Mar 18, 2020
On March 13th, 2020, the European Medical Device Coordinating Group (MDCG) published the Joint Implementation/preparedness plan on the new Medical Devices Regulation (EU) 2017/745 (MDR). This plan has been drawn up by the European Commission together with the Member States, but it calls on all stakeholders involved to further step up their efforts and work together to achieve an operational system by May 2020. This plan aims at setting priorities and providing means to do so.
This plan has been drafted after calls from the European Council on December 9th, 2019, where health ministers requested a readiness check, and as result of the MDCG meeting of December 13th, 2019, where MDCG members wanted to see a list of key priorities that need to be finalized by May 2020. The priorities have been based on the interests of:
Of course other plans have been made to set priorities. On November 7th, 2017 CAMD published their roadmap for the implementation of the MDR and IVDR. This plan has been followed up by various documents, like for example the open letter on Eudamed from November 11th, 2019. The European Commission has its rolling plan in which priorities and achievements are brought together, and European Commissioner Elżbieta Bieńkowska informed in October 2019 the European Parliament about the progress of the MDR; the first Notified Body (NB) would designated before January 1st, 2019, Eudamed was not delayed and the implementation of the MDR would be carried out as planned. Time has shown that the first two statements were not justified. Considering the joint action plan it appears the third is now heavily challenged.
Eudamed has been delayed, but parts of the database have been developed and could have already been rolled out. The existing proposal is to have Eudamed’s actor module deployed from May 26th, 2020, and the other modules rolled out in a gradual manner thereafter. An MDCG position paper is under preparation regarding the Single Registration Number (SRN) and to encourage a common approach between Member States for recording actor’s data.
Also, MDCG-endorsed guidance is expected before May 26th regarding the absence of Eudamed and a list of information that will be available once Eudamed is fully functional. The European Commission should provide regular updates regarding the progress of Eudamed, as well as setting up a special MDCG sub-group on Eudamed.
It appears that the European Commission and MDCG are working towards a stepped introduction of Eudamed, which is not in line with the requirement of having Eudamed fully functional first, have it audited, and then publish a notice in the OJEU from Article 34. It is not clear how the stepped introduction will be achieved in relation to the audit and formal publication.
MDCG acknowledges there is a risk of devices not being available on the EU market due to both lack of certification and manufacturers cutting their product portfolio. However, MDCG indicate they do not know how big this problem this because of lack of data.
Of course each device has its own use profile, which defines its impact on continuity of care in case the product is not available. This makes it very difficult to fully understand the impact of limited availability of devices. Currently 11 NBs designated for the MDR, including one in the UK. In the joint plan these are called “a dozen,” which appears to reflect an optimistic attitude. This should be compared to the current 56 NBs under the MDD. At this moment manufacturers are urging their NBs to renew their current AIMDD and MDD CE certificates. The underlying presumption for this is that those NBs will be able to keep monitoring the current certificates. This strategy is impacted by the COVID-19 virus that has stopped on-site audits. Therefore there is an increased risk that AIMDD or MDD certificates are not followed up in time by MDR certificates.
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.
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 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.
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.
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.