After almost eight years of implementation, the EU medical technology regulations, the In Vitro Diagnostic Medical Devices Regulation 2017/746/EU (IVDR) and Medical Devices Regulation 2017/745/EU (MDR), have not yet lived up to their objectives of establishing a “robust, transparent, predictable and sustainable regulatory framework for [in vitro diagnostic] medical devices which ensures a high level of safety and health whilst supporting innovation” (paraphrased from preambles 1 and 2 of the regulations). In addition, each regulation has been given two extensions to give more time for the products on the market to transition to their rules.
While considerable work has been done by all stakeholders to address implementation challenges, there are structural issues in the regulatory system which make it slow, unpredictable, costly and complex, and lacking in agile pathways for innovation. These structural issues cannot be solved through the implementation of IVDR and MDR alone. The system needs significant improvements through both immediate and structural changes.
In recognition of the challenges with the regulatory system, European Union institutions have called for change:
- The European Parliament has called in their October 2024 resolution for urgent revisions to the MDR and IVDR.
- In their EPSCO Council meetings, Ministers of Health have called for IVDR/MDR reforms, including cutting down on ‘red tape’, supporting innovation and reforming the governance system.
- The European Commission is running a Targeted Evaluation of the IVDR and MDR until end-2025.
- The European Commission also plans to publish several implementing acts in 2025 to address urgent topics.
In 2023, MedTech Europe has published its vision for The Future of Europe’s medical technology regulations which outlines the pillars for robust, transparent, predictable and sustainable regulatory system. We are working diligently in support of a reform that addresses efficiency, innovation and governance, all while maintaining the regulations’ high level of device safety and performance.
MedTech Europe has developed many resources in support of the reforms to the EU medical technology regulations, which cover several central areas for improvement:
You can access these and additional MedTech Europe resources to support the reforms to the EU medical technology regulations in The Future of EU Medical Technology Regulatory System Library.
