MDR/IVDR revision: a regulatory system at a crossroads

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 cutting 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 attention given their importance to healthcare systems.