Insights

The European Commission has proposed a targeted revision of the EU Medical Devices Regulations, aiming to simplify rules, reduce administrative burden and support faster access to safe and innovative medical devices across Europe.

The proposal addresses structural challenges identified in the implementation of the MDR and IVDR, including complex procedures, divergent application of requirements and certification processes that may affect predictability, competitiveness and device availability.

Key actions include:

• More proportionate conformity assessment requirements.
• Improved coordination among regulatory actors.
• Enhanced digitalisation of regulatory processes.
• Broader use of real-world evidence.
• Stronger EU-level scientific and regulatory support through expert panels and the European Medicines Agency.
• Dedicated support for SMEs, breakthrough technologies, orphan devices and AI-enabled medical devices.
• Continued focus on maintaining high standards for patient safety and public health.

For manufacturers and other economic operators, the proposed changes may have a significant impact on regulatory planning, technical documentation, conformity assessment strategies, post-market obligations and market access activities.

This initiative represents an important step toward a more efficient, predictable and innovation-friendly EU regulatory framework for medical devices and in vitro diagnostics.

RPN will provide any further update and is available to provide full support for Medical Devices regulatory activities across the whole product lifecycle.