COCIR: COCIR Publishes its High-Level Contribution on Medical Device Regulation

The future of medical device regulation in Europe will continue to be a pressing debate in 2013 as the European Commission’s 2012 proposal moves through the EU institutions (European Council and European Parliament) for further consideration.

COCIR* continues to actively contribute as such future regulation could potentially have a significant impact on their technologies and their ability to continue to provide highly-innovative products and services that save lives of citizens every day globally.

The COCIR paper touches on the benefits of a Regulation versus a Directive, considers the regulatory compliance costs at a time of economic crisis and examines the role of the EU Notified Bodies. This paper also sets out six key matters of concern to COCIR related to the current proposed regulation.

“At a time when all are being asked to do more with less, we would like to give a sense of caution to the EU institutions so that they can ensure that current regulations are properly enforced, with a focus on post-market surveillance and that future regulations can continue to boost and support innovation while maintaining the highest level of safety for citizens and ensuring support of our healthcare and ICT-related technologies,” said COCIR Secretary General Nicole Denjoy.

Download here COCIR contribution