
1 
These Regulations may be cited as the Electro-medical Equipment (EEC Requirements) Regulations 1988 and shall come into force on 11th October 1988.
2 
In these Regulations—
 “the Act of 1968” means the Trade Descriptions Act 1968;
 “the Directive” means Council Directive 84/539/EEC on the approximation of the laws of the member States relating to electro-medical equipment used in human or veterinary medicine;
 “declaration” means a declaration which conforms with the specimen declaration contained in Annex IV to the Directive;
 “electro-medical equipment” means electro-medical equipment listed in Annex II to the Directive which is intended, by its nature, for use in human or veterinary medicine;
 “the reversed epsilon” means a mark which conforms with the specimen mark contained in Annex III to the Directive;
 “supply” has the same meaning as in section 46 of the Consumer Protection Act 1987 and includes offering to supply, agreeing to supply, exposing for supply and possessing for supply.
3 
Where any person supplies electro-medical equipment which is marked with the reversed epsilon (or with a mark so closely resembling it as to be likely to be taken to be the reversed epsilon) or to which a declaration has been applied but that equipment does not comply with the technical requirements contained in Annex I to the Directive that person shall be guilty of an offence.
4 

(1) The following provisions of the Act of 1968 shall (with necessary modifications) apply in relation to an offence under these Regulations as they apply in relation to an offence under that Act (modified where appropriate in relation to Northern Ireland by section 40(1) of that Act), that is to say sections 18, 19, 20, and 24.
(2) The following provisions of the Act of 1968 shall (with necessary modifications) apply in relation to the enforcement of these Regulations as they apply in relation to the enforcement of that Act (modified where appropriate in relation to Northern Ireland by section 40(1) of that Act), that is to say sections 26, 27, 28, 29 and 30(1).
(3) Section 33 of the Act of 1968 (modified in relation to Northern Ireland by section 40(1) of that Act) shall apply in relation to compensation for goods seized and detained under these Regulations as it applies to compensation for goods seized and detained under that Act.
5 

(1) In any proceedings against a person for an offence under any of the relevant statutory provisions (as defined by section 53(1) of the Health and Safety at Work etc Act 1974 or, as the case may be, article 2(2) of the Health and Safety at Work (Northern Ireland) Order 1978) which imposes requirements on grounds of safety relating to the manufacture of electro-medical equipment for use at work, it shall be a defence for that person to show that that equipment conforms with the requirements of the Directive.
(2) Where an improvement notice or prohibition notice has been served on any person pursuant to section 21 or, as the case may be, section 22 of the Health and Safety at Work etc Act 1974, or articles 23 or 24 of the Health and Safety at Work (Northern Ireland) Order 1978, if the person upon whom the notice was served appeals to an industrial tribunal pursuant to section 24 of the said Act or article 26 of the said Order and shows that the notice refers to grounds of safety relating to the manufacture of electro-medical equipment for use at work which conforms with the requirements of the Directive, the tribunal shall cancel the notice.
K. Clarke
One of Her Majesty’s Principal Secretaries of State
9th September 1988