- General information
- Registration as a system or procedure pack producer
- Registration of systems and procedure packs
- Notification form
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."
System or procedure pack producers can register with Eudamed in the "Actors" module. Registration is voluntary. The legal obligation to register in Eudamed will become effective 6 months after Eudamed is fully functional. The FAMHP strongly encourages you to register proactively. This is because Eudamed will be considered the authentic source for the "actor" data of economic operators (manufacturers, authorised representatives, system or procedure pack producers and importers), and our database (the web portal) communicates with Eudamed to retrieve this data. This means that registration in Eudamed will be considered as registration in our web portal.
Questions and answers on actor registration in Eudamed
Producers can register their systems and procedure packs in Eudamed. This registration is currently voluntary. Compulsory registration of systems and kits, like any other device, in Eudamed will have to take place no later than 18 months after compulsory registration of economic operators in the "Actors" module (so a total of 24 months after Eudamed is fully operational = 6 months + 18 months).
However, as registration in Eudamed of both actors and devices is not yet compulsory, Belgian system and procedure pack producers and authorised represenatives can still apply the corresponding provisions of Directive 93/42/EC transposed into national legislation, namely notification of the placing on the market of a system or necessary to the FAMHP.
Nevertheless, the FAMHP now advises Belgian producers and producers outside the European Union with an authorised representative located in Belgium to register their systems and procedure packs on Eudamed via the "Devices" module. This registration replaces the FAMHP notification. No acknowledgement of receipt will be sent in this case. If you would still like an acknowledgement of receipt, please contact us by email at email@example.com and provide us with :
- the Actor ID producer
- the authorised representative's SRN (if applicable)
- the basic UDI-DI
- the model of the system or procedure pack required
- the number of the CE certificate and notified body if applicable (sterile packaging of the system or procedure pack)
In accordance with Article 10 of the Royal Decree of 18 March 1999 (Fr/Nl), Belgian producers of system and procedure packs who do not yet use Eudamed (see also points 2 and 3) must notify the FAMHP before placing their system or procedure pack on the market. The notification must be made:
- using the notification form for the placing on the market (Fr/Nl)
- on the day the system/procedure packs are placed on the market at the latest
- separately for each system/procedure pack
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 firstname.lastname@example.org. 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 devices/system/procedure pack concerned or their conformity with the general safety and performance requirements described in Annex I of Regulation (EU) 2017/745 on medical devices.
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).
Guidance for medical devices is available on the European Commission’s website.