At the end of January 2024, the European Commission published a Proposal to extend the legacy period for in-vitro diagnostic medical devices under the In Vitro Diagnostic Medical Devices Regulation (IVDR). Legacy IVD medical devices are medical devices that either a) were certified by a notified body before May 26, 2022, i.e., under the Direcetive, or b) needs the involvement of a notified body under the Regulation, which was not required under the Directive. Currently, the Proposal is under negotiations by the Parliament and the Council, which means that it is not yet official.
Impact of new legacy period for IVDs manufacturers
The Proposal aims at avoiding shortages of IVDs on the EU market, especially for class D IVDs. To prevent this, manufacturers are given a longer transition period to comply with the IVDR. Already in March 2023, the EU adopted a significant change to the IVDR by removing the “sell off” provision. The “sell off” provision imposed the market removal within a specific date of devices compliant with the Directives and lawfully placed on the EU market before the IVDR.
If the proposed text will be accepted, the new legacy period will be:
- 31 December 2027 for Class D
- 31 December 2028 for Class C
- 31 December 2029 for Class B & A sterile
As for the MDR extension, the new IVDR legacy period will not be automatic and will apply only if the manufacturer is taking the steps to comply with the IVDR. The main requirements are submitting an application with a notified body, and having an IVDR-compliant QMS by 26 May 2025.
Compliance with IVDR for IVDD compliant manufacturers
The new extension will apply only for compliant legacy devices. This means that IVD manufacturers of legacy devices would have to:
- Undergo a legacy review and have a QMS compliant with the Regulation, and not the Directive. Therefore, non-manufacturers need a mandate with their Authorised Representative issued under the IVDR.
- Submit an IVDR application with a notified body by May 2025.
One of the main challenges in the IVDR transition is the low number of notified bodies. As of February 2024, the total number of IVDR notified bodies added up to 12. In addition to this low number, manufacturers are unprepared for the Regulation requirements, leading to a significant percentage of applications being rejected, prolonging the overall transition. Consequently, manufacturers should act fast and approach a notified body as soon as possible, as the certification process (QMS and product certification) lasts 13 to 18 months on average.
Prior notice to avoid shortages and EUDAMED role in the Single Market
Together with the new transitional period, the European Commission also proposed two important steps to avoid shortages of medical devices and IVDs and strengthen the Single Market. To foresee any possible market disruptions, manufacturers would be required to inform competent authorities and health institutions before they stop, temporarily or permanently, the supply of a critical device. The second step envisages the removal of national registrations to be replaced by only one mandatory registration, performed on the European database for medical devices EUDAMED. In regards to EUDAMED, the Commission intends the introduce the mandatory use of EUDAMED gradually, starting with the modules which are functional and audited.
As your authorised representative, Obelis prepares EU and non-EU manufacturers for the transition towards the Regulation and verifies your compliance with the essential requirements for a smooth market access. Get in touch with us today to know more about European regulatory requirements.
Simona Varrella
Regulatory Intelligence & Innovation
19.02.2024
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