an effective degree of buoyancy, depending on its foreseeable use, shall be safe when worn and afford positive support in the liquid medium. In foreseeable conditions of use, this PPE must not restrict the user's freedom of movement but must enable the user, in particular, to swim or take action to escape from danger or to rescue other persons.
 3.5. 
PPE intended to prevent the harmful effects of noise must be capable of attenuating the latter so that the exposure of the user does not exceed the limit values laid down  in the Control of Noise at Work Regulations 2005 (S.I. 2005/1643) and the Control of Noise at Work Regulations (Northern Ireland) 2006 (S.R. 2006 No.1).

Each item of PPE must bear labelling indicating the noise attenuation level provided by the PPE. Should that not be possible, the labelling must be fixed to the packaging.
 3.6. 
PPE designed to protect all or a part of the body against the effects of heat and/or fire must possess thermal insulation capacity and mechanical strength appropriate to the foreseeable conditions of use.
 3.6.1. 
Constituent materials and other components intended for protection against radiant and convective heat must possess an appropriate coefficient of transmission of incident heat flux and be sufficiently incombustible to preclude any risk of spontaneous ignition under the foreseeable conditions of use.

Where the external surface of those materials and components must be reflective, the reflective power must be appropriate to the intensity of the heat flux due to radiation in the infrared range.

Materials and other components of equipment intended for brief use in high-temperature environments and of PPE which may be splashed by hot products such as molten material must also possess sufficient thermal capacity to retain most of the stored heat until after the user has left the danger area and removed the PPE.

PPE materials and other components which may be splashed by hot products must also possess sufficient mechanical-impact absorbency (see point 3.1).

PPE materials and other components which may accidentally come into contact with flame and those used in the manufacture of industrial or fire-fighting equipment must also possess a degree of non-flammability and thermal or arc heat protection corresponding to the risk class associated with the foreseeable conditions of use. They must not melt when exposed to flames nor contribute to flame propagation.
 3.6.2. 
Under the foreseeable conditions of use:


((a)) the quantity of heat transmitted by PPE to the user must be sufficiently low to prevent the heat accumulated during wear in the part of the body at risk from attaining, under any circumstances, the pain or health impairment threshold;
((b)) PPE must, if necessary, prevent liquid or steam penetration and must not cause burns resulting from contact between its protective integument and the user.

If PPE incorporates refrigeration devices for the absorption of incident heat by means of liquid evaporation or solid sublimation, the design of such devices must be such that any volatile substances released are discharged beyond the outer protective integument and not towards the user.

If PPE incorporates a breathing device, that device must adequately fulfil the protective function assigned to it under the foreseeable conditions of use.

The manufacturer's instructions accompanying PPE intended for brief use in high-temperature environments must, in particular, provide all relevant data for the determination of the maximum permissible user exposure to the heat transmitted by the equipment when used in accordance with its intended purpose.
 3.7. 
PPE designed to protect all or a part of the body against the effects of cold must possess thermal insulating capacity and mechanical strength appropriate to the foreseeable conditions of use for which it is intended.
 3.7.1. 
Constituent materials and other components suitable for protection against cold must possess a coefficient of transmission of incident thermal flux as low as required under the foreseeable conditions of use. Flexible materials and other components of PPE intended for use in a low-temperature environment must retain the degree of flexibility required for the necessary gestures and postures.

PPE materials and other components which may be splashed by cold products must also possess sufficient mechanical-impact absorbency (see point 3.1).
 3.7.2. 
Under the foreseeable conditions of use, the following requirements apply:


((a)) the flux transmitted by PPE to the user must be sufficiently low to prevent the cold accumulated during wear at any point on the part of the body being protected, including the tips of fingers and toes in the case of hands or feet, from attaining, under any circumstances, the pain or health impairment threshold;
((b)) PPE must as far as possible prevent the penetration of such liquids as rain water and must not cause injuries resulting from contact between its cold protective integument and the user.

If PPE incorporates a breathing device, that device must adequately fulfil the protective function assigned to it under the foreseeable conditions of use.

The manufacturer's instructions accompanying PPE intended for brief use in low-temperature environments must provide all relevant data concerning the maximum permissible user exposure to the cold transmitted by the equipment.
 3.8.  3.8.1. 
PPE designed to protect all or part of the body against the effects of electric current must be sufficiently insulated against the voltages to which the user is likely to be exposed under the most unfavourable foreseeable conditions.

