down in Council Directives 90//EEC and 93/42/EEC with respect to active and medical devices manufactured utilising tissues of animal origin Text with. Specific rules for medical devices manufactured utilising tissues of animal origin were initially adopted by.
Commission Directive /32/EC of. In support of this Directive, the Commission has recently issued revised regulations (/) regarding the use of TSE-relevant animal tissues and products.
Details about the responsibilities of manufacturers and authorized representatives can be found in the new legislative framework which covers all CE marking legislation.
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When caught in an infraction, the measures imposed on manufacturers may vary from a simple warning to a hefty fine or complete withdrawal from the market, depending on the type of infraction. The information must be evaluated for possible relevance to safety, especially in any of the following cases: a previously unrecognised hazards are identified; b the estimated risk arising from a hazard has changed or is no longer acceptable; c the original assessment is otherwise invalidated.
Tissues or derivatives of animal origin coming into contact with the patients and users The manufacturer must consider: a the maximum quantity of animal tissues or derivatives coming into contact with the patient or user when using a single medical device; b the contact area: its surface, type e. The AIMD directive has but one class and does not allow self-certification.
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|It is appropriate to lay down additional provisions on the use of such materials as starting tissue for the manufacture of medical devices.
Accept Refuse. CE marking: www.
An Introduction to Medical Device Legislation in the European Union
Nature of starting tissue The manufacturer must take into account the classification of the risks relating to different types of starting tissue as defined in the WHO Guidelines on Tissue Infectivity Distribution in Transmissible Spongiform Encephalopathiesas amended. Where appropriate, the animals shall be subjected to veterinary ante- and post-mortem inspection.
evaluate devices utilising animal tissues or derivatives, are appropriately. starting materials of animal origin that are used in the manufacture of such products. regulated under the Medical Device (MD) Directive.
(93/42/EEC) that are manufactured using animal tissue rendered nonviable or using nonviable products.
Animals as a source of material The TSE risk is related to the source species, strains and nature of the starting tissue. A justification for the use of animal tissues or derivatives in the medical device, including a rationale for the acceptability of the overall TSE risk estimate, the evaluation of alternative materials and the expected clinical benefit: The manufacturer must not source animal tissue or derivatives classified as potentially high TSE infective, unless sourcing of these materials is necessary in exceptional circumstances, taking into account the important benefit for the patient and the absence of an alternative starting tissue.
Information regarding —. Until 29 AugustMember States shall accept the placing on the market and the putting into service of active implantable medical devices referred to in Article 1 1 which are covered by an EC design-examination certificate or an EC type-examination certificate issued before 29 August
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The EU Regulation / on utilizing tissues of animal origin
Increase of the overall TSE risk. Risk assessment was addressed in guidance and standardization. An estimate of the TSE risk arising from the use of the product, taking into account the likelihood of contamination of the product, the nature and duration of patient exposure:.