2 April 1st reading vote: what's next for the MDR and IVDR?

Schermafbeelding 2014-04-05 om 19.47.45

We had the first reading vote by the European Parliament on 2 April. Let’s put it in perspective.

The previous last important iterations in the legislative process are the EP’s plenary vote on 22 October 2013 and the Council’s discussion of the MDR proposal with respect to reprocessing and market access mechanism.


The Parliament’s plenary vote has in the mean time been voted on in a formal first reading by the Parliament on 2 April 2014  as to fix the proposal. The reason for the Parliament to do this now is essentially to fix rapporteur Roth-Behrendt’s fact-free legacy to make it more difficult for a new Parliament to easily change it after the elections (“The European Parliament voted on its first reading of the draft legislation, in order to consolidate the work done so far and hand it over to the next Parliament. This ensures that the MEPs newly elected in May can build on work done during the current term.”, says its press release) and to  force the Commission and the Council to move forward on the dossier, which it hoped they would have started to do way before.


This means that the Commission is now also on the spot. The next procedural step will be the formal response of the Commission in 4-5 weeks. and has to decide whether to go along with the Parliament’s text or to come up with its own amendments. So far the Commission has been keeping its cards very close to its chest as to not upset the political actors it has to deal with in the procedure.

Happy Parliament?

Do we have a happy Parliament now? They did confirm the 22 October 2013 position with overwhelming votes, but also with a telling 63 abstentions. Of course the ENVI committee claimed victory in a press release stating that there would be “better controls”. Much more interesting was the press conference that rapporteur Roth-Behrendt held afterwards, in which she basically blamed everybody but herself for the way this dossier is spinning out of control politically, conveniently ignoring the political handgranade she exploded with the ENVI committee position and unfounded crass accusations on the part of stakeholders, which basically destroyed the possibilities for normal dialogue with stakeholders. You can watch the video for entertainment purposes and amaze yourself about how many unfounded fact-free statements a departing politician can spout in a short while. Or you can save yourself the aggravation and satisfy yourself with the twitter summary in tweets of the ever observant Robert van Boxtel / @robertmdproject pasted in this blog on the left. When rapporteur Roth-Beherendt is gone, hopefully cooler and more evidence based minds will prevail in the Parliament and we might actually even get somewhere with this dossier.

Happy member states? Where do we go from here?

Get somewhere…. that would be nice. But we also need the Council. And the Council is hopelessly divided tat the moment. Persons involved in the Council negotiations have informed me that also on many other important points the member states are as divided as transpired in the last Council meeting that publicly discussed the proposals. There are shifting coalitions in different subjects. Even after the 1st reading in Parliament the Council is not under a deadline at this stage in the procedure, and as yet has not started to negotiate with the EP with a view to reaching a compromise text. The current expectation is that the member states will not reach a compromise with the EP before the European elections in May 2014 and probably not before the end of 2014. Even though the Greek presidency promised to get somewhere with this, it is unlikely that they will. The trialogue between en Commission, Parliament and Council will therefore likely not begin before early 2015. The elections may well reshuffle the political landscape, which leaves a lot of insecurities about the legislative projects of MDR and IVDR post-elections, regardless of the Parliament’s first reading.

Navigate through our knowledgebase

Related articles


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


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


MDR and IVDR amendment has entered into force now

Today is the day that the amendment, aka the ‘extension’, to the MDR enters into force because it was published in the EU’s Official Journal today, number L080. As you are reading this,…

Read more