Directive 2003/32 - Detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin - Main contents

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Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin (Text with EEA relevance)

Official Journal L 105 , 26/04/2003 P. 0018 - 0023

Commission Directive 2003/32/EC

of 23 April 2003

introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 93/42/EEC of 14 June 1993 concerning medical devices(1), as last amended by Directive 2001/104/EC of the European Parliament and of the Council(2), and in particular Article 14(b) thereof,

Whereas:

• (1) 

  On 5 March 2001 France adopted a national measure prohibiting the manufacture, placing on the market, distribution, import, export and use of medical devices manufactured from materials of animal origin, where these are used as dura mater substitutes.

• (2) 

  France justified the measure by the uncertainties that exist with regard to the risk of transmission to humans of animal spongiform encephalopathies from such medical devices, and by the fact that alternatives are available, in the form of synthetic materials or autologous materials taken from the patient.

• (3) 

  Other Member States have taken unilateral national measures on other legal bases in relation to the use of certain raw materials originating from animal tissues and presenting specific risks of transmitting animal spongiform encephalopathies.

• (4) 

  All those national measures are related to the general protection of public health against the risks of transmitting the animal spongiform encephalopathies via medical devices.

• (5) 

  With regard to the sourcing of materials used in medical devices the provisions set out in Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption(3) apply.

• (6) 

  In order to improve the level of safety and health protection, it is necessary to further reinforce the protective measures against the overall risk of transmitting animal spongiform encephalopathies via medical devices.

• (7) 

  The Scientific Committee on Medicinal Products and Medical Devices has adopted an opinion on the use of Transmissible Spongiform Encephalopathies (TSE) risk materials for the manufacture of implantable medical devices, which recommends that manufacturers of these devices that utilise animal tissues or derivatives be required, as an essential part of the risk management, to fully justify the use of these tissues in the context of the benefits to patients and of the comparison with alternative materials.

• (8) 

  The Scientific Steering Committee has adopted several opinions on specified risk materials and on the products derived from ruminant tissues, such as gelatine and collagen, which are of direct relevance to the safety of medical devices.

• (9) 

  Medical devices manufactured utilising non-viable animal tissues or derivatives rendered non-viable are Class III devices in accordance with the classification rules set out in Annex IX to Directive 93/42/EEC, except where such devices are intended to come into contact with intact skin only.

• (10) 

  Prior to being placed on the market, medical devices, whether they originate in the Community or are imported from third countries, are subject to the conformity assessment procedures laid down in Directive 93/42/EEC.

• (11) 

  Annex I to Directive 93/42/EEC sets out the essential requirements that...

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