REGULATION
Because the Commission’s proposal revises MDR and IVDR in a single legislative package, there is a real risk that IVD-specific amendments receive less scrutiny.
cooperation – measures that, if preserved and reinforced, will make a tangible difference for patients and industry alike. We call for targeted strengthening of several provisions where the proposal’s ambition risks being undermined by implementation gaps – including making the innovation pathways more fit-for-purpose, ensuring AI Act requirements are reflected in a time-bound manner, and avoiding unintended red tape for IVD performance studies. We urge a fundamental rethink of the approach to reprocessing of single-use devices, where the proposed ‘reusable by default’ presumption adds unclear administrative burden for most single-use devices and departs from established safety principles.
The cost of delay is concrete and cumulative. Every month without simplification is a month in which manufacturers continue to redirect investment away from Europe, patients face avoidable disruptions to the technologies they depend on, and the EU falls further behind competing jurisdictions as a destination for regulatory approvals. These are not hypothetical risks, they are already happening, and they accelerate the longer the process takes. The window to act is now; this process should not take years. In vitro diagnostics deserve equal
atention in this process. IVDs play a critical role in health systems: they inform diagnosis, guide treatment decisions and underpin public health surveillance. Because the Commission’s proposal revises MDR and IVDR in a single legislative package, there is a real risk that IVD-
specific amendments receive less scrutiny. Parliament and Council must ensure that the rules shaping Europe’s access to diagnostic technologies for decades to come are given the focus they require. Parliament and Council now have both the opportunity, and the obligation, to steer the system swiftly back on track. The Commission’s proposal provides a solid basis. Much of it deserves strong support; some elements need targeted safeguards.
Welcome: what the proposal gets right
Nearly nine years of MDR and IVDR implementation have exposed structural shortcomings, but have also given regulators the practical experience to understand how the system can work more efficiently without compromising safety. Key measures designed to simplify the regulations, strongly supported by MedTech Europe include: Open-validity certificates with periodic risk-based reviews: removing fixed five- year recertification cycles eliminates an artificial botleneck while maintaining ongoing oversight proportionate to the device’s risk profile. Streamlined change control: clearer distinction between product changes
manufacturers can implement without prior notification and those requiring approval. Risk-based sampling in conformity assessment: proportionate scrutiny for lower- and medium-risk devices removes duplicative procedural steps Broader recognition of clinical evidence: explicit recognition of well-established technologies, and acceptance of non- clinical evidence including modelling and simulation. Proportionate treatment of near- patient IVD tests: aligning the regulatory pathway for near-patient tests with other professional-use diagnostics. Digitalisation: electronic submission of technical files, digital EU declarations of conformity, digital labelling and digital provision of information to healthcare professionals and patients.
Simplified and more targeted rules allow all actors in the system to focus atention where it maters most: where there is risk. Reducing administrative ‘noise’ makes it easier to identify genuine safety signals sooner. Oversight is ensured through ongoing surveillance, annual audits and pre-approval of substantial changes by notified bodies, and strengthened coordination of market surveillance authorities. A modernised, streamlined regulatory system is the condition for safety and ensuring that safe and effective products reach patients in a timely way. The proposed International Cooperation
chapter is a critical and timely addition to the EU’s regulatory framework for medical devices, advancing EU regulatory, strategic, and competitiveness interests. Medical technologies are developed, manufactured and used on a global scale. Stronger regulatory cooperation reinforces the international reliance on the CE mark, helping EU-based companies, particularly SMEs, access new markets. It also reduces duplication, lowers costs and accelerates patient access without compromising safety. The Medical Devices Single Audit Programme (MDSAP) allows a single quality management system audit to satisfy the requirements of multiple jurisdictions. Full EU membership in
Full EU membership of the Medical Devices
Single Audit Programme is essential to capture the full benefits of reliance and increase the attractiveness of the EU market
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WWW.PATHOLOGYINPRACTICE.COM August 2026
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