Agreement Reached on EU Medical Device Regulation

The parties involved in negotiating the new Medical Device Regulation have reached agreement on the issues. The EU published a press release in May 25, 2016 announcing the result. The agreement includes the regulation for in vitro diagnostic devices.

The next steps include formal adoption by European Council and the Parliament. The Medical Device Regulation goes into three years after publication and the In Vitro Diagnostic Device Regulation goes into effect five years after publication. The text of the agreed regulation is not yet available. The press release discusses some of the extensive changes.