MedTech Europe‘s post-EPSCO statement on the necessary reforms of MDR/IVDR

Posted on 04.12.2024

At the 3 December 2024 Health Council (EPSCO) meeting, many EU Member States highlighted the pressing need to reform the EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). Certification delays, regulatory bottlenecks, and burdens on SMEs are putting innovation, patient safety, and healthcare access at risk.

MedTech Europe fully supports the calls for action and urges the European Commission to deliver both immediate measures and comprehensive reforms. Short-term actions like faster certification processes, streamlined assessments, and adapting certification to the device lifecycle are critical to addressing current challenges.

Longer-term, sustainable measures to decrease bureaucratic burden, increase system efficiency, fast-tracking innovation and introducing a unified, sector-specific governance model are needed to support innovation and maintain high safety standards.

MedTech Europe is ready to collaborate with policymakers and stakeholders to ensure an efficient, innovation-friendly regulatory framework. Together, we can safeguard public health and Europe’s global leadership in medical technologies.

Read our full statement below.