EU Reclassification Directive: adoption by Commissioners before end of July?
This article was originally published in Clinica
Executive Summary
As Clinica went to press, there was speculation that the European Directive on the reclassification of joint implants, namely hip shoulders and knees, was due to be finally adopted by the EU's College of Commissioners on July 27. Publication in the Official Journal of the European Union will follow, after which member states will have six months to transpose it into their national law. There will then be a transition period of 18 months by the end of which manufacturers will have to comply with the new rules and submit their design dossiers for notified body review.