Can the changes to MDR and IVDR reduce the burden on SMEs?

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TOP 56 in the Federal Council (08.05.2026): Targeted adjustments to MDR and IVDR

With this proposed regulation, the European Commission addresses key challenges in implementing Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR). A particular focus is on relieving the burden on small and medium-sized enterprises (SMEs).

Starting position

The MDR and IVDR have strengthened key elements of the regulatory framework, particularly with regard to clinical evidence, conformity assessment and market surveillance.

At the same time, practical implementation has shown that the requirements are in many cases associated with high complexity, limited planning and considerable costs. This affects SMEs in particular and has an impact on innovative capacity and product availability.

Key features of the proposal

The proposed adjustments are based on identified structural bottlenecks:

• Simplifying requirements for low and medium risk class products
• Facilitation for products to treat rare diseases
• Introduction of binding deadlines for conformity assessment procedures
• Waiver of recurring recertifications for established technologies under certain conditions
• Stronger involvement of the European Medicines Agency (EMA) for early scientific advice
• Reduced fees and targeted support offers for SMEs
• Clarifications with regard to AI-based medical devices

Classification and evaluation

The proposed measures address significant stress factors, in particular with regard to the duration of proceedings, predictability and access to regulatory expertise.

At the same time, key structural challenges remain:

• The basic complexity of the regulatory system is not significantly reduced
• Clinical evidence requirements remain largely unchanged
• Capacity bottlenecks at notified bodies may continue to have a limiting effect
• The effectiveness of the measures depends largely on consistent implementation in the Member States

Against this background, the proposal should be seen as a step towards making the legal framework more proportionate. Whether this results in a substantial relief for SMEs will depend largely on the practical implementation and the actual shortening and predictability of procedures.

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