- General information
- Registration as a manufacturer of class I devices
- Registration of class I devices
- Notification form
- Transition phase
- Guidance
- FAQ
Class I devices belong to the lowest risk class. Unlike higher-risk classes (IIa, IIb, III), the intervention of a notified body is not always required for placing them on the market and for the manufacturer to affix the CE marking. Only class I sterile (Is), measuring (Im) medical devices and class I reusable surgical instruments (Ir) require the intervention of a notified body.
For Im and Is, the intervention of the notified body is limited to the measurement function and/or sterility.
Reusable surgical instruments must be assessed by a notified body for aspects related to:
- The reuse of the device, in particularly cleaning, disinfection, sterilisation, maintenance and functional testing.
- The accompanying instructions for use.
To be placed on the market, all class I devices must comply with Regulation (EU) 2017/745 on medical devices (hereafter abbreviated to "MDR") which has been applicable since 26 May 2021. Compliance with the requirements of the regulation is established by the manufacturer in the EU Declaration of Conformity (Article 19 of the MDR). Manufacturers of Class I devices must also meet the obligations outlined in Article 10 of the MDR.
However, certain class I devices that comply with the previous legislation Directive 93/42/ECC on medical devices (hereinafter referred to as “MDD”) benefit from a transition period under certain conditions and may still be placed on the market without MDR compliance (see further details below).
Regardless of the type of class I device, the manufacturer must make the full technical documentation demonstrating the conformity of the device with the essential requirements in accordance with Directive 93/42/EEC or the general safety and performance requirements under Regulation (EU) 2017/745 available to the competent authorities.
In the event that the manufacturer is based outside the European Union, they must designate an authorised representative within the European Union.
2. Registration as a manufacturer of class I devices
Regulation (EU) 2017/745 (MDR) requests manufacturers of medical devices to register in the "Actors" module of Eudamed, the European database on medical devices. Before 28 May 2026, this registration is carried out on a voluntary basis. However, registration in Eudamed will be mandatory as from 28 May 2026, i.e. 6 months after the date of publication of Decision (EU) 2025/2371 concerning Eudamed. (more information on the "Eudamed" webpage).
The FAMHP strongly recommends to register proactively. On 28 May 2026, Eudamed will be considered as the only authentic source for the "actor" data of economic operators (manufacturers, authorised representatives and importers). Our national database (the web portal) communicates with Eudamed in order to retrieve these data. This means that registration in Eudamed will be equivalent to a registration on our web portal. After registration in Eudamed, it is requested to log in to the web portal to complete the risk class(es) of the devices you manufacture and to add additional establishment units.
Frequently Asked Questions on actor registration in Eudamed.
For more information on Eudamed (European Commission website).
3. Registration of class I devices
Regulation (EU) 2017/745 on medical devices requires manufacturers to register their medical devices of class I in the "Devices" module of Eudamed. At this time, this registration is done on a voluntary basis. The date on which the registration of a device becomes mandatory depends on several factors. With the publication on 27 November 2025 of Decision (EU) 2025/2371, the full functionality of the "Devices" module was confirmed. After a transitional period of 6 months, the registration of medical devices of class I will become mandatory in Eudamed as from 28 May 2026.. For more information on this subject, please consult the dedicated page on our website.
Before 28 May 2026, Belgian manufacturers and authorised representatives still have the possibility to apply the corresponding provisions of Directive 93/42/EEC as transposed into national legislation, namely the notification to the FAMHPof the placing on the market of a class I device (see the form below).
Nevertheless, the FAMHP encourages Belgian manufacturers and non-European Union manufacturers who have a Belgian authorised representative to register their device(s) in Eudamed through the "Devices" module. This registration replaces the notification to the FAMHP mentioned above. 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 (if applicable)
- The basic UDI-DI
- The device model
- Number of CE certificate and notified body for class I sterile devices, with measuring function or reusable surgical instruments.
Starting from 28 May 2026, notifications to the FAMHP will no longer be possible and registrations must be carried out exclusively via Eudamed. In addition, as from that date no acknowledgement of receipt will be issued by the AFMPS.
In accordance with Article 10 of the Royal Decree of 18 March 1999, manufacturers and authorised representative who have not yet registered their class I devices in Eudamed must notify the FAMHP before they place their class I device(s) on the market. The notification must be made:
- via the placing on the market notification form (the form is not available in English. Please use one of the following FR MDR form, NL MDR form, FR MDD form, NL MDD form),
- 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 certain alternatives (Open Office) will not display drop-down menus or allow you to fill in the fields correctly. The form must be signed manually after printing or electronically using a PDF reader.
The various documents can be sent electronically by email to notifications.meddev@afmps.be. If several notifications are made at the same time, please group the different documents to be provided in a folder for each notification.
The acknowledgement of receipt you will receive following the notification in no way constitutes approval of the qualification and the risk class of the devices concerned or their compliance with the general safety and performance requirements described in Annex I of Regulation (EU) 2017/745 on medical devices.
Modification of the information concerning notification
If the information provided at the time of notification changes, you must inform us within fifteen days using the applicable notification form for placing on the market (see above).
If the change concerns the transition from notification under Directive 93/42/EEC to notification under Regulation (EU) 2017/745 for the same device, the manufacturer or their authorised representative must use notification form under the Regulation (under the MDR) and must indicate the number of the notification under the Directive (under the MDD) in the relevant box on the form. This type of change from an MDD notification to an MDR notification is not considered a change but rather a new notification.
Certain class I devices that comply with the previous legislation (Directive 93/42/EEC on medical devices, hereinafter referred to as “MDD") benefit from a transitional period under certain specific conditions and may therefore be placed on the market without being fully compliant with the MDR. This applies to:
- Class I devices under the MDD that required the involvement of a notified body (Is, Im).
- Class I devices under the MDD that did not require the involvement of a notified body but do under the MDR (Ir, Class I devices that are reclassified into a higher risk class).
These conditions are described in Article 120, point 3 of Regulation (EU) 2017/745.
For these devices, only the MDR requirements related to post-market surveillance, vigilance, and registration of economic operators and devices apply (see MDCG 2021-25 guidance for more information). For further details on the requirements and the duration of the transitional period, please consult the dedicated page on our website (Fr/Nl).
The European Commission publishes guidance documents on a wide range of topics, including : UDI, Eudamed, nomenclature, Notified Bodies, legacy devices, and more. It also provides general information on topics of interest such as Notified Bodies, standards, expert groups, Eudamed, etc.
The FAMHP has drawn up an FAQ document for manufacturers of class I devices.