MDR/IVDR revision: Building a simpler, more predictable framework for patient access and innovation
Posted on 05.05.2026
Europe’s regulatory framework for medical technologies is at a pivotal moment. Nearly a decade after adoption, the implementation of the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulations (IVDR) has revealed structural challenges: slow and unpredictable conformity assessment timelines, a high administrative burden, and divergent interpretations across Member States. These issues are affecting patient access to technologies, the availability of certain devices and diagnostics, and Europe’s attractiveness for investment.
MedTech Europe welcomes the European Commission’s proposal as a strong basis for reform. The focus on simplification and international cooperation is particularly important. Moving towards risk-based oversight, streamlining procedures, and advancing digitalisation can reduce unnecessary complexity and allow authorities and notified bodies to focus on what matters most: where risks truly lie. Strengthening international cooperation through initiatives such as the Medical Device Single Audit Programme (MDSAP) is essential to increase the attractiveness of the EU market.
At the same time, targeted improvements are needed to ensure the proposal delivers in practice. The proposed breakthrough and orphan device pathways require targeted refinements to reach their full potential. This includes explicitly covering paediatric devices under Article 52a MDR and aligning the IVDR orphan device definition with the EU rare disease threshold. The integration of artificial intelligence requirements into a single MDR/IVDR conformity assessment pathway should be accompanied by a clear and timely implementation process. Proportionate approaches are also needed in areas such as cybersecurity reporting and performance studies, to avoid unnecessary burden while maintaining robust safeguards.
Finally, the proposed approach to the reprocessing of single-use devices should be reconsidered. Single-use devices are specifically designed for one-time use, and this is fundamental to their safety profile. The current proposal should be rebalanced so that reuse is assessed based on risk, with full manufacturer responsibilities clearly assigned to any entity refurbishing such devices.
Ultimately, a simpler and more predictable system is not a shortcut on safety. It is the condition for safety, for timely patient access, and for Europe’s long-term competitiveness. With targeted refinements, the MDR/IVDR revision can deliver a framework that works better for patients, healthcare systems and innovation across Europe.
Read our full position on the MDR and IVDR revision below.