Animal Tissue Products
This article was originally published in RAJ Devices
Executive Summary
European directive deadline extended
European directive deadline extended
European Union (EU) member states have agreed to be flexible over the deadline for compliance with the EU directive on medical devices containing animal tissue (Directive 2003/32/EC) 1,2. At the European Commission's Medical Devices Experts Group (MDEG) meeting on 14 December 2004, member states agreed to continue to allow devices that are already on the market and which are not fully in compliance with the new directive to remain on sale until 30 April 2005, if the product was approved before 1 April 2004 and placed on the market before 30 September 2004.
Under the directive, all devices manufactured utilising animal tissues were required to obtain notified body certification demonstrating their compliance with the directive by September 2004. However, some member states had failed to designate notified bodies competent to assess industry's submissions, making the deadline unachievable to manufacturers. MDEG therefore agreed to a request from the commission that the devices in question can continue to be placed on the market while awaiting completion of the procedure required under the directive as long as they hold an EC design-examination certificate or EU type-examination certificate issued prior to 1 April 2004.
References
1. Thierry Chignon, Quintiles Consulting, IIR conference on drug, device and biologics combination products, 14-15 December 2004
2. 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, OJ, L105, 20
3. The Regulatory Affairs Journal - Devices, 2003, 12(6), 359-360