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Press Release New medtech regulations

Adopted amendments to IVDR/MDR: more measures still needed to ensure that existing and new medical technologies reach patients and health systems

Posted on 30.05.2024

Brussels, 30 May 2024 – Today marks the political adoption by the EU co-legislators of an amendment to the In Vitro Diagnostics and Medical Devices Regulations (IVDR and MDR). This amendment includes an extension to the IVDR transitional provisions and a significant new notification requirement for critical devices. It also enables earlier use of certain European medical devices database (EUDAMED) modules.

MedTech Europe remains committed to making the IVDR and MDR a success, and we continue to actively encourage all manufacturers who place medical technologies on the EU market to apply promptly for certification to ensure patients’ access to safe and performing medical technologies. At the same time, major challenges persist in the system. While we acknowledge the adoption of the latest measures, we believe it’s time to address the root causes that have led to this 4th extension of the medical technology regulations. Going forward, we need comprehensive changes to both IVDR and MDR to keep innovative medical technologies available for all“, said Oliver Bisazza, CEO of MedTech Europe.

Extension of the IVD Regulation transitional periods
The extended timeline will support existing IVD medical tests that require additional time to transition. However, the many existing and new medical tests that are not transitioning to the IVDR − due to its slow conformity assessment timelines and resource-intensive requirements − remain unaided by the amendment. The European Commission and Medical Devices Coordination Group should address these issues as soon as possible. A sharp reduction in administrative requirements , plus shorter and more predictable assessment timelines, would immediately help.

Notification of interruptions of supply
The amendment requires manufacturers to notify their Competent Authority, supply chain partners, and customers six months before any device supply disruption that could pose serious harm to patients or public health. While the industry supports the intention, this requirement needs to be proportionally scoped and executed efficiently and should only apply to situations where the interruption lasts at least 90 days. Last but not least, reporting at the EU level should supersede any national reporting requirements that have been or are planned to be implemented.

Early mandatory use of EUDAMED
MedTech Europe welcomes the early mandatory use of certain EUDAMED modules, provided important preconditions are met: the modules must be fully developed, tested, and ready for practical implementation. User onboarding and training for accessing the playground and the database must be available. EUDAMED also needs to enable the most efficient use of Notified Body and Manufacturer resources, requiring improvements in usability and functionality. Pragmatic timelines and the elimination of redundancy in national databases are imperative for a seamless transition.

About MedTech Europe

MedTech Europe is the European trade association for the medical technology industry including diagnostics, medical devices, and digital health. Our members are national, European, and multinational companies as well as a network of national medical technology associations who research, develop, manufacture, distribute, and supply health-related technologies, services, and solutions.

For more information, please contact:

Miriam D’Ambrosio
Senior Manager Communications
MedTech Europe
[email protected]