To this end, the constituent materials and other components of those types of PPE must be chosen or designed and incorporated so as to ensure that the leakage current measured through the protective integument under test conditions at voltages correlated with those likely to be encountered in situ is minimised and, in any event, below a maximum conventional permissible value which correlates with the tolerance threshold.

Together with their packaging, PPE types intended exclusively for use during work or activities in electrical installations which are or may be under tension must bear markings indicating, in particular, their protection class or corresponding operating voltage, their serial number and their date of manufacture. A space must also be provided outside the protective integument of such PPE for the subsequent inscription of the date of entry into service and those of the periodic tests or inspections to be conducted.

The manufacturer's instructions must indicate, in particular, the exclusive use for which those PPE types are intended and the nature and frequency of the dielectric tests to which they are to be subjected during their useful life.
 3.8.2. 
Conductive PPE intended for live working at high voltages shall be designed and manufactured in such a way as to ensure that there is no difference of potential between the user and the installations on which he is intervening.
 3.9.  3.9.1. 
PPE designed to prevent acute or chronic eye damage from sources of non-ionising radiation must be capable of absorbing or reflecting the majority of the energy radiated in the harmful wavelengths without unduly affecting the transmission of the innocuous part of the visible spectrum, the perception of contrasts and the ability to distinguish colours where required by the foreseeable conditions of use.

To that end, eye protective equipment must be designed and manufactured so as to possess, for each harmful wavelength, a spectral transmission factor such that the radiant-energy illumination density capable of reaching the user's eye through the filter is minimised and under no circumstances exceeds the maximum permissible exposure value. PPE designed to protect the skin against non-ionising radiation must be capable of absorbing or reflecting the majority of the energy radiated in the harmful wavelengths.

Furthermore, the glasses must not deteriorate or lose their properties as a result of the effects of radiation emitted under the foreseeable conditions of use and all marketed specimens must bear the protection-factor number corresponding to the spectral distribution curve of their transmission factor.

Glasses suitable for radiation sources of the same type must be classified in the ascending order of their protection factors and the manufacturer's instructions must indicate, in particular, how to select the appropriate PPE taking into account the relevant conditions of use such as the distance from the source and the spectral distribution of the energy radiated at that distance.

The relevant protection factor number must be marked on all specimens of filtering eye protective equipment by the manufacturer.
 3.9.2.  3.9.2.1. 
PPE constituent materials and other components designed to protect all or a part of the body against radioactive dust, gases, liquids or mixtures thereof must be chosen or designed and incorporated so as to ensure that this equipment effectively prevents the penetration of the contaminants under the foreseeable conditions of use.

Depending on the nature or condition of these contaminants, the necessary leak-tightness can be provided by the impermeability of the protective integument and/or by any other appropriate means, such as ventilation and pressurisation systems designed to prevent the back-scattering of these contaminants.

Any decontamination measures to which PPE is subject must not prejudice its possible reuse during the foreseeable useful life of those types of equipment.
 3.9.2.2. 
PPE intended to provide complete user protection against external irradiation or, failing this, adequate attenuation thereof, must be designed to counter only weak electron (e.g. beta) or weak photon (e.g. X, gamma) radiation.

The constituent materials and other components of these types of PPE must be chosen or designed and incorporated so as to provide the degree of user protection required by the foreseeable conditions of use without leading to an increase in exposure time as a result of the impedance of user gestures, posture or movement (see point 1.3.2).

PPE must bear a mark indicating the type and equivalent thickness of the constituent material(s) suitable for the foreseeable conditions of use.
 3.10.  3.10.1. 
PPE intended for the protection of the respiratory system must make it possible to supply the user with breathable air when exposed to a polluted atmosphere and/or an atmosphere having an inadequate oxygen concentration.

The breathable air supplied to the user by PPE must be obtained by appropriate means, for example after filtration of the polluted air through PPE or by supply from an external unpolluted source.

The constituent materials and other components of those types of PPE must be chosen or designed and incorporated so as to ensure appropriate user respiration and respiratory hygiene for the period of wear concerned under the foreseeable conditions of use.

The leak-tightness of the facepiece and the pressure drop on inspiration and, in the case of the filtering devices, purification capacity must keep contaminant penetration from a polluted atmosphere low enough not to be prejudicial to the health or hygiene of the user.

The PPE must bear details of the specific characteristics of the equipment which, in conjunction with the instructions, enable a trained and qualified user to employ the PPE correctly.

