^{Published on 14.4.2026}

The European Commission's proposed updates to the MDR and IVDR represent the most significant recalibration of the EU medical device framework since the regulations came into force. The goal is to address some of the most persistent issues that have emerged. For decisionmakers at device companies, the question isn't whether these changes will affect your business, but whether you'll be positioned to take advantage of them.

What's driving the change and what is the timeline

The Commission's December 2025 proposal responds to problems that have been compounding since the MDR and IVDR entered into force: compliance costs that have squeezed smaller portfolios out of the market, certification bottlenecks caused by notified body capacity constraints, and inconsistent enforcement across Member States that has made EU market planning unpredictable.

The proposal is now moving through the EU legislative process. The current target for entry into force is around Q3 2027, though that timeline could shift if Member States challenge elements of the revision during negotiations. That gives companies a window to think strategically about what's coming.

Lower barriers for certain devices, faster routes for innovation

The proposal recalibrates classification rules for several device categories, including software, reusable surgical instruments, and well-established technology devices. For companies carrying legacy products through expensive conformity assessment cycles, this could materially reduce compliance costs and free up resources for higher-value work.

For companies with innovative or breakthrough devices, new dedicated regulatory pathways — including rolling reviews and conditional certificates — could significantly shorten time to market in the EU, a route that has historically been slow compared to other major markets.

Restructured notified body relationships

The proposal introduces meaningful changes to how manufacturers interact with notified bodies. Risk-based auditing, mandatory fee reductions for SMEs, and formal dispute resolution mechanisms shift the dynamic from one where manufacturers have had little recourse to one with clearer rules of engagement. The removal of fixed five-year certificate cycles in favor of continuous, risk-proportionate surveillance also changes how companies need to plan and resource ongoing compliance.

More flexibility in clinical and performance evidence

Both MDR and IVDR would allow more proportionate approaches to clinical and performance evidence, including expanded use of equivalence claims and formal recognition of non-clinical data where appropriate. For portfolio planning, this matters: evidence strategies that were previously closed off may become viable, and the cost calculus on certain development programs could shift.

What this means for your strategy

The direction of travel is clear: a framework that aims to be more proportionate, more predictable, and more aligned with how modern medical technology actually works. If your portfolio, pipeline, or market access strategy in the EU is likely to be affected by these changes, now is the right time to assess the implications and follow the approval process closely. The picture will become clearer the further we go.

If you would like expert support in understadning regulatory nuances in your upcoming or ongoing project, describe it in our contact form and we will get back to you shortly.