Written by Joe Hage in the MedicalDevicesGroup on LinkedIn
You know that nice, little Medical Device Directive (the MDD) you've been using for 20 years to get a CE mark?
You know it's going away, right? Zero MDD certificates will be issued after May 25, 2020.
And since CE marks need renewing every five years, by May 2025, everyone doing business in the European Union will have transitioned to the new way of getting their CE mark.
The new sheriff in town.
The Medical Device Regulation (MDR) is the new sheriff in town. He may be new, but he's bigger and badder than his predecessor.
You're going to have to jump through some serious hoops to get your coveted CE mark.
Or should I say, your notified body is going to have serious hoops to help you get your CE mark. Is your notified body (NB) up to the task?
Are you in bed with the right partner?
Mark Schmark – How hard can it be?
I ignorantly thought, "Any NB worth its salt should be able to give a CE mark. Under this Directive, under that Regulation, whatever."
A CE mark is the basic requirement for marketing and selling medical devices in Europe.
I mean, if a notified body can't even give a CE mark for someone, how could they even be...
