On 25 April 2024, the European Parliament voted in favour of the Proposal on a gradual roll-out of EUDAMED, information obligation in case of interruption of supply, and the transitional provisions for certain in vitro diagnostic medical devices. These amendments to Regulations (EU) 2017/745 and (EU) 2017/746, the MDR and IVDR, will have a significant impact on manufacturers of medical devices and IVDs.
Gradual roll-out of EUDAMED
The initial plan was to launch EUDAMED and make it mandatory only once all six modules of the database were fully functional. With the latest changes, the official launch of EUDAMED will occur gradually. The first modules could become mandatory soon after they are available, audited, and declared functional. Presently, this is foreseen already by the end of 2025.
The new EUDAMED roll-out plan also brings some changes in the current EU scenario for registration. Currently, some Member States require an additional registration according to their national laws. The amendments to the MDR and IVDR aim to introduce one registration only – the EUDAMED registration – which will replace the single national registrations. Manufacturers will still have to comply with national requirements, such as language requirements and other local particularities.
Information obligation in case of supply interruption
Some of the most discussed topics since the application of the MDR and IVDR have been the risks related to a drop in the medical devices supply on the EU market and related threats to patients’ safety. The complex requirements of the new regulations have lead several manufacturers to leave the EU market, as some recent surveys show.
To prevent any threats to public or patients’ health, manufacturers will be obliged to inform the competent authorities and health institutions before they stop, either temporarily or permanently, to supply a critical medical device or IVD medical device.
New transitional provision for legacy IVDs
According to Article 110 of the IVDR, the transitional period for legacy devices was supposed to end on 26 May 2025. With the Commission’s Proposal, the amended Regulation foresees a longer transitional period, similar to the MDR extended transitional period. The new deadlines for legacy IVD devices are:
- 31 December 2027 for Class D and for devices covered by an IVDD CE Certificate
- 31 December 2028 for Class C
- 31 December 2029 for Class B and A sterile
Most importantly, manufacturers of legacy devices can be subject to this extended period only if they will have a notified body application and an IVDR-compliant Quality Management System by 26 May 2025, in addition to the general requirements for legacy devices.
Non-EU based manufacturers of legacy devices will need to have a mandate in place issued under the IVDR with their Authorised Representative, as the agreement issued under the Directive is void already from May 2022. Thus, this applies to regular devices (IVDs that are classified under IVDR as Class A and need to comply with the IVDR in full from May 2022) as well as devices which are certified under the Directive and meet the requirements for legacy devices that enjoy extra time.
Legacy review and EUDAMED registration
Your authorised representative plays a crucial role in verifying your compliance with the latest MDR and IVDR changes. Obelis can assist you with:
- Legacy review for IVDs and medical devices
- Actor registration and device registration on EUDAMED
- Notified body application
- Quality Management System for medical devices
Contact us to receive more information.
Get in touch with us today to learn more about how Obelis can assist you.
Simona Varrella
Expert Consultant at RII department
25.04.2024
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