Here is what I think about this development.
Work on a proposal ongoing
The Commission announced that ‘work on a proposal to postpone the date of application’. This tells us something but not a lot.
A decision was reached. That sounds like the work has just started, but it is not excluded that the political foundation for the process was some time in the making.
I know that I have often said on this blog and in public that the date of application would not be moved and companies should not expect it. Now it looks like it’s happening anyway. Why is it happening now when I thought it would not happen before? It’s the corona virus pandemic that provided enough pressure for things to be fluid.
As I’ve been saying all along: the only way to the change the MDR is by means of the legislative procedure, which takes a long time under normal (normal) circumstances and requires all institutional actors to agree to stick to the proposal only and not propose any amendments that prolong the procedure.
We may have the ducks sufficiently in a row for this to succeed now but this is by no means certain, which is exactly why the Commission also uses careful and cautious wording and is by no means saying that this is a done deal.
Postpone application date for one year
What will postponement of the date of application mean? Will it mean that every date in the MDR after 26 May 2020 will also move up one year? We don’t know. I think it is unlikely to happen that every date will move, which essentially means that the four years (May 2020 – May 2024) that were originally intended to ensure
IVDR? Nothing is said about the IVDR, which would certainly benefit from a year breathing space as well, as MedTech Europe remarked very rightly in my view.
What will the status of the AIMDD and the MDD be during the postponement year? We don’t know. I have heard the first suggestions that the notified bodies will not continue to accept conformity assessment requests under these directives (in so far they were still doing that). You can also not automatically count on ongoing conformity assessments or remediations to be allowed to stretch pas the date of application. It would be welcome and logical if this would happen, but we will not know before we see the text of the proposal.
What about Brexit, Swixit and Turkxit?
If the MDR would be ‘postponed’ by a year in a way that the directives continue to be in force, then the logical consequence would be that Swixit and Turkxit are postponed too, because under the directives Switzerland and Turkey are Union, and will thus remain Union until the MDR becomes applicable one year later. But this does not mean that the root causes for Swixit and Turkxit will be remedied during this year, as these are very political problems.
Brexit is different because the UK has opted to cease being Union by the end of the year no matter what, so this will not change as a result of the MDR’s date of application being moved. This would only change of the UK and the EU decide to together to prolong the transitional period with one or two years. This is politically difficult in the UK because prolonging the transitional period means that EU law applies longer in the UK and the UK has to contribute to the costs of the EU. The UK government has already stated in no uncertain terms this is not what they are planning to do. In other words, Brexit is likely not impacted by this – it still looks like an unfolding hard Brexit happening.
What don’t we know now?
Well, most importantly: we do not know what the proposal looks like. We also do not know if this will even work. That’s why we need to wait until early April to know what the proposal will really entail.
In the mean time, we also don’t know if the proposal will make it, so we have to plan for that eventuality as well.
What should you do?
This is a plan of the Commission, not an adopted amendment yet. We hope it’s a silver bullet but we do not know yet. It might even be a lead bullet.
As I have said and will keep repeating: scenarios, scenarios and more scenarios. It may be that this whole thing does not even pan out. Then what? Better have a scenario. No imagination? I’ll be glad to help you.
What should you not do?
Treat this plan of the Commission as a done deal and immediately sit on your hands. That would be a bad idea.
While the statement says that ‘this decision will relieve pressure […] to fully focus on urgent priorities related to the corona virus’, it is not saying ‘you should just drop all MDR prep work’. The MDR is still coming and you don’t know what this amendment – if it is amended – will look like in all details.
Did I say scenarios already? One of these is that the whole thing does not happen, and some others are that it happens differently than expected.