I have done more traveling than I probably should have in January and February between the US, the Middle East and various places in Europe.

One of the constant themes was the place of a regulatory regime in the world and how to calibrate the regulatory system just right in the way that it meets both the requirements of society and industry the best. I attended very interesting discussions on this subject in Dubai at the Mecomed RAPS MEA event on 30 January. 

At the Lab Quality Days in Helsinki (a conference which I highly recommend if you’ve not attended so far) the red thread was how to calibrate the IVDR and EU horizontal legation like the AI Act in a way that you create a predictable and reliable regulatory system, in which we did not succeed that well in Europe. This lead more and more companies to abandon the historic ‘Europe first’ strategy.

The last IMDRF meetings were flush with talk about international reliance, leading to more and more regulatory convergence. It breaks my regulatory heart to see that international developments seem go the other way now.

International reliance assumes a two way street and a willingness to be a good example by setting standards others want to follow and following them yourself as well.

In that regard we have overshot the mark in Europe with our over-engineered medical devices regulations with its overly complex transitional regime and our complex layers  regulatory lasagna piled on top. At the same time the system is decentralised and under-resourced both on EU and national levels. Reality is showing that this has led to a rather over engineered regulatory system that has difficulties delivering on its promise. 

I have expressed doubts in my last blog about the course taken by the current US administration, the outlines of which seems to become clearer and clearer as the US seems to have opted for a very rigorous stripping down of its institutions, especially where they are active internationally (or manage nuclear weapons), and for a zero sum perspective on international relations, including alianating allies wherever possible.

The question now is how the US will fare in international reliance with this approach and how many countries will (continue to) see the US as a reliable source of rule based thinking and two-way relations.

If we look at the WHO regulatory reliance definition (“The act whereby the regulatory authority in one jurisdiction takes into account and gives significant weight to assessments performed by another regulatory authority or trusted institution, or to any other authoritative information in reaching it own decision.”) you can immediately see how this will be problematic for the US. These days nobody is bigger than the rest of the world no matter how hard you try.

How this will translate to devices policy both national and international is still not completely clear but I am not optimistic based on developments so far. For example, what will all of this mean for the US participation in the IMDRF? In this regard it’s encouraging that the Commission has announced that it will step up its international activity, which hopefully will include a more active participation in the IMDRF.

This means that Europe is in a great position to restore its position as a jurisdiction of choice for regulatory approval and regulatory reliance, IF it can get its act together. If.

EU competitiveness compass, targeted evaluation and implementing acts

How will the EU get its act together? As I’ve blogged earlier this year by means of a strategy of quick anti-bureacracy wins and targeted changes to the MDR and the IVDR.

I have already seen the Commission announce the first changes to the MDR and IVDR by means of regulatory and non-regulatory actions (the quick wins):

• Implementing regulation expanding the scope for e-IFUs regulations
• Establishment of an expert panel on orphan and paediatric devices
• Expansion of the list of well-established technologies (WET)
• Reclassification of certain well-established technologies 
• Implementing rules regarding requirements to be met by Notified Bodies

The Commission is still on track to present a proposal for legislative changes later this year. The member states also have the option to finally deliver on their ideas set out in the MDCG 2022-14 position paper.

In a larger context at EU economy level the Commission has presented its Competitiveness Compass for Europe, which, if it will really be rolled out as promised in this communication (COM 2025 (30) final), should lead to significant simplification and deregulation of EU law and a reduction of ‘regulatory ratchet’ – the politically correct term for regulatory lasagna. Even medical devices are explicitly mentioned in the Compass, in relation to simplification of regulatory requirements.

The Compass is functionally built around three pillars and five horizontal cross-cutting measures. Other than from a regulatory perspective the medical device industry may find it interesting that the EU wants to make it much easier for startups to scale making access to cross-border investments much easier, among which by means of the “28th regime”. This is a  a single, harmonised set of EU-wide rules that innovative companies can benefit from wherever they invest and operate in the Single Market. A Data Union Strategy should improve and facilitate secure private and public data sharing, simplify the regulatory regime and its application, and accelerate the development of new systems or applications.

While this all sounds totally super on paper, I still remember earlier initiatives in 2008 that were supposed to make the EU the most competitive economy in the world and at the moment we’re not there yet. 

Like the US at the moment, the EU is its own worst enemy in the execution of policy and regulation. The EU is divided among its member states and encroached upon by populists that do not believe in the European project but would rather take their country back to the early fifties when everything was better, people still said hello to each other in the street, life was simple, and the sun was shining every day. 

The biggest challenge for the EU will be to rally the member states behind this compass and to do much better in convincing the population what the benefits of the EU are. 

