- General information
- Registration as an IVD manufacturer
- Registration IVDs
- Notification form
- 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). This also takes into account the fact that the European database on medical device (Eudamed) is not fully yet functional. 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
IVD manufacturers can register with Eudamed in the « Actors » module. Registration is currently voluntary. The legal obligation to register in Eudamed will become effective 6 months after the Actor module is declared fully operational in the Official Journal of the EU.
Since registration in Eudamed is not yet compulsory, Belgian manufacturers and authorised representatives can still apply the corresponding IVDD provisions transposed into national legislation. However, the FAMHP strongly encourages you to register proactively now. In fact, Eudamed will be considered as the authentic source for the "actor" data of economic operators (manufacturers, authorised representatives and importers), and our online applications (the web portal) will communicate with Eudamed in order to retrieve this data. This means that registration on Eudamed will be considered as registration on our online applications.
Further information on registration and Eudamed can be found in our FAQ document (see point 7, question 3 to 5).
From 26 May 2022, IVDs placed on the market must comply with IVDR. However, IVDD-compliant IVDs benefiting from a transitional period (Article 110 IVDR and Regulation (EU) 2022/112) can continue to be placed on the market (see point 5)
Manufacturers can register their IVDs in Eudamed. The mandatory registration of IVDs in Eudamed will depend on the status of the device (MDR certified or not at the time Eudamed becomes mandatory, legacy devices, etc.). For more information, we invite you to consult the page dedicated to this subject.
Since registration in Eudamed is not yet compulsory, Belgian manufacturers and authorised representatives can still apply the corresponding IVDD provisions transposed into national legislation, namely notification to the FAMHP of placing an IVD on the market (see point 4). Nevertheless, the FAMHP is encouraging the Belgian manufacturers and the foreign manufacturers who have designated a Belgian authorised representative the registration of their IVD(s) on Eudamed via the "Devices" module. This registration replaces the FAMHP notification. No acknowledgement of receipt will be sent in this case. If you still wish to receive an acknowledgement of receipt, please contact us by e-mail at notifications.meddev@fagg-afmps.be with the following details:
- The manufacturer's SRN
- The authorised representative's SRN
- The basic UDI-ID
- The device model
- The number of the CE certificate and notified body (if applicable)
In accordance with Article 5 of the Royal Decree of 14 November 2001, Belgian manufacturers and authorised representatives who do not yet use Eudamed (see also points 2 and 3) must notify the FAMHP before placing IVDs on the market.
The notification must be made
- using the notification form for the placing on the market : form on IVDR (French/Dutch), form on IVDD (French/Dutch)
- on the day the devices are placed on the market at the latest,
- separately for each device.
The form can be completed using Microsoft Word or certain free alternatives such as WPS Office Writer. Please note that some alternatives (Open Office) do not display drop-down menus or allow fields to be completed correctly. The form must be signed manually after printing or signed electronically using a PDF reader.
The various documents can be send in electronic format by e-mail to notifications.meddev@afmps.be. If several notifications are being submitted made at the same time, please group the various documents to be supplied in a folder for each notification.
The confirmation of receipt that you will receive following notification in no way constitutes approval of the qualification and classification of the IVD(s) concerned or their conformity with the general safety and performance requirements described in Annex I of Regulation (EU) 2017/746 on medical devices for in vitro diagnostic.
Changing the notification information
If the information provided at the time of notification changes, you must inform us within 15 days using the applicable notification form for the placing on the market (see above). When the change concerns the transition from IVDD to IVDR notification for the same device, the manufacturer or its authorised representative must use the IVDR notification form and must indicate the IVDD notification number in the appropriate field of the form. This change is not considered as a change but as a new notification.
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.