A few weeks ago, we published a blog post regarding the status of the MDR. As expected, things are still changing and now it's time for a first update!
In May 2017, the new European Medical Device Regulation (2017/745) was published. It has a 3 year transition period which ends in May 2020.
The change from the MDD to the MDR is a big change. This is not a matter of commas here or there, it's much more than that.
These changes have an impact on which devices will be considered as medical devices, their classification, documentation and testing. They will also impact responsibilities of economic operators (manufacturers, authorized representatives, importers and distributors) etc.
For device developers and economic operators the changes are significant. Also for the Notified Bodies, the change in legislation has a major impact.
At the time of publication of this post, we are roughly 7 months before the end of the transition period of the MDR. We would like to give a status update on 4 topics:
- Notified Bodies
- Harmonized Standards
The official end of the transition period for the MDR is 26th of May 2020.
The European Commission has published an Infographic Timeline.
This is still the confirmed date according to the latest communication from the European Commission.
Currently, EUDAMED is a secure web-based portal, only available for competent authorities and the European Commission. It is a central database for market surveillance information which is aimed at enhancing the communication between different national competent authorities. It is not publically accessible.
However, under the MDR, the goal of EUDAMED is broader: It will hold information on economic operators, UDI and devices, Notified Bodies and certificates, vigilance, clinical investigations and market surveillance. Part of it will be open for public consultation.
It was the aim to have EUDAMED live by early 2020 and fed with all required information by the end of the transition time. From the start, this was a very challenging task and already for some time there were rumours that this deadline would be postponed.Now, the European Commission has indeed updated their explanation of when EUDAMED should go live. On their website, you can read the following:
The Commission concluded that it will only be possible to make EUDAMED operational once the entire system and its different modules have achieved full functionality and have been subject to an independent audit. Therefore EUDAMED’s launch will be done together for medical and in-vitro medical devices, at the original date foreseen for in-vitro medical devices i.e. May 2022.
This means that the launch of EUDAMED has been postponed by two years.
As mentioned before, the MDR doesn't only increase the pressure on manufacturers of medical devices, also for the Notified Bodies this is a huge burden. It was expected that some of the Notified Bodies would not apply for accreditation under the MDR due to increased requirements. However, at this point in time, only 5 Notified Bodies have actually obtained their accreditation for the MDR (based on the Nando website):
- BSI UK (NB0086)
- DEKRA Germany (NB0124)
- IMQ Italy (NB0051)
- TUV Rheinland Germany (NB0197)
- TUV SUD Germany (NB0123)
Knowing that currently 57 Notified Bodies appear on the Nando list, we can only hope that there are more in the final stage of obtaining their accreditation. In this regard, it's very important to monitor the Nando website, keep close contact with your current Notified Body and also understand if (assuming they will be accredited for MDR) they will still be able to certify your product.
For now, no changes on this end. For the Notified Bodies accredited for IVDR, the list was recently doubled. They went from 1 to 2 accredited Notified Bodies. More information can be found on the Nando website:
- BSI UK (NB0086)
- DEKRA Germany (NB0124)
Harmonized standards give presumption of conformity to the Essential Requirements of the MDD. However, so far there have not been any harmonized standards published for the MDR.
The MDR also provides the possibility to publish "Common Specification". These can provide additional requirements whenever the European Commission finds it necessary (e.g. in case there are no harmonized standards or when there are safety concerns for users). It is the task of the Medical Device Coordination Group (MDCG) to establish these Common Specifications. Again it is not clear yet when we can expect the first CS to be published.
Also here, there are no changes to be reported yet.
The first big change in the planning is the (expected?) delay of the launch of EUDAMED. Hopefully soon, we'll see the number of accredited Notified Bodies increase.
We will try to keep you updated but keep a close eye.