Update on Commission reaction to ENVI resolution – no PMA proposal on the table

In my previous post on this topic I wrote that it looked like the Commission had changed tack to propose a pre-market authorisation (PMA) for medical devices after all. It turns out that I had drawn that conclusion prematurely. This post serves to update and correct the picture. As more information became available after the hearing in which Commissioner Dalli addressed the European Parliament it seems that the Commission has not changed course on the point of PMA. Commissioner Dalli was paraphrased to hav [...] « Read the rest of this article on medicaldeviceslegal »