The Belgian competent authority (AFMPS/FAGG) has updated the form for the Free Sales Certificates (FSC) under the Medical Devices Regulation 2017/745 (MDR) and the In Vitro Diagnostic Devices Regulation 2017/746 (IVDR).
What is a Free Sales Certificate?
A Free Sales Certificate (or Free Trade Certificate) is a legalized document provided by the competent authority of an EU member state. The Free Sales Certificate is a confirmation that the devices sold by the manufacturer are CE marked and can be placed in the EU market. Due to the high standards, the European Union sets under its Medical Devices Regulations, the certificate is used by manufacturers to speed up their entry procedures in non-EU markets.
What are the main elements of the new FSCs?
The new Free Sales Certificates form requests crucial information from the manufacturer:
- Basic UDI-DI of each device part of the FSC (not needed for legacy devices);
- Notification number (in case of Class I devices & IVDs);
- Device name linked to the Basic UDI-DI or Notification number;
- Manufacturer’s name and address;
- Manufacturer’s authorised representative (applicable only for non-EU manufacturers)
- Manufacturer’s VAT number;
- Manufacturer’s CE Certificate (if applicable);
- Manufacturers ISO 9001/EN 13485 Certificate (if applicable);
Additionally, the manufacturer needs to answer questions concerning the existence of medicinal substances or cells or tissues of human origin, among others.
The Belgian competent authority has indicated that these new FSC are currently applicable also for legacy devices. FSCs issued under the old forms are no longer accepted.
How can Obelis support you?
For non-EU manufacturers, it is the authorized representative such as Obelis that requests the competent authority to issue the FSC. It is now possible that Obelis, as regulatory consultant, apply for an FSC even for EU-based companies.
Publications department
17.10.2023
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