Europe
Extension of the IVD Regulation Transitional Periods
Brussels, 30 May 2024 – The EU co-legislators have adopted an amendment to the In Vitro Diagnostics and Medical Devices Regulations (IVDR and MDR), extending the IVDR transitional provisions and adding a notification requirement for critical devices. This (fourth!) extension supports existing IVD medical tests needing more 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.
Notification of Interruptions of Supply
Manufacturers must now notify relevant authorities and partners six months before any supply disruption that could harm patients or public health. MedTech Europe suggests this requirement should only apply to interruptions lasting at least 90 days and that EU-level reporting should override national requirements.
Early Mandatory Use of EUDAMED
MedTech Europe supports the early use of certain EUDAMED modules, provided they are fully developed, tested, and ready. Efficient resource use, user training, and eliminating redundant national databases are essential for a smooth transition.
Conclusion
MedTech Europe encourages manufacturers to apply for certification promptly but calls for comprehensive changes to IVDR and MDR to keep innovative medical technologies available for all.
Regulation – EU – 2024/1860