- General information
- Registration as a system or procedure pack producer
- Registration of systems and procedure packs
- Guidance
Regulation 2017/745 (Art. 2) defines systems and procedure packs as follows:
- Procedure pack : a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose.
- System : a combination of products, either packaged together or not, which are intended to be inter-connected or combined to achieve a specific medical purpose.
Some products may fall under both definitions.
Systems and procedure packs can consist of several devices but also of a device and a "non-medical device" product.
In this case, Regulation 2017/745 (Art. 22) sets out that :
« Natural or legal persons shall draw up a statement if they combine devices bearing a CE marking with the following other devices or products, in a manner that is compatible with the intended purpose of the devices or other products and within the limits of use specified by their manufacturers, in order to place them on the market as a system or procedure pack:
a) other devices bearing the CE marking;
b) in vitro diagnostic medical devices bearing the CE marking in conformity with Regulation (EU) 2017/746;
c) other products which are in conformity with the legislation that applies to those products only where they are used within a medical procedure or their presence in the system or procedure pack is otherwise justified."
2. Registration as a system or procedure pack producer
Since 28 May 2026, producers of systems and procedure packs must register in EUDAMED in the “Actors” module.
EUDAMED is considered the sole authentic source for the “actor data” of economic operators (manufacturers, authorized representatives and importers), and 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.
Questions and answers on actor registration in Eudamed
For more information on Eudamed.
3. Registration of systems and procedure packs
Since 28 May 2026, producers of systems and procedure packs must register their systems and procedure packs in EUDAMED. For certain types of devices, a transitional period applies. For more information on this subject, please consult the dedicated page on our website.
It is therefore no longer necessary to register them on the FAMHP web portal; only registration in EUDAMED is required. No acknowledgement of receipt can be issued by the FAMHP.
Guidance for medical devices is available on the European Commission’s website.