On 23 January 2024, the European Commission published a Proposal to extend the IVDs legacy period and make EUDAMED mandatory earlier than planned. With this Proposal, the Commission took additional steps to ensure medical devices’ availability and give the industry a longer transition period. To prevent any supply chain interruptions and a public health crisis, the Medical Devices Regulation and IVD Medical Devices Regulation (MDR and IVDR) will be likely newly subject to amendments.
Proposed transitional periods for IVDs
One of the most significant challenges introduced by the IVDR is the increased involvement of notified bodies for the device’s conformity assessment, with about 80% of all IVDs requiring a notified body. With the current deadlines for legacy devices approaching, many certificates expiring, and a low number of IVDs certified under the IVDR, additional transition time is necessary to solve the following issues:
- A low number of notified bodies designated under the IVDR (only 12 as of 23 January 2024)
- Unpreparedness of manufacturers to demonstrate compliance with the requirements of the IVDR
- SMEs’ lack of resources for the transition
This additional transition period is essential in particular for class D IVDs, high-risk devices to test for infections, for life-threatening infectious diseases, or for blood grouping for transfusions.
The proposed extra time will depend on the risk class.:
- 31 December 2027 for Class D
- 31 December 2028 for Class C
- 31 December 2029 for Class B & A sterile
This prolonged legacy period will apply only if the manufacturer is taking the necessary steps towards the IVDR transition, such as approaching a notified body, and having an IVDR-compliant QMS by 26 May 2025.
EUDAMED modules to become gradually mandatory
The Proposal includes important steps for the implementation of the European database EUDAMED. The Commission is aiming at enabling the mandatory use of EUDAMED modules gradually as they become available, audited, and declared functional. Currently, three modules are available: Actors, UDI/Devices, and Notified Bodies/Certificates. In the second quarter of 2024, the modules dedicated to market surveillance/post-market surveillance and vigilance are expected to function, too. Consequently, mandatory use of several modules could start already in the last quarter of 2025.
Importantly, the Proposal indicates that national registrations will be replaced by a single registration to EUDAMED.
Prior notice if the supply of certain medical devices stops
In some cases, the interruption of the supply of medical devices can have serious consequences and represent a threat to public or patients’ health. The Proposal includes provisions obliging manufacturers to inform the relevant competent authorities and health institutions before they stop, temporarily or permanently, the supply of a critical device.
The Proposal will now have to be subject to negotiations of the Parliament and the Council. Once the final text has been adopted, it will be published in the Official Journal of the EU and become official.
Do you want to know more about the IVDR and MDR transitional period? Contact us now!