REGULATION
MDR/IVDR revision: a regulatory system at a crossroads
The European Commission’s targeted revision proposal of the EU Medical Devices Regulation and In Vitro Diagnostic Regulation aims to bring urgently needed reforms to increase patient protection and trust in medical technologies. Here, trade association MedTech Europe assesses the changes.
Europe’s regulatory framework for medical technologies is at a decisive moment. MedTech Europe fully supports the European Commission’s objective to streamline the EU regulatory system for medical devices and in vitro diagnostics – and urges Parliament and Council to deliver on an improved system swiftly. MedTech Europe broadly welcomes
the Commission’s push to optimise the regulatory system by reducing unpredictability and administrative duplication. Specific measures on open-ended certificates, streamlined change control and digitalised processes maintain high levels of patient safety
while meaningfully cuting unnecessary red tape. The proposed chapter on international regulatory cooperation is also a timely step to reinforce global reliance on the CE mark. However, in several areas, the
legislative text as drafted does not yet fully deliver on the proposal’s own stated ambition. Without targeted safeguards, there is a risk that positive reforms will be diluted through inconsistent implementation, regulatory overlap or insufficient operational detail. MedTech Europe, therefore, identifies a focused set of areas requiring strengthening: innovation pathways need to be more
effective, the integration of artificial intelligence requirements demands greater legal clarity, and performance study rules for in vitro diagnostics risk creating unnecessary process burdens. The association also cautions that the In Vitro Diagnostic Regulation (IVDR) amendments have so far received insufficient atention given their importance to healthcare systems. On one point, MedTech Europe urges
co-legislators to fundamentally reconsider. The proposal to introduce a ‘reusable- by-default’ presumption for single-use devices would add regulatory complexity without clear benefits for patients and would depart from established safety principles applied in regulatory systems worldwide.
A system at a crossroads The Medical Devices Regulation (MDR) and IVDR were designed to raise the bar for patient protection and strengthen trust in medical technologies. Yet nearly a decade into implementation, the very goals these regulations were meant to achieve are being undermined by structural shortcomings: slow and unpredictable conformity assessment timelines, disproportionate and costly administrative burdens, and inconsistent interpretation across Member States. The Commission’s proposal addresses
Despite reform, MedTech Europe still believes performance study rules for in vitro diagnostics risk creating unnecessary process burdens.
many of these challenges head-on. MedTech Europe’s assessment is clear: We strongly welcome the core direction on simplification and international
August 2026
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