- General information
- Registration as an IVD manufacturer
- Registration IVDs
- Transitional period
- Guidance
- FAQ
In general, from 26 May 2022, IVDs must comply with the new IVD Regulation (Regulation (EU) 2017/746 on in vitro diagnostic medical devices, hereafter abbreviated as IVDR). However, there are still some transitional periods and exceptions in place, allowing IVDs to be placed on the market under the previous IVD legislation (Directive 98/79/EC, hereafter abbreviated as IVDD) (see point 5). IVD manufacturers must comply with the general obligations set out in Article 10 of the IVDR, subject to their applicability to IVDs benefiting from a transitional period.
2. Registration as an IVD manufacturer
Regulation (EU) 2017/746 (IVDR) requires manufacturers of in vitro diagnostic medical devices to register in the “Actors” module of EUDAMED, the European database on medical devices. This registration is mandatory since 28 May 2026.
The FAMHP asks you to register. Since 28 May 2026, EUDAMED is considered the sole authentic source for the “actor data” of economic operators (manufacturers, authorized representatives and importers). Our database (the web portal) communicates with EUDAMED in order to automatically retrieve these data. It is therefore no longer necessary to register on the FAMHP web portal; only registration in EUDAMED is required.
Further information on registration and Eudamed can be found in our FAQ document.
Questions and answers on the registration of actors in EUDAMED.
More information on EUDAMED (European Commission website).
Regulation (EU) 2017/746 on in vitro diagnostic medical devices requires manufacturers to register their IVDs in the “Devices” module of EUDAMED. Registration is mandatory since 28 May 2026, with a transitional period applying only to certain types of devices. For more information on this subject, please consult the dedicated page on our website.
It is therefore no longer necessary to register on the FAMHP web portal; only registration in EUDAMED is required. No acknowledgement of receipt can be issued by the FAMHP.
Some IVDs may benefit from a transitional period under certain conditions (Article 110, IVDR). During that period, it is still possible to place on the market IVDs that are compliant with the old IVD Directive after 26 May 2022 (the date of application of the new IVDR). These IVDs are termed 'legacy IVDs'.
- In January 2022, a first amendement to the IVDR transitional provisions was published with the following points :
- extension of the maximum validity date of IVDD certificates to 26 May 2025 (instead of 26 May 2024);
- extension of the transition period for IVDs with a valid IVDD certificate until 26 May 2025 (instead of 26 May 2024);
- addition of transitional periods for 'other' IVDs that are not certified under IVDD but for which certification is required under IVDR.
- A second amendement to the IVDR transitional provisions was published beginning of 2023. It removes the deadlines for IVDD-compliant IVDs already in the distribution chain. Once these IVDD-compliant IVDs are in the distribution chain, they can continue to be supplied to customers.
- Finally, a third amendment was published in June 2024, which once again changes the transitional periods and imposes additional conditions on manufacturers to benefit from these transitional periods.
Further information on the transitional periods can be found in question 8 of the FAQ document (see point 7).
The European Commission publishes guidance documents on many subjects (UDI, Eudamed, nomenclature, notified bodies, legacy devices, etc.). These guidance documents are available via this link. It also publishes more general information on topics of interest (notified bodies, standards, expert panels, Eudamed, etc.).
The FAMHP has produced a FAQ document for IVD manufacturers and authorised representatives with information on: Eudamed, the single registration number for Eudamed, UDI, availability of European reference laboratories, transitional provisions, etc.