EU Medical Devices Regulation Upcoming Release

The European Commission has made an agreement on the Medical Devices Regulation.

The regulation will be published in the coming months; a preview has been created for medical device professionals to warm up to until the final pages have been inked.

Comprised of around 100 provisions and extensive annexes, topic issues that will be covered in the regulation are: transitional periods; scope; notified bodies; transparency; liability of authorized representatives; and traceability and postmarket oversight. — Cynthia Jessup