In the case of filtering equipment, the manufacturer's instructions must also indicate the time limit for the storage of new filters kept in their original packaging.
 3.10.2. 
PPE intended to prevent the surface contact of all or part of the body with substances and mixtures which are hazardous to health or with harmful biological agents must be capable of preventing the penetration or permeation of such substances and mixtures and agents through the protective integument under the foreseeable conditions of use for which the PPE is intended.

To this end, the constituent materials and other components of those types of PPE must be chosen or designed and incorporated so as to ensure, as far as possible, complete leak-tightness, which will allow where necessary prolonged daily use or, failing this, limited leak-tightness necessitating a restriction of the period of wear.

Where, by virtue of their nature and the foreseeable conditions of their use, certain substances and mixtures which are hazardous to health or harmful biological agents possess high penetrative power which limits the duration of the protection provided by the PPE in question, the latter must be subjected to standard tests with a view to their classification on the basis of their performance. PPE which is considered to be in conformity with the test specifications must bear a marking indicating, in particular, the names or, in the absence of the names, the codes of the substances used in the tests and the corresponding standard period of protection. The manufacturer's instructions must also contain, in particular, an explanation of the codes (if necessary), a detailed description of the standard tests and all appropriate information for the determination of the maximum permissible period of wear under the different foreseeable conditions of use.
 3.11. 
The breathing equipment must make it possible to supply the user with a breathable gaseous mixture, under foreseeable conditions of use and taking account in particular of the maximum depth of immersion.

Where the foreseeable conditions of use so require, the diving equipment must comprise the following:


((a)) a suit which protects the user against cold (see point 3.7) and/or pressure resulting from the depth of immersion (see point 3.2);
((b)) an alarm designed to give the user prompt warning of an approaching failure in the supply of breathable gaseous mixture (see point 2.8);
((c)) a lifesaving device enabling the user to return to the surface (see point 3.4.1).

ANNEX III

The technical documentation shall specify the means used by the manufacturer to ensure the conformity of the PPE with the applicable essential health and safety requirements referred to in Article 5 and set out in Annex II.
The technical documentation shall include at least the following elements:

((a)) a complete description of the PPE and of its intended use;
((b)) an assessment of the risks against which the PPE is intended to protect;
((c)) a list of the essential health and safety requirements that are applicable to the PPE;
((d)) design and manufacturing drawings and schemes of the PPE and of its components, sub-assemblies and circuits;
((e)) the descriptions and explanations necessary for the understanding of the drawings and schemes referred to in point (d) and of the operation of the PPE;
((f)) the references of the  designated  standards referred to in Article 14 that have been applied for the design and manufacture of the PPE. In the event of partial application of designated standards, the documentation shall specify the parts which have been applied;
((g)) where  designated  standards have not been applied or have been only partially applied, descriptions of the other technical specifications that have been applied in order to satisfy the applicable essential health and safety requirements;
((h)) the results of the design calculations, inspections and examinations carried out to verify the conformity of the PPE with the applicable essential health and safety requirements;
((i)) reports on the tests carried out to verify the conformity of the PPE with the applicable essential health and safety requirements and, where appropriate, to establish the relevant protection class;
((j)) a description of the means used by the manufacturer during the production of the PPE to ensure the conformity of the PPE produced with the design specifications;
((k)) a copy of the manufacturer's instructions and information set out in point 1.4 of Annex II;
((l)) for PPE produced as a single unit to fit an individual user, all the necessary instructions for manufacturing such PPE on the basis of the approved basic model;
((m)) for PPE produced in series where each item is adapted to fit an individual user, a description of the measures to be taken by the manufacturer during the fitting and production process to ensure that each item of PPE complies with the approved type and with the applicable essential health and safety requirements.

ANNEX IV
INTERNAL PRODUCTION CONTROL  1. Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4, and ensures and declares on his sole responsibility that the PPE concerned satisfies the applicable requirements of this Regulation.
 2. 
The manufacturer shall establish the technical documentation described in Annex III.
 3. 
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured PPE with the technical documentation referred to in point 2 and with the applicable requirements of this Regulation.
 4.  4.1. The manufacturer shall affix the  UK  marking to each individual PPE that satisfies the applicable requirements of this Regulation.
 4.2. 
A copy of the ... declaration of conformity shall be made available to the relevant authorities upon request.
 5. 
The manufacturer's obligations set out in point 4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

ANNEX V
... TYPE-EXAMINATION  1. ... Type-examination is the part of a conformity assessment procedure in which  an approved  body examines the technical design of PPE and verifies and attests that the technical design of the PPE meets the requirements of this Regulation that apply to it.
 2. ... Type-examination shall be carried out by assessment of the adequacy of the technical design of the PPE through examination of the technical documentation, plus examination of a specimen, representative of the production envisaged, of the complete PPE (production type).
 3. 
The manufacturer shall lodge an application for ... type-examination with a single  approved  body of his choice.

