premarket authorisation


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

In my previous post on this topicĀ 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…


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…

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