But weren’t they supposed to vote on it on the 14th?

Short update on the MDR amendment proposal because quite a lot of people were expecting the European Parliament to take a final vote on the MDR amendment proposal today. A lot of them that watched the vote on the Parliament’s streaming services were surprised and disappointed that the vote seemed unclear: no vote on the text of the proposal? What was that?

To clarify what happened: today the Parliament voted on the request to treat the MDR proposal in the accelerated procedure, which was literally what it said in the Parliament’s agenda, so no surprise there if you know how this works. By the way, it’s an IVDR proposal too and not just an MDR party, as the IVDR sell-off period is proposed to be removed.

While it had been pre-discussed with the Commission that this would be put on the agenda and preferably adopted rapidly without issues, drama or amendments in the accelerated legislative procedure, rule 163 of the Parliament’s procedures still requires a vote on this. And that happened today.

The vote was unanimous and now the vote on the substance of the proposal is scheduled for Thursday 16 February. Amendments can (theoretically) still be proposed by the Parliament on Wednesday, but also on this point solid pre-discussion between the Commission and the ENVI committee will likely lead to a no amendment situation.

If you want to check out the proposal for inconsistencies between languages or in your own language (or in another of the many interesting ones we have in the EU), see here as it has been translated in all language versions (a requirement for adoption).

So please bear with the Parliament for just another two days until the vote on the proposal, and then some more days as the proposal will trickle through the publication process to the Official Journal.

And, as the name of the journal suggests, it’s not official until published in the Official Journal – and since the proposal indicates that the normal 20 days delay period after publication is foregone for this proposal – it will enter into force on the date of publication in the Official Journal and not before. There is no official timeline for that. For the last accelerated amendment to the MDR it took about a week between vote in the Parliament and publication in the Official Journal – Parliament vote was on 17 April 2020, and the amendment was published in the OJ on 24 April 2020 (one week later). So let’s hope they can be just as quick this time. I know that it will make a difference for certificates expiring already, so no time to waste!

In the mean time, the proposal leaves many questions unanswered, so if you have any: don’t hesitate to contact me because answering those questions is what I do best. And boy, did I answer a few about this proposal already. I can safely say that now (actually some time before already) is a good time to make some scenarios about how the proposed amendment will affect your devices business if you haven’t yet done so. Scenario anyone?


Navigate through our knowledgebase

Related articles

Article

Happy 26 May 2024!

The MDR and IVDR are now in force for seven (7) years, and they are not in good shape. I think it is safe to say that they did not deliver on…

Read more

Article

A case of so-called fiscal neutrality

Sometimes you come across cases that violate Mandalorian Creed: “One does not speak unless one knows.”. This happened to me last week when I read the Dutch Supreme Court’s judgment in a…

Read more

Article

Can we fix / improve the MDR and the IVDR?

Or in other words that I’ve asked on this blog before: can the maker repair what he makes? This blog will argue that he can and he should. It still happens to…

Read more