The application shall include:


((a)) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;
((b)) a written declaration that the same application has not been lodged with any other approved body;
((c)) the technical documentation described in Annex III;
((d)) the specimen(s) of the PPE representative of the production envisaged. The approved body may request further specimens if needed for carrying out the test programme. For PPE produced in series where each item is adapted to fit an individual user, specimens shall be provided that are representative of the range of different users, and for PPE produced as a single unit to accommodate the special needs of an individual user, a basic model shall be provided.
 4. 
The  approved  body shall:


((a)) examine the technical documentation to assess the adequacy of the technical design of the PPE. In conducting such an examination, point (j) of Annex III need not be taken into account;
((b)) for PPE produced in series where each item is adapted to fit an individual user, examine the description of the measures to assess their adequacy;
((c)) for PPE produced as a single unit to fit an individual user, examine the instructions for manufacturing such PPE on the basis of the approved basic model to assess their adequacy;
((d)) verify that the specimen(s) have been manufactured in conformity with the technical documentation, and identify the elements which have been designed in accordance with the applicable provisions of the relevant  designated  standards as well as the elements which have been designed in accordance with other technical specifications;
((e)) carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant  designated  standards, these have been applied correctly;
((f)) carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant designated standards have not been applied, the solutions adopted by the manufacturer, including those in other technical specifications applied, meet the corresponding essential health and safety requirements and have been applied correctly.
 5. 
The  approved  body shall draw up an evaluation report that records the activities undertaken in accordance with point 4 and their outcomes. Without prejudice to its obligations vis-à-vis the  Secretary of State, the  approved  body shall release the content of that report, in full or in part, only with the agreement of the manufacturer.
 6.  6.1. 
The period of validity of a newly issued certificate and, where appropriate, of a renewed certificate shall not exceed five years.
 6.2. 

((a)) the name and identification number of the  approved  body;
((b)) the name and address of the manufacturer and, if the application is lodged by the authorised representative, the latter's name and address;
((c)) identification of the PPE covered by the certificate (type number);
((d)) a statement that the PPE type complies with the applicable essential health and safety requirements;
((e)) where  designated  standards have been fully or partially applied, the references of those standards or parts thereof;
((f)) where other technical specifications have been applied, their references;
((g)) where applicable, the performance level(s) or protection class of the PPE;
((h)) for PPE produced as a single unit to fit an individual user, the range of permissible variations of relevant parameters based on the approved basic model;
((i)) the date of issue, the date of expiry and, where appropriate, the date(s) of renewal;
((j)) any conditions attached to the issue of the certificate;
((k)) for category III PPE, a statement that the certificate shall only be used in conjunction with one of the conformity assessment procedures referred to in point (c) of Article 19.
 6.3. The ... type-examination certificate may have one or more annexes attached.
 6.4. Where the type does not satisfy the applicable essential health and safety requirements, the  approved  body shall refuse to issue  a  type-examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.
 7.  7.1. The  approved  body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable essential health and safety requirements, and shall determine whether such changes require further investigation. If so, the  approved  body shall inform the manufacturer accordingly.
 7.2. The manufacturer shall inform the  approved  body that holds the technical documentation relating to the ... type-examination certificate of all modifications to the approved type and of all modifications of the technical documentation that may affect the conformity of the PPE with the applicable essential health and safety requirements or the conditions for validity of that certificate. Such modifications shall require additional approval in the form of an addition to the original ... type-examination certificate.
 7.3. The manufacturer shall ensure that the PPE continues to fulfil the applicable essential health and safety requirements in light of the state of the art.
 7.4. 

((a)) in the case of a modification to the approved type referred to in point 7.2;
((b)) in the case of a change in the state of the art referred to in point 7.3;
((c)) at the latest, before the date of expiry of the certificate.

