Adoption of Proposal for IVDR Delay and Eudamed Obligations

The European Parliament has successfully endorsed a proposal by the European Commission put forward in January 2024 which aimed to delay the application of the EU In-Vitro Diagnostic Regulation (IVDR) and speed up the implementation of EUDAMED.

Access to IVDs, including tests for HIV or hepatitis, is vital for patients. A significant portion of IVDs presently available do not meet the EU regulations that have been in effect since May 2022. The accepted proposal provides additional time for manufacturers to adapt to the updated requirements under specific conditions, ensuring safety is not compromised and helping to alleviate the risk of shortages.

The extension of time allotted to companies varies according to the classification of the device:

  • Devices with high individual and public health risks, such as HIV or hepatitis tests (class D), will undergo a transition period until December 2027.
  • Devices with high individual and/or moderate public health risks, such as cancer tests (class C), will undergo a transition period until December 2028.
  • Devices with lower risks (class B), such as pregnancy tests, and sterile devices (class A), such as blood collection tubes, will have a transition period until December 2029.

Manufacturers are required to provide advance notice in the event of anticipated supply disruptions for specific IVDs or medical devices. This notification must be issued six months prior to the disruption to competent authorities, distributors, and healthcare providers. Such proactive communication ensures ample time for necessary measures to be taken to safeguard patient care.

With respect to Eudamed, the agreement by the Parliament will facilitate the launch of several modules. From the beginning of 2026, it is expected that the use of these modules will become mandatory.