2003/32/EC - Animal Tissue TSE Species CE Marking

Medical devices utilizing certain tissues of animal origin are covered by EC Directive 2003/32/EC as well as EC Directive 93/42/EEC, and CE marking requires certification to both directives. SGS offers this service through its combined Annex II assessments.

Medical devices containing animal tissue of Transmissible Spongiform Encephalopathy (TSE) prone species (cow, sheep, goat, deer, elk, mink, and cat) or material derived from such tissue are subject to the requirements of both directives and conformance to the following standards must be demonstrated:

• EN ISO 22442-1:2007 - Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
• EN ISO 22442-2:2007 - Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling
• EN ISO 22442-3:2007 - Medical devices utilizing animal tissues and their derivatives Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents

Without an EDQM (European Directorate for the Quality of Medicines and Healthcare) certificate for the animal tissue or substance, we are also obliged to enter a consultation process with the EC Competent Authorities on the risk/benefit of using the animal tissue or derivative in this device.

Medical devices containing such material are considered by the Competent Authorities in Europe as automatically being of the highest risk. To achieve certification which includes the animal tissue directive it is important to work with an audit partner such as SGS who is experienced in animal tissue assessments and can advise you on the documentation required to demonstrate a positive benefit-to-risk ratio. Our global network of offices ensures that wherever your operation is based, certification can be achieved.

Contact SGS to achieve your organization’s certification against 93/42/EEC and 2003/32/EC.

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