MDR - News from Europe regarding Notified Bodies

4 months to go before the end of the transition period (26 May 2020) of the new European Medical Device Regulation (2017/745) which was published in May 2017.

So here is a new status update:

Timelines: no updates

In our last blog article regarding this topic, we reported on the changes for class I manufacturers. No further news on this end.

Eudamed: launch postponed - no further update

As we mentioned last November, there is a delay in the  implementation of EUDAMED and we don't expect an update on that very soon.

Notified Bodies: Things are moving (slowly)

On January 21st 2020, the European Commission published an updated state-of-play regarding the status of Notified Bodies and their accreditation for MDR and IVDR

• 86% of the current Notified Bodies for medical devices are in the process of applying for MDR designation

• 50% of the current Notified Bodies for in-vitro diagnostic devices are in the process of applying for IVDR designation

This is the current situation (figure taken from publication by the European Commission):

As you can see, there are indeed some Notified Bodies that are approaching the end of the process.

Compared to our previous article, 3 more have reached the end and have been published on the Nando website. The counter is on 10.

Notified Bodies accredited for the 2017/745 MDR:

• BSI UK (NB0086)

• BSI Netherlands (NB2797)

• DARE!! Services Netherlands (NB 1912) - new player

• DEKRA Germany (NB0124)

• DEKRA Netherlands (NB0344)

• DNV GL Presage AS Norway (NB2460)

• IMQ Italy (NB0051)

• Medcert Germany (NB0482)

• TUV Rheinland Germany (NB0197)

• TUV SUD Germany (NB0123)

We advise you to keep monitoring the Nando website, keep close contact with your current Notified Body and also understand if they will still be able to certify your product.

For the Notified Bodies accredited for IVDR, there are now 3. More information can be found on the Nando website:

• BSI UK (NB0086)

• BSI Netherlands (NB2797)

• DEKRA Germany (NB0124)

Harmonized Standards: no changes to be reported

With only 4 months left before the end of the transition period, we have still no word from Europe about Harmonized Standards. If anything changes, we'll let you know.