Happy new year everyone! I hope you had a good rest over the holidays because 2025 will be interesting.

I am planning to revive this blog this year and hope to put new energy in it by making it more periodical with smaller bits of information and shorter analysis. You will still get my unique perspective on things and I’ll probably not be able to help myself so will probably occasionally write more in depth stuff anyway. For the actualities and the occasional arguments with others, follow me on LinkedIn.

2025 will be interesting with short term changes to the MDR and IVDR

Everybody and their mother and then some other people even has been clamoring for changes to the structure of the MDR and the IVDR. The Commission has indicated that it will pursue measures in the short term intended to combat bureaucracy slowing down the system (such as the still not optimal functioning of structural dialogues). Member States / MDCG can be part of this solution by just implementing all points of MDCG 2022-14 and facilitate notified bodies in this regard with uniform instructions and otherwise just let the Commission do its job.

The Commission is planning to present a package of proposals more structural changes later this year (Q4), the targeted evaluation. These will be based in the fact finding exercise conducted in the second half of 2024 (of which the results are still to be published), the call for evidence currently open and may be inspired of course by the many helpful white papers, position papers, Parliament joint resolution and EPSCO paper and other initiatives. You can still submit comments and wishes in the Commission’s public consultation open until 25 March 2025.

If there is one structural change that I would personally favor it would be more accountability of notified bodies, legal review of all of their decisions by analogy to article 51 (2) MDR and more external harmonisation of their procedures, as this would force notified bodies to be more the solution to the problem than part of the problem. Let’s not forget that notified bodies wield delegated state power that enables them to unilaterally determine the rights and obligations of citizens, with at the moment basically zero accountability as this is not built into the system. What this sort of control could look like has been set out in the BVMed and VDGH white paper and Peter Liese initiative. Exercise of state authority without effective accountability, that does not sound very constitutional and I can assure that much can be improved there.

In the mean time we had the Dragi report in the EU and we have a new Commission with new plans. We will need to see how the new EU Commissioner for Health attacks the MDR and IVDR. At this point I am still wondering how this is going to happen with the degree of understaffing of the devices unit at DG Health that has a headcount of less than 10 people. It’s a big burden on a small team and I have said more than once that these people deserve great respect for what they manage to do with such a small team. If I were in charge my first action would be to properly resource this unit. Maybe someone could calculate the external costs to society of this unit being under-resourced? I bet that this these are much higher than tripling the headcount, apart from the moral hazard of not properly resourcing the Commission for devices policy.

Under-resourcing seems to be a general theme: I keep experiencing how difficult it is for EU medtech startups to secure EU based funding and having to spend a lot of the funding from whichever source on often preventable mistakes in regulatory strategy and/or pretty steep notified body fees. This is also one of the themes in the Dragi report.

Let’s not become an open air museum of bad choices in Europe!

US and EU political developments 

The FDA has been running circles around the EU regulatory system for the last years with market access procedures that worked a lot better, were way most cost effective and encouraged innovative devices to the market earlier than possible in Europe. The FDA did really well in this regard.

But will they we able to keep this up during the new administration? We will need to see how the FDA and its procedures are affected by the new administration’s plans with downsizing and gaining more direct influence over independent government institutions.

Maybe the regulatory pendulum will swing back to EU once more after all the changes planned to the MDR and IVDR for 2025 and the Union will be called one big clinical trial for the US again. Who knows!

Interruptions and discontinuations reporting as of 10 January

The new obligation under the MDR and IVDR to report interruptions and discontinuations of supply enters into force on 10 January. We now have Commission Q&A, a reporting form and still a lot of remaining questions. A lot these were asked at the webinar that I was part of together with Bassil Akra on 17 December 2024. I have emailed everyone by now that had questions that were not answered at the webinar. You might still be able to get the recording via Sean Smith of Medtech Leading Voice.

My take away is that the legal dimensions of this change are still not well understood by manufacturers and especially not be the supply chain, but also not by competent authorities. Manufacturers and distributors often have no idea how shortage reporting may impact their distribution, tender and supply agreements. For example, a shortage report may trigger an anticipatory breach or other right of the other party. Regarding competent authorities it will be interesting to see if they understand what it means in the Commission Q&A about article 10a that article 109 MDR/102 IVDR apply, meaning that the information repored to them is confidential. Yet, I have for example seen competent authorities argue that local freedom of information regulation trumps article 109 MDR / 102 IVDR and without much qualms disclose information from vigilance reports pursuant to freedom of information requests of parties working on product liability claims. Why is this kind of policy problematic? Because you cannot be sure that what you report in confidence stays confidential and will not be used against you. That makes reporting or full reporting risky and leads to a chilling effect on reporting. This will help nobody to achieve their goals. We’ll also have to see what any national enforcement policy will look like and if national competent authorities have the capacity to review the reports filed in any meaningful level of detail anyway.

