EU animal tissue rule enforcement threatens existing products
This article was originally published in Clinica
Executive Summary
There is a risk that a large number of medical device companies will be forced to remove from the EU market on September 30 products that have been manufactured utilising animal tissues. It seems that the deadline for meeting the EU Directive 2003/32/EC, introducing detailed specifications for such products within the context of the Medical Devices Directive, is not going to be tenable for the 200 or so products that will need to comply.