The European Commission has announced significant changes that may soon reshape MedTech regulation in Europe. The first step on this path is to gather proposals and views from manufacturers, clinicians, notified bodies, and patient organizations.
The aim of the consultation is to revisit the rules governing medical devices (MDR) and in vitro diagnostics (IVDR), which came into force in recent years and triggered a host of challenges: device shortages, excessive procedural complexity, rising costs, and risks to Europe’s competitiveness.
What’s on the table looks more like targeted fine-tuning than a wholesale overhaul: reducing administrative burdens, making conformity assessment more proportionate for low- and medium-risk devices, speeding up certification timelines, and achieving greater alignment with international standards. In the Commission’s view, these steps should ease market entry for innovation, support small and medium-sized enterprises, and at the same time maintain a high level of patient safety.
By way of reminder, on 12 December 2024 the European Commission launched a Call for Evidence and a Public Consultation on the MDR/IVDR — the first phase of work toward future changes. The second phase has now begun: a Targeted revision with a deadline of 6 October 2025. The consultation is open to manufacturers, clinicians, notified bodies, and patient organizations. Submissions can be made through 6 October 2025 inclusive. Proposals may be submitted via the European Commission’s “Have Your Say” portal.
As of the time of writing, more than 60 comments and proposals had already been received.
There are, however, several angles to consider. We recently discussed the hidden pitfalls of shaping Europe’s modern MedTech market with Mike Pogose, Director of Quality Assurance and Regulatory Affairs at Hardian Health, in this article. Mike, for example, noted: “Many ambient scribe manufacturers promote the benefits of their software lessening the administrative burden on clinicians, often citing two features, clinical coding and time saving. At the same time, I believe that manufacturers are avoiding regulation. Not evading, but avoiding regulation because of grey areas in legislation and in official guidance.” This underscores the need for a two-way dialogue: not only from manufacturers and service providers, but also from users and the organizations that protect their rights.
It’s a complex and engaging topic. That’s why on 16 October we’ll host the webinar “Health & Wellness Apps: Where EU Regulations Are Going,” where, together with Sigrid Berge, we’ll delve into the details. You can register here.