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Medical devices utilizing certain tissues of animal origin are covered by Commission Regulation N° 722/2012 as well as EC Directive 93/42/EEC and CE marking requires certification to both. In addition, CE marking will soon require certification to MDR (EU) 2017/745.

Cargo and truck at harbour

We provide certification with combined Annex II assessments under EC Directive 93/42/EEC or Annex IX or Annex XI part A under MDR (EU) 2017/745.

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 these directives and conformance to the following standards:

  • EN ISO 22442-1:2015: Medical devices utilizing animal tissues and their derivatives – Part 1: application of risk management
  • EN ISO 22442-2:2015: 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

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.

Contact us today to achieve your organization’s certification against 93/42/EEC or MDR (EU) 2017/745 and Regulation (EU) 722/2012.