MDR update: where are we now?

Our last post with MDR updates dates already from March. At that moment the European Commission announced that the application date of the MDR was postponed with one year.

Since that time, the world has been busy coping with the COVID-19 crisis. But also in the background, manufacturers are continuing their efforts for getting ready to comply to the MDR.

In this post, we'd like to give you an update on what has changed in the past 6 months in terms of updates from the European Commission.

Timelines: Date of Application of the MDR is 26th of May 2021

Early April, the proposal to postpone the Date of Application of the MDR by one year was submitted and this was 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: Actor registration as of December 1st 2020

Eudamed, the European Databank on Medical Devices, is one of the pillars of the MDR. It will contain information on Actors (e.g. manufacturer, authorized representative), devices (including certificates and UDI), incidents, clinical investigations, ...

As we mentioned last November, there is a delay in the  implementation of EUDAMED till 2022. This has been fine tuned by the MDCG 2020-15 position paper.

Even though indeed the full functionality of all six modules of EUDAMED is still foreseen by 2022, the "Actor Registration" module should be active by December 1st 2020. This module allows all Actors such as manufacturers, authorized representatives and importers to request a Single Registration Number (SRN). The responsibility of assigning SRNs will be with the different Member States. The SRNs are referenced in the MDR and should e.g. appear on certificates.

Notified Bodies: Things are moving (slowly)

In the past 6 months, 4 more Notified Bodies have reached the end and have been published on the Nando website. The counter is on 16.

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)

• DQS Germany (NB0297)

• GMED France (NB0459)

• IMQ Italy (NB0051)

• Intertek Sweden (NB2862)

• MDC Germany (NB0483)

• 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 now 4 - one more than 6 months ago. More information can be found on the Nando website:

• BSI UK (NB0086)

• BSI Netherlands (NB2797)

• DEKRA Germany (NB0124)

• TUV SUD Germany (NB0123)

Harmonized Standards: List of standards to be harmonized under the MDR published

In May 2020, the European Commission published an implementing decision related to standards to be harmonized under the MDR and IVDR.

The proposed list in this communication contains 57 existing standards that need to be revised before harmonization under the MDR and 6 new standards to be drafted (with proposed adoption dates in 2024).

Knowing that currently, the list of harmonized standards contains 264 standards, it is indeed a reduced number. It seems that there is more focus on general standards, rather than product specific standards when it comes to harmonization.

For the IVDR, 39 existing standards need to be revised and 4 new standards need to be drafted.

We advise you to monitor the status of harmonization of these standards. 

When we receive new updates, we'll keep you posted in the next article!