Regulation EU (No) 722/2012 – New Regulation regarding medical devices utilizing tissues of animal origin

Enews - 27 March 2013

European Union Commission Regulation No 722/2012 concerning both active implantable medical devices (AIMD) and medical devices manufactured utilizing tissues of animal origin was originally published in the Official Journal of the European Union on 9th August 2012. The changes will apply from 29th August 2013. The Regulation replaces the existing requirements of directive 2003/32/EC and applies to both the AIMD and Medical Device Directives (90/385/EEC and 93/42/EEC respectively).