Brussels has finally blinked. On 8 September 2025, the European Commission launched a call for evidence to simplify the MDR and IVDR. The window is short — it closes on 6 October 2025, but the signal is clear: the Commission is ready to revisit rules that have become heavier than the risk they were meant to control.
What’s on the table?
The Commission wants to use this feedback to:
- Slash administrative burden — fewer reporting obligations and streamlined governance rules.
- Bring predictability to notified‑body certification, with faster, clearer routes.
- Establish proportionate conformity assessment for low and medium‑risk devices and devices catering to special patient needs.
- Strengthen international cooperation across the EU medtech ecosystem.
- Align the device rules with other EU legislation to avoid cross‑regulatory friction.
- Accelerate digitalisation across the sector.
Why now?
This move sits alongside the Commission’s ongoing targeted evaluation of MDR and IVDR (underway since 2024). Stakeholders from Parliament to Member States and industry have been vocal: timelines to achieve CE marking are unpredictable, requirements feel disproportionate to risk, and SMEs are disproportionately burdened. The concern is not academic: costs, competitiveness and ultimately patient access are all negatively affected.
How could the changes land?
We can expect reform through amendments to MDR and IVDR via the ordinary legislative process, informed by this evidence call. Simplification is the aim and the intent is not piecemeal fixes. It is coherence and consistency across the single market, with less room for national fragmentation that forces manufacturers into a patchwork of rules.
The UK angle: doors opening?
From the UK side, the stars may be aligning. In July 2025, the MHRA signaled openness to indefinite recognition of CE marks under MDR and IVDR by proposing a consultation later this year. If Brussels genuinely trims back burden and sharpens timelines, the case for UK‑EU alignment would strengthen further. Northern Ireland already follows the MDR and IVDR under the Windsor Framework; a more business‑friendly EU regime could make broader UK reliance on CE marking and other aspects of the MDR and IVDR less contentious and more attractive for the medical device industry.
What to do now? (Deadline: 6 October 2025)
- Respond to the Commission’s call for evidence: you can tell Brussels where the friction is and what would unlock capacity (documentation, sampling, SME pathways, legacy device transitions, clinical evidence expectations, post‑market surveillance, digital submissions).
- Frame asks in outcomes: faster CE marking decisions, clearer notified‑body capacity planning, proportionate routes for lower‑risk categories.
- Track the MHRA consultation: UK-based manufacturers should keep submissions aligned on both tracks to maximise convergence.
We would like to thank trainee solicitor Raghav Kaushal for their valuable contribution to this article.
