MedTech Europe has published a position paper outlining its views on the proposed revision of the European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR).
According to MedTech Europe, the European regulatory framework for medical technologies has reached a critical stage. The organisation supports the European Commission’s efforts to streamline and improve the EU regulatory system for medical devices and in vitro diagnostics (IVDs), while calling on the European Parliament and Council to implement meaningful reforms without delay.
While the MDR and IVDR were introduced to strengthen patient safety and increase confidence in medical technologies, MedTech Europe argues that several structural challenges have emerged during implementation. These include lengthy and unpredictable conformity assessment timelines, significant administrative burdens, high compliance costs, and inconsistent regulatory interpretation across EU Member States. The organisation believes these issues are undermining the original objectives of the regulations.
In its assessment of the Commission’s proposal, MedTech Europe:
- Welcomes the overall direction of the proposed reforms, particularly measures aimed at simplifying regulatory processes and enhancing international cooperation, which it believes will benefit both patients and industry.
- Calls for further strengthening of certain provisions to ensure effective implementation, including improvements to innovation pathways, timely alignment with requirements under the AI Act, and the avoidance of unnecessary regulatory burdens for IVD performance studies.
- Advocates a reconsideration of the proposed approach to the reprocessing of single-use devices, expressing concerns that a “reusable by default” presumption could create additional administrative complexity and deviate from established safety principles.
MedTech Europe also highlights the economic and healthcare consequences of delayed reform. The organisation warns that ongoing regulatory inefficiencies are already contributing to reduced investment in Europe, potential disruptions to patient access to medical technologies, and a decline in the EU’s competitiveness as a market for regulatory approvals and innovation.
The position paper further emphasises the importance of ensuring that IVD-specific issues receive sufficient attention during the legislative process. As the Commission’s proposal addresses both the MDR and IVDR within a single legislative package, MedTech Europe cautions that the unique needs and challenges of the diagnostics sector could be overlooked. Given the essential role IVDs play in diagnosis, treatment decisions, and public health monitoring, the organisation urges policymakers to ensure that revisions to the IVDR receive appropriate consideration.
MedTech Europe concludes that the European Parliament and Council have an important opportunity to improve the regulatory framework and address longstanding implementation challenges. While the organisation broadly supports the Commission’s proposal, it recommends targeted modifications to ensure that the revised regulations achieve their intended objectives while maintaining patient safety, fostering innovation, and supporting timely access to medical technologies across Europe.
The full position paper can be accessed using the following link
