The German angle

After having contributed to the improvement of medical devices legislation in many ways over the years (most recently by helping the European Parliament to come up with an initiative for targeted amendments to the MDR) it is now my great honour to have been invited as external independent expert to assist the Bundestag (the German Parliament) in forming the MDR revision agenda that the German government should take to Brussels.

Why should we watch what happens in German Parliament?

The Council is one of the three important institutional actors in the legislative procedure for amendments to the MDR, the co-decision procedure. And Germany is one of the most active and heavyweight Member States in the Council when it comes to medical technology matters so what Germany wants with the MDR will carry a lot of weight.

We also know now what the European Parliament wants (Peter Liese’s initiative), and we also know that the Commission is keeping its cards close to its chest for the moment although we do know that also the Commission wants amendments to the MDR in the short term (the planned ‘targeted evaluation’) and may well be working on those already.

The Bundestag session will take place tomorrow from 14:45 to 15:45 CET. You might be interested in the position papers (Stellungnahmen) filed for this session (including mine), which can all be conveniently downloaded here. For those interested, the session in the Bundestag has a public live stream that you can watch (in German).

What you will see happening tomorrow may be another important step in how the MDR and IVDR may change soon.

Convergence happening

As I’ve recently posted on this blog, there is a momentum of converging of positions building up. For example, the Peter Liese initiative was generally received quite well by industry as I’ve been told by several people. But we cannot fix the MDR alone as the IVDR suffers from the same issues, as I have argued in my position paper sent in for Parliament session tomorrow.

This momentum will culminate in the short term and will lead to targeted but significant revisions of the MDR and IVDR to fix the bigger inefficiencies and improve these regulations by building on the solid foundations that are already there with the experience gained since 26 May 2017. My guess is that we will see this happen early 2025.

For me personally the most important points as a legal and regulatory expert are that

  • the governance system for the MDR and IVDR needs revision to become more centralised and less bogged down by individual member state / notified body hobby horses and hangups; and
  • principles of good administrative practice need to be implemented in the system to ensure that the delegated state powers of granting market access through conformity assessment are exercised responsibly and are subject to standard legal review as befitting in a democratic society.

Everyone is part of the solution

Everyone needs to be part of the solution to make the system work because as things go the MDR and IVDR are underdelivering in a completely preventable way as they are suffering from problems caused by policy choices, both on EU and national level (notably those underlying the transitional regime and Member States’ resourcing of the implementation and notified bodies re-notification). The good part about this type of choices is that they can be remedied. Because let’s face it: we are all (potential) patients and have dear ones that are (potential) patients, and we would like a devices regulatory system that lives up to its promise. And then there is the geopolitical dimension: why would the EU, who prides itself on being world champion in setting the bar for regulation, inflict this crisis of healthcare and innovation upon itself if it is entirely preventable?
It’s time for everyone to step up and do better. Because who has two thumbs and can be part of the solution? Yes that’s right – that is you. You could start right now.

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