It’s frankly ridiculous for example how the EU negotiates international trade agreements that are subsequently torpedoed  wholly or in part on national level because of local interests of groups of people that choose not to see the bigger picture based on EU hostile desinformation. This does nothing for the reliability of the EU in the world.

What did I find interesting last weeks?

• The competitiveness compass of course. Go Europe!!
• There was an updated notified body Q&A document (MDCG 2019-6 Rev. 5) from the MDCG with rather interesting guidance on structural dialogues (section I.6) and a possible (and non-exahustive) list of structured dialogue topics. This means that every notified body should be willing to open a dialoogue on these matters without deflecting it out of hand with a ‘this is consultancy’ statement. It will force notified bodies to think about more about how not to be the department of ‘no’ but rather of ‘it’s better to approach it this way’. Manufacturers, for their part, should take care not to ask open ended questions and expect the notified body to tell them exactly how to comply with the requirement, because that would be consultancy. It will also assist notified bodies in being more service minded for the overall benefit of society, also a nice benefit.
• The Commission presented an overview of five implementing acts at the Mecomed RAPS MEA conference on 30 January that it is working on with a view to fix aspects of the MDR and IVDR quickly, among others an implementing act on eIFU (expected, but scope still unclear) and (this was what I found especially interesting) an implementing act on harmonization of notified body procedure. This would fit very well in the industry advocated ‘harmonization through centralization’ concept – so watch that space as the implementing acts become available for consultation. Also, interestingly, the Commission will increase international cooperation.
• We are waiting for the opinion of the Advocate General in a very interesting borderline case at the EU Court, which is about one of my borderline hobby horses: weak reversible bonds between substances and bacteria, such as Van der Waals forces. Their unfortunate mentioning in MDCG 2022-5 has led to a situation where too easily products that work based on Van der Waals forces are deemed to have a pharmacological mode of action without any discussion of actual science, which (unfortunately) is a no-so-scientific policy overreach. Why? Because if all Van der Waals bonds would be a pharmacological mode of action this would make most of the most of the weak bonds that keep the fabric of the physical world together pharmacological – and that’s a huge oxymoron. The ubiquitous nature of Van der Waals forces disqualifies them as pharmacological interactions. Van der Waals forces occur between all molecules that come into close proximity – they’re present between water molecules in a glass, between proteins in your body, between air molecules, and even between your fingers and the surface you touch (that’s hopw geckos stick to walls). They arise simply from temporary fluctuations in electron distribution that create momentary dipoles. If we were to classify Van der Waals forces as pharmacological interactions, we would need to consider:
  – Every protein-protein interaction in your body as pharmacological;
  – Every time water molecules interact with cellular components as pharmacological;
  – Every instance of membrane lipids associating with each other as pharmacological; and
  – Even the adhesion of dust particles to surfaces as pharmacological.
  This would make the term “pharmacological interaction” lose its meaningful distinction from basic physics. The essence of pharmacology is the study of specific, targeted interactions that produce defined biological effects. A pharmacological interaction needs to be selective and purposeful – like a key fitting into a lock – rather than a universal background force that affects all matter.
  This is why we should rather reserve the term “pharmacological interaction” for specific binding events that trigger defined biological responses, while recognizing Van der Waals forces as one of several physical forces that contribute to, but don’t themselves constitute, these interactions. I am not alone in my criticism regarding MDCG 2022-5. Member States Italy and Germany have also concluded that the concept of pharmacological mode of action set out in it is not sufficiently precise to be helpful as guidance. Hopefully the EU court will be smart about this.The AG is not yet the final judgment of the court but the EU Court follows its AG in the majority of the cases. I am watching that space!
• Withdrawal of the AI Product Liability Directive – the Commission withdrew the proposal for the AI Product Liability Directive because there was no foreseeable agreement in the legislative procedure. One of the main bones of contention was the eroded burden of proof of the claimant in case of AI products that formed the core of the directive. This will have implications for medical devices that implement AI or are an AI system themselves as these will remain subject to general the general product liability directive, see the Commission’s work programme and annexes.

Where to meet me?

• RMD 2025 in Brussels on 24-25 February on changes to the MDR and IVDR – always very interesting and high quality with great access to leading experts
• Irish MedTech article 10a workshop on 5 March in Limerick
• RAPS Netherlands Chapter in Leuven on in-house produced devices on 5 March. The RAPS NL Chapter is very active and has a very high quality of information exchange and networking. If you work in devices RA/QA and speak Dutch, RAPS NL will be indispensible.
• C5 Life Sciences AI Summit in Brussels, which I’m co-chairing, on 25-26 March
• Lustrumsymposium ‘Transitie naar een Groene OK: het onmogelijke mogelijk maken!’ – about greening up single use devices, requirements for reprocessing of single use medical devices and other measures to make the operating room greener, 15 April
• RAPS Euroconvergence in Brussels on 12-15 May