In order to allow the  approved  body to fulfil its tasks, the manufacturer shall submit his application at the earliest 12 months and at the latest 6 months prior to the expiry date of the ... type-examination certificate.
 7.5. The  approved  body shall examine the PPE type and, where necessary in the light of the changes made, carry out the relevant tests to ensure that the approved type continues to fulfil the applicable essential health and safety requirements. If the  approved  body is satisfied that the approved type continues to fulfil the applicable health and safety requirements, it shall renew the ... type-examination certificate. The approved body shall ensure that the review procedure is finalised before the expiry date of the ... type-examination certificate.
 7.6. 

((a)) his name and address and data identifying the ... type-examination certificate concerned;
((b)) confirmation that there has been no modification to the approved type as referred to in point 7.2, including materials, sub-components or sub-assemblies, nor to the relevant  designated  standards or other technical specifications applied;
((c)) confirmation that there has been no change in the state of the art as referred to in point 7.3;
((d)) where not already supplied, copies of current product drawings and photographs, product marking and information supplied by the manufacturer; and
((e)) for category III products, where not already available to the approved body, information on the results of the supervised product checks at random intervals carried out in accordance with Annex VII, or on the results of audits of his quality system carried out in accordance with Annex VIII.

Where the approved body has confirmed that no modification to the approved type referred to in point 7.2 and no change in the state of the art referred to in point 7.3 has occurred, the simplified review procedure shall be applied and the examinations and tests referred to in point 7.5 shall not be carried out. In such cases, the approved body shall renew the ... type-examination certificate.

The costs associated with that renewal shall be proportionate to the administrative burden of the simplified procedure.

If the approved body finds that a change in the state of the art referred to in point 7.3 has occurred, the procedure set out in point 7.5 shall apply.
 7.7. If, following the review, the  approved  body concludes that the ... type-examination certificate is no longer valid, the body shall withdraw it and the manufacturer shall cease the placing on the market of the PPE concerned.
 8. Each  approved  body shall inform  the Secretary of State  concerning the ... type-examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to the Secretary of State the list of such certificates and/or any additions thereto refused, suspended or otherwise restricted.
Each approved body shall inform the other approved bodies concerning the ... type-examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning such certificates and/or additions thereto which it has issued.
The Secretary of State  and the other approved bodies may, on request, obtain a copy of the ... type-examination certificates and/or additions thereto.  The Secretary of State may on request  obtain a copy of the technical documentation and the results of the examinations carried out by the approved body.
The approved body shall keep a copy of the ... type-examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, for a period of five years after the expiry of the validity of that certificate.
 9. The manufacturer shall keep a copy of the ... type-examination certificate, its annexes and additions, together with the technical documentation at the disposal of the national authorities, for 10 years after the PPE has been placed on the market.
 10. The manufacturer's authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 7.2, 7.4 and 9, provided that they are specified in the mandate.

ANNEX VI
CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL  1. Conformity to type based on internal production control is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 3, and ensures and declares under his sole responsibility that the PPE concerned is in conformity with the type described in the ... type-examination certificate and satisfies the applicable requirements of this Regulation.
 2. 
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured PPE with the type described in the ... type-examination certificate and with the applicable requirements of this Regulation.
 3.  3.1. The manufacturer shall affix the  UK  marking to each individual PPE that is in conformity with the type described in the ... type-examination certificate and satisfies the applicable requirements of this Regulation.
 3.2. 
A copy of the ... declaration of conformity shall be made available to the relevant authorities upon request.
 4. 
The manufacturer's obligations set out in point 3 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

ANNEX VII
CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRODUCT CHECKS AT RANDOM INTERVALS  1. Conformity to type based on internal production control plus supervised product checks at random intervals is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3, 5.2 and 6, and ensures and declares on his sole responsibility that the PPE, which has been subject to the provisions of point 4, is in conformity with the type described in the ... type-examination certificate and satisfies the applicable requirements of this Regulation.
 2. 
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure the homogeneity of production and conformity of the manufactured PPE with the type described in the ... type-examination certificate and with the applicable requirements of this Regulation.
 3. 
Before placing PPE on the market, the manufacturer shall lodge an application for supervised product checks at random intervals with a single  approved  body of his choice.

The application shall include the following:


((a)) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address;
((b)) a written declaration that the same application has not been lodged with any other approved body;
((c)) the identification of the PPE concerned.

