Tissues of Animal Origin Directive (2003/32/EEC)

Providing access to the European market

Manufacturers of medical devices that use tissues of animal origin should be aware that such tissue is only allowed on the European market if it complies with the Tissues of Animal Origin Directive (2003/32/EEC) in combination with the Medical Device Directive.

To ensure access of medical devices to the European Union and associated countries (EEA), DEKRA provides CE certification under the Medical Device Directive, the Active Implantable Medical Device Directive and the In-Vitro Diagnostic Medical Device Directive. We cover the full scope under these directives, including medical devices containing material of animal origin and material originating from human blood.
DEKRA is a one-stop shop for medical device manufacturers.
Consider these advantages:
  • Global presence
  • All testing and certificates provided by a single organisation. In addition to the IVDD Directive, we also provide certification for MDD, 510(k) reviews and ISO 13485 certification.
  • We are specialists with extensive experience in the medical industry
  • We have developed a special programme that helps you into market
  • If you are dissatisfied with the service you receive from your current Notified Body, we have experience in assuming certificates