MDR - Ready, Steady, GO? - Update 2
We are now roughly 6 months before the end of the transition period (26 May 2020) of the new European Medical Device Regulation (2017/745) that was published in May 2017.
So here is a new status update:
Timelines: Class I devices that will be up-classified will have a longer transition time
The first change in planned timelines is a fact: on December 3rd, the European Parliament adopted the second corrigendum of the Medical Devices Regulation (page 44 for English).
Article 120.3 will now become:
By way of derogation from Article 5 of this Regulation, a device which is a class I device pursuant to Directive 93/42/EEC, for which the declaration of conformity was drawn up prior to 26 May 2020 and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, or which has a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and that is valid by virtue of paragraph 2 of this Article, may be placed on the market or put into service until 26 May 2024, provided that from 26 May 2020 it continues to comply with either of those Directives, and provided there are no significant changes in the design and intended purpose. However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives.'.
Please note that there is still the possibility that Members of the Parliament will ask for a plenary vote that might change or undo the implementation of these changes.
So basically, current class I devices that will be up-classified under the MDR, will not have to be certified under the new Regulation from May 26th 2020 on. Instead, they can rely on the Declaration of Conformity that was drawn up under the MDD until May 25th 2024. However, there cannot be any significant changes in design or intended purpose.
Manufacturers of class I (not custom-made) devices that will be up-classified, can use this time to build their Technical Files and collect more clinical and PMS data.
However, 2024 will probably be quite busy for Notified Bodies as well as some manufacturers might plan the transition of (part of) their portfolio at that time.
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: still a bottleneck
As mentioned before, the MDR doesn't only impact the manufacturers but also the Notified Bodies. There are 57 Notified Bodies for the MDD, however, only 7 have been accredited for the MDR (based on the Nando website):
BSI UK (NB0086)
BSI Netherlands (NB 2797)
DARE!! Services Netherlands (NB 1912) - new player
DEKRA Germany (NB0124)
IMQ Italy (NB0051)
TUV Rheinland Germany (NB0197)
TUV SUD Germany (NB0123)
As we said in our last update, we can only hope that there are more in the final stage of obtaining their accreditation.
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 MDR, the number of accredited Notified Bodies went from 5 to 7 since our last update. 7 is better than 5 but still far from enough to cover the whole Medical Device industry efficiently. Let's hope that number will go up pretty soon!
For the Notified Bodies accredited for IVDR, they are still only 2. More information can be found on the Nando website:
BSI UK (NB0086)
DEKRA Germany (NB0124)
Harmonized Standards: no changes to be reported
With only 6 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.