Where the chosen body is not the body that has carried out the ... type-examination, the application shall also include the following:


((a)) the technical documentation described in Annex III;
((b)) a copy of the ... type-examination certificate.
 4.  4.1. The  approved  body shall carry out product checks in order to verify the homogeneity of production and the conformity of the PPE with the type described in the ... type-examination certificate and with the applicable essential health and safety requirements.
 4.2. The product checks shall be carried out at least once a year, at random intervals determined by the  approved  body. The first product checks shall be carried out no more than one year after the date of issue of the ... type-examination certificate.
 4.3. An adequate statistical sample of the manufactured PPE shall be selected by the  approved  body at a place agreed between the body and the manufacturer. All items of PPE of the sample shall be examined, and appropriate tests set out in the relevant  designated  standard(s) and/or equivalent tests set out in other relevant technical specifications shall be carried out in order to verify the conformity of the PPE with the type described in the ... type-examination certificate and with the applicable essential health and safety requirements.
 4.4. Where the  approved  body referred to in point 3 is not the body that issued the relevant ... type-examination certificate, it shall contact that body in the event of difficulties in connection with the assessment of the conformity of the sample.
 4.5. The acceptance sampling procedure to be applied is intended to determine whether the manufacturing process ensures the homogeneity of production and performs within acceptable limits, with a view to ensuring conformity of the PPE.
 4.6. If the examination and testing reveal that the production is not homogeneous, or that the PPE does not comply with the type described in the ... type-examination certificate or with the applicable essential health and safety requirements, the  approved  body shall take measures appropriate to the fault(s) recorded and inform the  Secretary of State  thereof.
 5.  5.1. The  approved  body shall provide the manufacturer with a test report.
 5.2. The manufacturer shall keep the test report at the disposal of the national authorities for 10 years after the PPE has been placed on the market.
 5.3. The manufacturer shall, under the responsibility of the  approved  body, affix the approved body's identification number during the manufacturing process.
 6.  6.1. The manufacturer shall affix the  UK  marking and, under the responsibility of the  approved  body referred to in point 3, the latter's identification number to each individual item of PPE that is in conformity with the type described in the ... type-examination certificate and satisfies the applicable requirements of this Regulation.
 6.2. 
A copy of the ... declaration of conformity shall be made available to the relevant authorities upon request.
 7. 
The manufacturer's obligations may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. An authorised representative may not fulfil the manufacturer's obligations set out in point 2.

ANNEX VIII
CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS  1. Conformity to type based on quality assurance of the production process is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 5 and 6, and ensures and declares on his sole responsibility that the PPE concerned is in conformity with the type described in the ... type-examination certificate and satisfies the applicable requirements of this Regulation.
 2. 
The manufacturer shall operate an approved quality system for production, final product inspection and testing of the PPE concerned as specified in point 3, and shall be subject to surveillance as specified in point 4.
 3.  3.1. The manufacturer shall lodge an application for assessment of his quality system with a single  approved  body of his choice.
The application shall include:

((a)) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;
((b)) the address of the manufacturer's premises where the audits can be carried out;
((c)) a written declaration that the same application has not been lodged with any other approved body;
((d)) the identification of the PPE concerned;
((e)) the documentation concerning the quality system.
Where the chosen body is not the body that has carried out the ... type-examination, the application shall also include the following:

((a)) the technical documentation of the PPE described in Annex III;
((b)) a copy of the ... type-examination certificate.
 3.2. The quality system shall ensure that the PPE is in conformity with the type described in the ... type-examination certificate and complies with the applicable requirements of this Regulation.
All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.
The quality system documentation shall, in particular, contain an adequate description of:

((a)) the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality;
((b)) the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;
((c)) the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out;
((d)) the quality records, such as inspection reports and test data, calibration data and qualification reports on the personnel concerned; and
((e)) the means of monitoring the achievement of the required product quality and the effective operation of the quality system.
 3.3. The  approved  body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2.
It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant  designated  standard.
In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the field of PPE and technology concerned, and knowledge of the applicable essential health and safety requirements. The audit shall include an assessment visit to the manufacturer's premises. The auditing team shall review the technical documentation of the PPE referred to in point 3.1 to verify the manufacturer's ability to identify the applicable essential health and safety requirements and to carry out the necessary examinations with a view to ensuring conformity of the PPE with those requirements.
The result of that assessment shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision.
 3.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.
 3.5. The manufacturer shall keep the approved body that has approved the quality system informed of any intended change to the quality system.
The  approved  body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.
It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.
 3.6. The  approved  body shall authorise the manufacturer to affix the approved body's identification number to each individual item of PPE that is in conformity with the type described in the ... type-examination certificate and satisfies the applicable requirements of this Regulation.
 4.  4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.
 4.2. The manufacturer shall, for assessment purposes, allow the  approved  body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:

