It’s official: the ENVI resolution is out in final version – EU Commission changes tack to propose PMA for devices

Some time ago I wrote about the proposed ENVI resolution that the the EU Parliament’s ENVI committee adopted in reaction to the PIP breast implants scandal in the EU. At that time the final text was not out because the EU Parliament still had to vote on it. Now it has and the adopted resolution does not differ very much from what we expected based on the ENVI Committee’s press release, so I won’t repeat myself in any detail. As I wrote, the Parliament has given the Commission a shot acros [...] « Read the rest of this article on medicaldeviceslegal »