Episode 33 – Notified Bodies Lay Down Service with Erik Vollebregt

Medical Device made Easy Podcast · Jul 22, 2019

► Webpage: https://podcast.easymedicaldevice.com/33

As we are changing the Medical Device rules, we need to certify new Notified Bodies in Europe. With the new MDR 2017/745 and IVDR 2017/746, all Notified Body should apply for new accreditation.

But apparently, this new regulation is not so easy and many Notified Bodies decided to not apply first. Then we have Notified Bodies that applied but decided to Lay Down Service (LRQA, UL, Intertek, QS Zurich…).

So what are the consequences for Manufacturers that have a certificate with these Notified Bodies?

What should they do to continue the…