- 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. However, a distinction must be made between class I devices that do not require the intervention of a notified body and class I sterile (Is), measuring (Im) medical devices and class I reusable surgical instruments (Ir). These three categories must also be certified by 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
In general, from 26 May 2021, all class I devices must comply with the new Regulation (Regulation (EU) 2017/745 on devices, hereafter abbreviated to "MDR"). However, certain class I devices benefit from a transition period under certain conditions (class I sterile and/or measuring devices, devices that move into a higher risk class as well as reusable surgical instruments).
This also takes into account the fact that the European medical device database (Eudamed) is not fully operational and that the various Eudamed modules will gradually be made mandatory. For more information on the subject, please consult the specific page on this subject (put hyperlink). Manufacturers of class I devices must comply with the general obligations set out in Article 10 of the MDR, with the exception of devices for which a transition period applies. This compliance with the requirements of the regulation is established by the manufacturer in the EU Declaration of Conformity (Article 19 of the MDR).
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 have an authorised representative within the European Union.
2. Registration as a manufacturer of class I devices
Manufacturers of class I devices 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.
However, the FAMHP strongly encourages you to register proactively. In fact, Eudamed will be considered as the authentic source for the "actor" data of economic operators (manufacturers, authorised representative and importers), and our database (the web portal) communicates with Eudamed in order to retrieve this data. This means that registration on Eudamed will be considered as registration on our web portal.
Frequently Asked Questions on actor registration in Eudamed
For more information on Eudamed.
3. Registration of class I devices
Manufacturers can register their devices in Eudamed. This registration is currently voluntary. Mandatory registration of devices in Eudamed must be carried out no later than 6 months after the date of notification in the Official Journal of the EU that Eudamed is functional (currently planned for Q2 2025).
Since the registration of actors and devices in Eudamed is still not yet compulsory, Belgian manufacturers and authorised representative can still apply the corresponding provisions of Directive 93/42/EC transposed into national legislation, i.e. notification to the FAMHP of placing a class I device on the market.
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 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 (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.
In accordance with Article 10 of the Royal Decree of 18 March 1999, manufacturers and authorised representative who do not yet use 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 benefit from a transition period under certain conditions (class I sterile and/or measuring devices, devices that move into a higher risk class as well as reusable surgical instruments). These conditions are described in Article 120, point 3 of Regulation (EU) 2017/745.
The other class I devices must have complied with Regulation (EU) 2017/745 since 26 May 2021. They must therefore be notified to the FAMHP or registered on Eudamed.
For more information, see the frequently asked questions for class I manufacturers.
Guidelines for class I medical devices are available on the European Commission website:
- MDCG 2020-2 rev. 1 Class I Transitional provisions under Article 120 (3 and 4) – (MDR),
- MDCG 2019-15 rev.1 Guidance notes for manufacturers of class I medical devices.
The FAMHP has drawn up an FAQ document for manufacturers of class I devices.