((a)) the quality system documentation;
((b)) the quality records, such as inspection reports and test data, calibration data and qualification reports on the personnel concerned.
 4.3. The  approved  body shall carry out periodic audits, at least once a year, to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.
 4.4. In addition, the  approved  body may pay unexpected visits to the manufacturer. During such visits the approved body may, if necessary, carry out examinations or tests of the PPE, or have them carried out, in order to verify that the quality system is functioning correctly. The approved body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.
 5.  5.1. The manufacturer shall affix the  UK   marking and, under the responsibility of the  approved  body referred to in point 3.1, the latter's identification number to each individual item of PPE that is in conformity with the type described in the ... type-examination certificate and satisfies the applicable requirements of this Regulation.
 5.2. The manufacturer shall draw up a written ... declaration of conformity for each PPE model and keep it at the disposal of the  enforcement authority  for 10 years after the PPE has been placed on the market. The ... declaration of conformity shall identify the PPE model for which it has been drawn up.
A copy of the ... declaration of conformity shall be made available to the  enforcement authority  upon request.
 6. The manufacturer shall, for 10 years after the PPE has been placed on the market, keep at the disposal of the  enforcement authority:

((a)) the documentation referred to in point 3.1;
((b)) the information related to the change referred to in point 3.5, as approved;
((c)) the decisions and reports of the  approved  body referred to in points 3.5, 4.3 and 4.4.
 7. The  approved  body shall inform  the Secretary of State  of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to the Secretary of State the list of such quality system approvals refused, suspended or otherwise restricted.
The approved body shall inform the other approved bodies of quality system approvals which it has refused, suspended, withdrawn or otherwise restricted, and, upon request, of such quality system approvals which it has issued.
 8. 
The manufacturer's obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

ANNEX IX

1. PPE (product, type, batch or serial number):

2. Name and address of the manufacturer and, where applicable, his authorised representative:

3. This declaration of conformity is issued under the sole responsibility of the manufacturer:

4. Object of the declaration (identification of PPE allowing traceability; where necessary for the identification of the PPE, a colour image of sufficient clarity may be included):

5. The object of the declaration described in point 4 is in conformity with the relevant  statutory requirements: …

6. References to the relevant  designated  standards used, including the date of the standard, or references to the other technical specifications, including the date of the specification, in relation to which conformity is declared:

7. Where applicable, the  approved  body … (name, number) … performed the ... type-examination (Module B) and issued the ... type-examination certificate … (reference to that certificate).

8. Where applicable, the PPE is subject to the conformity assessment procedure … (either conformity to type based on internal production control plus supervised product checks at random intervals (Module C2) or conformity to type based on quality assurance of the production process (Module D)) … under surveillance of the  approved  body … (name, number).

9. Additional information:
Signed for and on behalf of: …
(place and date of issue):
(name, function) (signature):

ANNEX X

Directive 89/686/EEC This Regulation
Article 1(1) Articles 1 and 2(1)
Article 1(2) and (3) Article 3 point (1)
Article 1(4) Article 2(2)
Article 2(1) Article 4
Article 2(2) Article 6
Article 2(3) Article 7(2)
Article 3 Article 5
Article 4(1) Article 7(1)
Article 4(2) —
Article 5(1), (4), (5) —
Article 5(2) Article 14
Article 6 Article 44
Article 7 Articles 37-41
Article 8(1) Article 8(2) first subparagraph
Article 8(2)-(4) Articles 18 and 19 and Annex I
Article 9 Articles 20, 24(1), 25, and 30(1)
Article 10 Annex V
Article 11(A) Annex VII
Article 11(B) Annex VIII
Article 12(1) Article 15
Articles 12(2) and 13 Articles 16 and 17
Article 14 —
Article 15 —
Article 16(1) first subparagraph and (2) —
Article 16(1) second subparagraph Article 48(2)
Annex I Article 2(2)
Annex II Annex II
Annex III Annex III
Annex IV Article 16
Annex V Article 24(2)-(11)
Annex VI Annex IX