
Article 1 
This Regulation shall apply to the importation and transit through the Community of an ‘intermediate product’, as defined in Article 2 of this Regulation.
Article 2 
An ‘intermediate product’ means a product derived from Category 3 material intended for the manufacture of medical devices, in vitro diagnostics or laboratory reagents, and whose design, transformation and manufacturing stages have been sufficiently completed in order to be regarded as processed products and to qualify the material for that purpose, except for the fact that it requires some further handling or transformation such as mixing, coating, assembling, packaging or labelling to make it suitable for placing on the market or putting into service in accordance with the Community legislation applicable to the final products concerned.
Article 3 
Member States shall authorise imports of the intermediate products that comply with the following conditions:

((a)) they come from a third country listed as member of the World Organisation for Animal Health (OIE) in the OIE Bulletin;
((b)) they come from a plant registered or approved by the competent authority of a third country referred to in point (a) of this Article in accordance with the conditions set out in Annex I to this Regulation;
((c)) they are derived exclusively from Category 3 material;
((d)) each consignment must be accompanied by a commercial document indicating:

((i)) the country of origin,
((ii)) the name of the establishment of production; and
((iii)) that the outer packaging of intermediate products is labelled ‘FOR MEDICAL DEVICES/IN VITRO DIAGNOSTICS/LABORATORY REAGENTS ONLY’.
The commercial document must be in at least one of the official languages of the EU Member State in which the inspection at the border inspection post shall be carried out and of the EU Member State of destination. These Member States may allow other languages, if necessary, accompanied by an official translation.
((e)) they are accompanied by a declaration of the importer in accordance with the model declaration set out in Annex II to this Regulation. The declaration must be in at least one of the official languages of the EU Member State in which the inspection at the border inspection post shall be carried out and of the EU Member State of destination. These Member States may allow other languages, if necessary, accompanied by an official translation.
Article 4 

1. The intermediate products imported into the Community shall be checked at the border inspection post of first entry in accordance with Article 4 of Directive 97/78/EC and transported directly from the border inspection post of entry into the Community either:
(a) to a technical plant approved in accordance with Article 18 of Regulation (EC) No 1774/2002, where the intermediate products shall be further mixed, used for coating, assembled, packaged or labelled before they are placed on the market or put into services in accordance with the Community legislation applicable to the final product; or
(b) to a Category 3 intermediate plant or storage plant approved in accordance with Article 10(3) or with Article 11 of Regulation (EC) No 1774/2002.
2. Intermediate products in transit through the Community shall be transported in accordance with Article 11 of Directive 97/78/EC.
3. The official veterinarian at the border inspection post concerned shall inform the authority in charge of the plant at the place of destination of the consignment via the TRACES system.
4. The outer packaging of intermediate products shall be labelled: ‘FOR MEDICAL DEVICES/IN VITRO DIAGNOSTICS/LABORATORY REAGENTS ONLY’.
Article 5 
The operator or owner of the plant of destination or his representative shall use and/or dispatch the intermediate products exclusively for the technical purposes specified in the approval of the plant, as referred to in point (a) of Article 4(1).
Article 6 
The operator or owner of the plant of destination or his representative shall keep records in accordance with Article 9(1) of Regulation (EC) No 1774/2002 and shall provide the competent authority on request with the necessary details of purchases, sales, uses, stocks and disposals of surplus of the intermediate products for the purposes of checking compliance with this Regulation.
Article 7 

1. The competent authority shall ensure, in accordance with Directive 97/78/EC, that the consignments of intermediate products are sent from the EU Member State in which the inspection at the border inspection post shall be carried out to the plant of destination, as referred to in Article 4(1) of this Regulation, or in the case of transit, to the post of exit.
2. The competent authority shall carry out documentary checks at regular intervals for the purpose of reconciliation of the quantities of intermediate products imported on the one hand, and stocked, used, dispatched or disposed of on the other, in order to check compliance with this Regulation.
3. For consignments of intermediate products in transit, the competent authorities responsible for the border inspection posts of entry and of exit respectively shall cooperate as necessary to ensure that effective checks are carried out and to ensure the traceability of such consignments.
Article 8 
Annexes VIII and X to Regulation (EC) No 1774/2002 are amended in accordance with Annex III to this Regulation.
Article 9 
This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.
It shall apply from 1 January 2007.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 22 December 2006.
For the Commission
Markos KYPRIANOU
Member of the Commission
ANNEX I
1. 

((a)) ensure that the plant has adequate facilities for the transformation of Category 3 material, to ensure the completion of the design, transformation and manufacturing stages referred to in Article 2;
((b)) establish and implement methods of monitoring and checking the critical control points on the basis of the process used;
((c)) keep a record of the information obtained pursuant to (b) for a period of at least two years for submission to the competent authority;
((d)) inform the competent authority if any available information reveals the existence of a serious animal health or public health hazard.

2. 

((a)) The frequency of inspections and supervision shall depend on the size of the plant, the type of products manufactured, risk assessment and guarantees offered, based on the principles of the system of HACCP.
((b)) If the inspection carried out by the competent authority reveals that the provisions of this Regulation are not being complied with, the competent authority shall take appropriate action.
((c)) The competent authority shall draw up a list of plants approved in accordance with this Regulation within its territory. It shall assign an official number to each plant, which identifies the plant with respect to the nature of its activities. The list and subsequent amendments shall be submitted to the EU Member State in which the inspection at the border inspection post shall be carried out and to the Member State of destination.

ANNEX II
I, the undersigned, declare that the intermediate products referred to above are intended to be imported by me into the Community and that:


1.. they are derived from Category 3 material referred to in Article 6 of Regulation (EC) No 1774/2002 and are intended for the manufacture of medical devices, in vitro diagnostics or laboratory reagents;
2.. their design, transformation and manufacturing stages have been sufficiently completed in order to be regarded as processed products and to qualify them for that purpose, except for the fact that they require some further handling or transformation such as mixing, coating, assembling, packaging or labelling to make them suitable for placing on the market or putting into service in accordance with the Community legislation applicable to the final products concerned;
3.. their outer packaging is labelled ‘FOR MEDICAL DEVICES/IN VITRO DIAGNOSTICS/LABORATORY REAGENTS ONLY’; and
4.. they will not be diverted at any stage within the Community for any use in food, feed material, organic fertilisers or soil improvers and will be conveyed directly to the following establishment:

 Name: …
 Address: …
The importer

 Name: …
 Address: …
Done at: …

 (place)
 (date)
Signature: …

ANNEX III

Annexes VIII and X to Regulation (EC) No 1774/2002 are amended as follows:

1.. Annex VIII is amended as follows:

((a)) the heading of Chapter IV is replaced by the following:
''
((b)) the heading of Chapter XI is replaced by the following:
''
2.. Annex X is amended as follows:

((a)) In Chapter 4(C), the heading of the Health certificate: ‘For blood products to be used for technical purposes, including pharmaceuticals, in vitro diagnostics and laboratory reagents, but excluding serum of equidae, intended for dispatch to the European Community’, is replaced by the following heading:
'For blood products, excluding serum of equidae and intermediate products as referred to in Article 1 of Commission Regulation (EC) No 2007/2006, to be used for technical purposes, intended for dispatch to the European Community.'
((b)) In Chapter 8, the heading of the Health certificates: ‘For animal by-products for the manufacture of technical products (including pharmaceutical products), intended for dispatch to the European Community’, is replaced by the following heading:
'For animal by-products to be used for technical purposes, intended for dispatch to the European Community'
