The public part of the Employment, Social Policy, Health and Consumer Affairs Council meeting on last Monday, 9 December 2019 gave an interesting peek into how the Commission and the Council see the state of affairs with the MDR and IVDR implementation at the moment, and notably as well the delay of Eudamed implementation. The Commission was asked to provide an update of affairs to the Council, which was visibly ruffled and concerned about how the implementation of the MDR and IVDR were progressing. If you’re interested, you can watch it via this link.
So what’s the news? In case you are not curious enough to sit through the whole meeting, here is my summary.
Commission: ‘it will be bumpy’
The Commission, represented by the commissioner for health Stella Kyriakides herself, started off by mentioning the 20 notified bodies that it had been promising for this year actually turn out to be 12, which will include the double counted ones for the IVDR (that’s not what the Commission said, but that it how the Commission has been counting them so far). This means three additional notified bodies this year, but no mentioning of the way this works with the double count. I suspect that Dekra Netherlands is in the pipeline and one of these three. Rumor has it that NSAI may be another one. The other one could well an IVDR notified body. But, the Commission said, we will have 20 notified bodies by Q1 2020. By now I am quite tempted to say that seeing is believing.
The Commission further announced that Eudamed’s delay did not mean that the MDR will be delayed, like I mentioned already. If you did not believe me so far, maybe you will believe the Commission. If you believed the Commission when they said it would be 20 notified bodies this year – wait a second…. anyway. The Commission mentioned that it has started on the operational details of non-Eudamed information exchange as required under the MDR when Eudamed is not ready for some reason of the other, just as the ‘what if Eudamed is not ready’ regime in the MDR prescribes. So, the ‘Eudamed without Eudamed structure’, if you will, is under construction as we speak and there seems to be a central plan behind it. This is tentative good news in an otherwise not so good situation.
But, the Commission is looking into making the actor registration module available to the market on a voluntary basis by May 2020, seemingly in an attempt to help the market prepare for Eudamed going fully live at some point. This would seem to allow the economic actors to register themselves on a voluntary basis, but not yet their devices (because that is another Eudamed module).
After all the Member States had spoken as Council members (see below) the Commission finished by stating that the MDR was happening by end of May – Eudamed not being available was foreseen, so the MDR could go ahead without alternative plan. So, for the people that still do not believe it: no delay of the MDR. The Commissioner repeated this commitment in the press conference afterwards, and made the epic understatement that it would be a bumpy road to end of May 2020. I’m sure we all agree with this.
Council: ‘speed this thing up’
The Member States in the Council seemed somewhat exasperated and mostly echoed Sweden and Ireland in that the Commission should really intensify its efforts, provide a readiness check early 2020 and set up a dedicated MDCG group to deal with this and keep the Member States informed better. Clearly the Member States are not very happy with the way things are going although this was not what they admitted during the press conference afterwards. In the press conference afterwards the Finnish Presidency did not answer the question of a journalist who asked what the readiness check would look like. The Commissioner did not commit to this either and just said the Commission would keep the Member States informed.
Almost every Member State expressed concerns about the Eudamed delay, and here it was also interesting what was mostly not said and what the German delegate did say: Member States are worried about the level at which the Commission is doing Eudamed by itself and does not involve them to the level they would like. This confirms what I have heard earlier: that the Eudamed delay was also a surprise for the Member States because they were not that well informed. Some Member States (Hungary and Estonia) stated how this interfered with their national implementation process.
Other Member States stated other concerns that you would expect: why are there not enough notified bodies, why are the implementing acts still not there, where are the Common Specifications for reprocessing and Annex XVI devices.
The Netherlands, pragmatic as always, was advocating that parts of Eudamed should be adopted immediately when they were ready. Pragmatic, sure – but not how the MDR works. So those modules could, at best, be made available on a voluntary basis because still nobody want to re-open the legislative procedure for actual changes to the MDR. It would be a possible help for the companies that otherwise would need to find a way to be able to store and make available later into Eudamed two years worth of MDR related data and reports.
As the Commissioner said in the press conference: it will be a bumpy road. Let’s just hope it gets us there.
Great stuff. Keep it coming!
Michael Wienholt, RAC (US, EU) FDA Consulting, LLC Website: http://www.fda-consulting.com Email: email@example.com Mobile: (760) 532-6304
Kyriakides does speak about 6 minutes into the webcast you link to in your first paragraph, but her topic seems to be drug shortages, instead of the MDR or NBs. Do you have a time stamp for this part of the meeting?
That’s because the first item is pharmaceutical policy. Scroll down on the page to the medical devices item and that gets you to the medical devices part of the meeting.
Thanks, Erik. Found it!
Thanks for shearing this information.
You are very welcome!