MDR 2.0: news from the "High-level conference"

 On 16 March, the High-level conference on medical devices was held in Brussels, organized by the European Commission and focused on “innovation and patient safety,” with particular attention to the proposed revision of the Medical Devices Regulation (“MDR 2.0”), presented on 16 December 2025. European Commissioner Olivier Várhelyi acknowledged that the current MDR, adopted in 2017 in response to serious incidents, has failed to strike an appropriate balance between regulatory stringency and system functionality. The revision aims to streamline the regulatory framework while keeping patient safety as the central objective.
 A separate proposal to amend Annex VII on Notified Bodies was also discussed, introducing strict timelines for conformity assessments—an approach strongly opposed by the Notified Bodies themselves.
 Rainer Becker (DG SANTE) illustrated the more “tailored” approach of MDR 2.0, including reduced PSUR update requirements, potential reclassification of certain accessories, and a loosening of surveillance activities, such as the removal of unannounced audits and the five-year validity limit for certificates.
 However, significant concerns remain regarding the impact of these measures on patient safety, and no clear timeline was provided for the adoption of the new regulation. The overall mood at the conference was one of cautious optimism mixed with skepticism. 

Transcript

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Welcome to Compliance Espresso, the podcast where we break down European medical device legislation with clarity, rigor, and just a hint of irony. Short episodes designed to give you reliable guidance in just a few minutes, like a good cup of coffee. I'm Nicola Focci. I've been working in the medical device field for over 25 years, including 8 years inside notified bodies. Let's get started! On March 16th, a high-level conference on medical devices was held in Bruxelles, hosted by the European Commission and announced a month and a half earlier. Innovation and Patient Safety was the event's subtitle, which aimed to shed a light on what I like to call MDR 2.0, the proposed amendment to the regulation presented on December 16, 2025. Olivier Varhely, European Commissioner for Earth and Animal Welfare, took the floor. The current legislation, Varheli said, was adopted in 2017 in response to the serious incidents we all know about. But lawmakers choose a stringent regulatory approach which, as we have seen, failed to ensure a proper balance. Nine years on, we must face reality. A reality that, I would add, only partially benefited from the publication of Regulation 607, a real mess in my opinion. Europe, Varheli continued, considers the medical device sector crucial, not only economically, but above all from the patient's perspective. The purpose of revising the regulation is therefore to rationalize the regulatory framework and make it robust for the future, always keeping patient safety in view. We have listened to your requests, the commissioner concluded, addressing an audience made up of almost every type of stakeholder, from manufacturers to notified bodies, from researchers to patients. Olivier Varley also spoke about the proposed amendment to Annex 7 of the regulation, which contains the requirements that notified bodies must meet, presented on December 12th. Why there should be this chaos of two parallel proposals instead of one is a mystery to me, but let's move on. It will in any case be an implementing regulation similar to 607, imposing fixed time frames in days for conformity assessment activities. Review of trading a file within 90 days, quality system audit within 120 days, and so on. It will be adopted very soon, even this month, Varely promises, much to the delight of notified bodies who, through Team MB, the European Trade Association, strongly opposed such deadlines, considering them unrealistic. But let's get back to MDR 2.0. The second speaker, Rainer Becker of DigiSante, continued with some concrete examples, and it is positive to see a speaker bring actual devices on stage, a needle, an implantable device, a small screwdriver, all to explain that with MDR 2.0 we move from a one-size-fits-all approach to a tiloid structure by device type and therefore a simplifying approach. Becker mentioned the PSUR, the Periodic Safety Update Report. Today, manufacturers of class 3 and 2B devices must update it at least annually and every two years for class 2A. MDR 2.0 provides for class 3 and 2B a Sure review in the first year and then every two years. For class 2A, it reports when necessary. And then, this small pacemake SKU driver, Becker said, which is currently considered class 3 as an accessory to an actively implantable device, could be classified as class 1. All very good news for manufacturers, but perhaps a little less so for notified bodies. Or that intends to remove the maximum validity term of certificates currently set at 5 years. Or that it wants to eliminate unananswered audits every 5 years, an institution that under MDD was even required every 3 years. Are we really sure that all this preserves patient safety? Of course. Why should I visit every year a manufacturer who produces a device that has been sold for ages, like a simple needle, with no changes or incidents? But well, perhaps because I want to be sure they continue to do it well. The fact is that at this high-level conference, no one, and I mean no one, was able to say when the blessed MDR 2.0 will be adopted, even approximately. So, will it be the second half of 2026? The first half of 2027? No one knows. And we do not know, of course, whether the final text will remain the same as the proposal of December 16th. At the end of the conference, participants' opinion scrolled on the screen an equal mix of optimism and pessimism. One person wrote: Since the MDR didn't work, we thought we could make new mistakes. Let's hope not. You've just listened to an episode of Compliance Espresso. The next episode will be out in two weeks. If you have comments or suggestions, feel free to write me at nicola at focci.it. Thank you for listening.