If you have more questions, or need help taming the beast of article 10a, let me know.

 By the way, there will be a full article on article 10a coming (in English) in the German legal journal MPR by my colleague Judith de Wilde and me. Watch that space!

What (else) did I find interesting last month(s)?

As a new feature on this blog I decided to add a section to blogs about what I found interesting last month(s), as this may signal developments interesting to others too.

Significant changes and mergers

Mergers and significant changes keep causing headaches and costing (a lot) money unnecessarily. First, application of the concept of ‘significant change’ in article 120(3c) (b) MDR by notified bodies in the context of mergers remains  a source of controversies. While the section on administrative changes in MDCG 2020-3 Rev 1 that mentions ‘mergers’ are allowed as administrative changes, notified bodies often get hung up on the clarification in footnote 17 that the result of a merger must be that the manufacturer legal entity must remain after the merger. This has been added to clarify that asset transfers that require new certificates to be issued in the name of a new legal entity are not allowed. Notified bodies will tend to interpret this as that mergers between legal entities in which the manufacturer entity is merged into the acquiring legal entity trigger a substantial change, while this is clearly not intended by the Commission (see also Q&A on Regulation 607/2023, question 9.2).

I have found that notified bodies are typically not very good at understanding what a merger is and then cling to misinterpreting the literal text of footnote 17. This causes sometimes quite severe damage and costs for the manufacturer and/or the acquirer. It may lead to unnecessary cancelling the legacy device certificate, causing to the devices in scope of the cancelled certificate to be no longer available to the market. Yes, this is precisely what was not intended by the EU legislator with the legacy devices regime. Notified bodies do not seem to understand the existential crisis that they can put a company in by being unpredictable, slow or unreliable with respect to merger activity.

In my experience with this, contact persons at the notified bodies were without exception unqualified for a meaningful discussion that had any depth beyond the literal text of the MDR or Commission/MDCG guidance (no legal understanding or training, nor any recourse to the notified body’s legal department), which is disturbing and puts entirely needless pressure on the relationship between the manufacturer and the notified body. This reflects badly on the EU regulatory system.

My pro tip for notified bodies would be to clarify their understanding of the concept of significant change in merger scenarios with their competent authority, immensely up their game in discussion of a potential significant change in a merger scenario with a manufacturer and make sure that their legal department is available to assist front line staff that is basically never qualified for legal matters immediately to prevent unnecessary escalation.

Manufacturers and their acquirers, for their part, should never assume that the notified body will intuitively understand what a merger and its effect is (this includes basic corporate house keeping within the corporate group – never dissolve / merger a legal entity without talking to regulatory first), should explain how it is not a significant change, have this confirmed by the notified body in advance and (important) have a very good paper trail of this before implementing the merger. Be ready to escalate to the notified body’s competent authority because they may be on your side more often than you think. And MDCG, please please please why not just write this down better? It would save so much agony and costs and improve the impression of predictability and reliability of EU medical devices law. 

Batteries regulation

The Batteries Regulation keeps people very busy, as the first major phase in date (18 August 2024 for CE marking of batteries) has passed now. The Batteries Regulation is horizontal EU legislation and applies regardless of MDR or IVDR compliance, which is something many companies in the devices do not realise. Non-compliant battery leads to a non-compliant device, and there is your conundrum. We spent a lot of time in Q4 2024 helping manufacturers of medical devices and IVDs figure out how to work with the Batteries Regulation. 

Did you know that even cybersecurity is a thing for batteries? If the battery in your device has battery management software that can talk to the outside world somehow, you have a cyber security risk to manage (also as part of the device’s cyber risk management – see MDCG 2019-16, Annex II regarding battery depletion as a result of external unauthorised acces).

Would you like to go on a Battery Regulation safari with me and my battery specialist colleague Jilles like some of the biggest medtech companies have already done and found interesting? Let me know!

Swixit reversal?

It was not in the press much, but a Swixit reversal may be in the works. Not immediately, but the EU and Switzerland have taken steps again to revisit the integration of Switzerland into the EU internal market, which would mean that mutual recognition of CE marking and Swiss notified bodies might be back on the table. It’s still early days and the current package is not the same as the comprehensive Institutional Framework Agreement that turned out to be more than Switzerland could process politically, but negotiations seem to go the right way. Basically we are back to good old MRA times and a new MRA for MDR and IVDR would be very logical (and has the warm support of industry).

