Switch language

MDR Update: Proposal to postpone Date of Application MDR

26-Mar-2020 - Ann Vankrunkelsven

It's been one month since we published our latest update on the evolution regarding MDR implementation. And the work was progressing slowly and silently.

However, on March 25th 2020, there was an announcement from the European Commision where they say that they are working on postponing the application date for the MDR by one year.

Looking at the situation, of both the companies within the medical device field, the accreditation status of Notified Bodies and the readiness of Europe itself, it's something we've been waiting for.

 

So here is a new status update:

Timelines: Proposal for delaying Date of Application by one year

The Commission plans to submit a proposal early April to the Parliament and the Council to postpone the Date of Application of the MDR by one year. This means that for MDR, the end of the transition period would be shifted with one year.

The official date is yet to be announced once the approval will be accepted and approved. It's important to note that this is a careful announcement. This proposal still needs to be approved.

Note that this announcement only mentions MDR, not IVDR.

Impact on Switzerland and Turkey

We posted an article on the uncertainty regarding Swiss manufacturers before. If the deadline for the date of application of the MDR is postponed, it would mean that there is indeed as well more time for Switzerland and Turkey to establish updated Mutual Recognition Agreements with Europe that refer to the new legislation.

Regarding Brexit, nothing changes as the UK will leave the Union by end of 2020.

Eudamed: launch postponed - no further update

As we mentioned last November, there is a delay in the  implementation of EUDAMED till 2022 and we don't expect an update on that very soon.

Notified Bodies: Things are moving (slowly)

Compared to our previous article, 2 more have reached the end and have been published on the Nando website. The counter is on 12.

Notified Bodies accredited for the 2017/745 MDR:

  • BSI UK (NB0086)
  • BSI Netherlands (NB2797)
  • CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft. Hungary (NB2409)
  • DARE!! Services Netherlands (NB 1912)
  • DEKRA Germany (NB0124)
  • DEKRA Netherlands (NB0344)
  • DNV GL Presage AS Norway (NB2460)
  • IMQ Italy (NB0051)
  • Medcert Germany (NB0482)
  • National Standards Authority of Ireland (NSAI) (NB0050)
  • 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 still 3 - nothing changed. 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

We have still no word from Europe about Harmonized Standards. If anything changes, we'll let you know.

© 2020 All rights are reserved, v Manage cookies on this site Legal / Impressum