Swixit, Turxit and Brexit
There is also the Swiss situation, where the AIMDD and MDD are supported by an existing Mutual Recognition Agreement (MRA), while the MDR is still lacking a signed MRA. This means that from the perspective of the MDR, Switzerland becomes a Third Country and Swiss manufacturers need an Authorized Representative and importer. In addition to that, Article 120(1) de-designates AIMDD- and MDD-designated NBs from May 26th. This requires all current Swiss certificates to be moved to EU 27 NBs, which may be a bit of a challenge right now.
Expert panels
About 700 applications for the Expert Panels have been submitted. Selection is expected to be finalized before May 26th, 2020. There are uncertainties regarding the volume of work, so it is proposed to start with involving the Expert Panels in the clinical/performance evaluation consultation procedures first and then phase in other functions.
Implementing acts
Implementing acts may or may not be ready before the Date of Application. Many of these acts are crucial for devices that need to be certified under the MDR by May 26th. For example, the CNE/CENELEC harmonization request is not formalized, and that would only mark the start of the harmonization process. This means manufacturers are not given enough time, or no time at all, to apply harmonized standards for their conformity assessment.
MDCG does not provide, or promise to provide, guidance on this. Manufacturers should therefore determine which standards they consider representing the state of the art in medical science and technology in relation to their devices, and lay that down in a rationale as part of their technical documentation.
Monitoring
Industry and NBs are asked to report on progress of the implementation of the MDR, because that may identify potential problems early and find adequate solutions. Commission Services will ask for those updates, but it is not clear how those updates will be compiled and further processed in practice. The continued availability of medical devices on the European market appears to be leading. There is an interesting promise made: “Commission Services will make available adequate mechanisms to communicate and coordinate activities among Member States and with stakeholders.” If this is intended to safeguard the availability of medical devices, this could be about Article 59 that allows for authorization by a Competent Authority for putting devices on the market for which the conformity assessment procedure has not been carried out.
This may sound like a handy fallback for devices that have missed out on MDR certification. But the two big questions are, of course, how well the system can cope with large numbers of Article 59 requests and how the authorities can communicate about this without the availability of Eudamed. Eudamed would have provided a clear single point of formal information; something needs to be set up to ensure it is clear which non-CE marked devices can be safely used, and which are to be avoided. Especially under the current conditions, this is going to be a challenge.
Conclusion
The Date of Application of the MDR, Brexit, Swixit and now complications stemming from the COVID-19 pandemic are whipping up what had already been seen as a very complex and ambitious exercise into a perfect storm of complexity. The Joint Implementation/preparedness plan does not provide major new insights to untangle this immense knot. It mainly confirms what has already been communicated by others: the MDR implementation is not running according to plan.
It appears that, unless European citizens are willing to accept unpredictable disruptions in the continuity of their care due to devices not being available, the current timelines for the implementation of the MDR need to move significantly.
Related European MDR resources available from Emergo by UL:
- EU MDR compliance preparation and resource center
- European Authorized Representative in-country representation
- Whitepaper: Understanding Europe’s new Medical Devices Regulation
- Webinar: Eudamed requirements under the EU MDR and IVDR