FDAnews Device Daily Bulletin

EU Issues New Rules on Devices, AIMDs Using Animal Tissues

Sept. 10, 2012
The EU last month published its much-anticipated regulation on medical devices and active implantable devices that use tissues of animal origin, but any impact on devicemakers is expected to be minimal, experts say. Most of what is contained in Commission Regulation 722/2012, which updates a 2003 directive on transmissible spongiform encephalopathies, was already prescribed in EU guidance on TSE, Erik Vollebregt, a device law attorney with Axon Advocaten in the Netherlands, said.
International Medical Device Regulatory Monitor