- General information
- Registration as an IVD manufacturer
- Registration IVDs
- Notification form
- Transitional period
1. General information
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 to "IVDR"). However, there are still some transitional periods and exceptions in place, allowing IVDs to be marketed under previous IVD legislation (Directive 98/79/EC, hereafter abbreviated to "IVDD") (see point 5). This also takes into account the fact that the European database on medical device (Eudamed) was not fully functional on 26 May 2022. 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 on Eudamed will become effective 6 months after Eudamed is fully functional.
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.
3. Registration IVDs
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. This registration is currently voluntary. IVDs must be registered in Eudamed no later than 18 months after the compulsory registration of economic operators in the "Actors" module (so a total of 24 months after Eudamed is fully operational = 6 months + 18 months).
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 foregin 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 firstname.lastname@example.org 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)
4. Notification form
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 email@example.com. 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 fiel of the form. This change is not considred as a change but as a new notification.
5. Transitional period
Some IVDs may benefit from a transitional period under certain conditions (Article 110, IVDR). As a result, a first amendement to the IVDR transitional provisions was published in January 2022 with the following pointss :
- 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 in early 2023. It removes the deadlines for IVDD-compliant IVDs already in the distribution chain. Once these directive-compliant IVDs are in the distribution chain, they can continue to be supplied to customers.
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.