What could that mean for the plan of Switzerland recognise FDA approved devices? Good question! First, this plan has still not been implemented. Secondly, given these developments it might never be.

Watch the negotiations between the EU and Switzerland as the MRA and its MRA annex are filled in in the coming months.

eIFU regulation amendments coming – eIFU for all professional use devices

After the consultation last year about extending the eIFU regulation to other professional use devices the Commission has now announced that it plans to adopt the new implementing regulation in Q2 2025, which will allow to issue electronic instructions for use for all medical devices intended for exclusive use by healthcare professionals. We are still very much in the stone age in Europe on eIFU, since the underlying assumptions to the current eIFU regulation are that basically nobody has reliable access to internet and that everyone saves their paper IFUs for reference use. By now all these underlying assumptions have proven wrong and outdated, and it’s time for a thorough update.

Although this still does not seem to be in the stars for the upcoming update, many other jurisdictions allow eIFUs for lay users as well, and there is no reason for the EU not to do so either given the experiences in other jurisdictions. While the outcome of the last consultation has not been published yet, I’ve seen the results and even professional users overwhelmingly agree that this would be a good idea for lay users. In fact, let’s not forget how only providing paper IFUs disadvantage people with disabilities and are even contrary to other EU law intended to make life easier for persons with disabilities by obliging IFUs for products to be provided in multiple sensory channels. Who use a lot of medical devices you ask? Indeed: persons with disabilities, generally. Let stop limiting their autonomy with these unjustifiably outdated eIFU rules.

Reclassification of WET

One of the problems with well-established technologies is that you would think they could do with some less strict oversight (especially on the class III and IIb classes). The Commission aims to reclassify certain well-established technologies, for which the application of the general classification rules in Annex VIII of the MDR is not proportionate to the devices’ nature and respective (limited) risks, with a new implementing act planned for Q4 2025.

New consolidated version of MDR published

Many people don’t understand how Eur-Lex works and get their MDR and IVDR text versions wrong. The most recent consolidated version which includes all the last changes have just been published for the MDR but not yet for the IVDR (which is still in the consolidated version of July 2024). Understanding how Eur-Lex works and how to use this incredibly versatile tool is a very good investment of your time (next to reading the Blue Guide). If you ever need to recruit or vet regulatory staff or consultants with EU capabilities, ask them two these things: show me how Eur-Lex works and have you read the most recent version of the Blue Guide? In case of unsatisfactory answers, these are not the people you’re looking for.

Conference appearances planned

A new year, new conferences. What am I up to? Currently I’m planning to be at

• The OSMA Winter 2025 meeting in Orlando 21-23 January – if you’re into orthopaedics (and SeaWorld), come and meet me there!
• EUCROF Copenhagen 2-4 February, because clinical investigation and performance evaluation is and remains a tricky subject. Pharma companies for example routinely forget that assays used in clinical trials are likely to IVDR controls too. Why would that be relevant? Well, how about all of your clinical trial data collected with the use of these assays not being valid – that should get your management’s attention.
• Lab Quality Days in Helsinki 6-7 February speaking about AI development in-house by health inastitutions and about the regulatory lasagna created by the AI Act. If you are doing anything with AI in lab setting, this will be your go-to event.
• The C5 Life Sciences AI Summit – Europe on 25-26 March in Brussels. I am co-chairing this event and if your company does anything with AI in life sciences, this will be an interesting event for you.
• The RAPS EU Convergence in Brussels 13-16 May – I will be presenting about MDR/IVDR and their relation to environmental / Green Deal regulation in the EU (like the Batteries Regulation for example) – many attendees found this very interesting in at the EU RAPS Convergence in 2024.
• MedTech Summit in Berlin 16-20 June, where I will be presenting a regulatory forecast “Locking Down the Law: BVMED-VDGH, MTE White Papers, Peter Liese Proposal, Targeted Evaluation – Where is This All Going?”

So if you’re interested in meeting me, meet me at these international events! Others are in the works and I’m planning a boatload of webinars for this year as there is so much to talk about.

And: this year will likely see the third edition of The Enriched MDR and IVDR, to which I’ve added presently 200+ additional pages of substantive content and of which I’ve revised and updated a lot of content too (that was a lot of work that did not go into this blog).