- General information
- Registration as a manufacturer of class I devices
- Registration of class I devices
- 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) requires medical device manufacturers to register in the “Actors” module of EUDAMED, the European database on medical devices. This registration is mandatory since 28 May 2026.
The FAMHP requests 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.
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 class I devices 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.
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.