Commission Directive 2003/32/EC (repealed)Dangos y teitl llawn

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(Text with EEA relevance) (repealed)

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 medical devices must meet pursuant to that Directive. Points 8.1 and 8.2 of that Annex set out specific requirements intended to eliminate or reduce as far as possible the risk of infection for the patient, user and third parties due to tissues of animal origin and specifies that the solutions adopted by the manufacturer in the design and construction of the devices must conform to safety principles taking into account the generally acknowledged state of the art.

(12) With regard to medical devices manufactured utilising tissues of animal origin it is necessary to adopt more detailed specifications in relation to the requirements of point 8.2 of Annex I to Directive 93/42/EEC and to specify certain aspects relating to the risk analysis and risk management in the framework of the conformity assessment procedures referred to in Article 11 of that Directive.

(13) Some of the terms used in Directive 93/42/EEC should be further clarified in order to ensure a uniform implementation of this Directive.

(14) It is necessary to provide for an adequate transitional period for medical devices already covered by an EC design-examination certificate or by an EC type examination certificate.

(15) The measures provided for in this Directive are in accordance with the opinion of the Committee on Medical Devices set up by Article 6(2) of Council Directive 90/385/EEC(4),

HAS ADOPTED THIS DIRECTIVE:

(1)

OJ L 169, 12.7.1993, p. 1.

(2)

OJ L 6, 10.1.2002, p. 50.

(3)

OJ L 273, 10.10.2002, p. 1.

(4)

OJ L 189, 20.7.1990, p. 17.