A free sale certificate (FSC) is a document certifying that the devices covered by the certificate bear the CE marking and may be lawfully placed on the market within the European Union. This document is used for export purposes to demonstrate to the authorities in third countries that the devices listed on the certificate comply with European requirements.
There are several types of free sale certificates, depending on European regulations* or national legislation**, based on the applicant’s role and the type of device.
| Role for the applicant | Type of device | Regulation of devices | Legal reference stated on the certificate |
|---|---|---|---|
| Authorised representative or manufacturer | Medical devices (MD) | Regulation (EU) 2017/745 | Article 60 of Regulation (EC) No 2017/745* |
| Directives 93/42/EC or 90/385/EC | Article 27/1 of the Law of 22 December 2020 on medicinal devices** | ||
| In vitro diagnostic medical devices (IVD) | Regulation (EU) 2017/746 | Article 55 of Regulation (EC) No 2017/746* | |
| Directive 98/79/EC | Article 22/1 of the Law of 15 June 2022 on in vitro diagnostic medical devices** | ||
| Distributor, importer, exporter | Medical devices (MD) | Regulation 2017/745 or Directive 93/42/EC or Directive 90/385/EC | Article 27/1 of the Law of 22 December 2020 on devices** |
| In vitro diagnostic medical devices (IVD) | Regulation 2017/746 or Directive 98/79/EC | Article 22/1 of the Law of 15 June 2022 on vitro diagnostic medical devices** |
No, a free sale certificate is intended for the export of devices outside the European Union. The CE marking allows free circulation of devices within the European Union, as well as in Norway, Iceland and Liechtenstein, as these countries are part of the European Economic Area (EEA). Although Turkey is not part of the EEA, it also recognises the CE marking for medical devices. It is the applicant’s responsibility to verify whether a free sale certificate required for the export of the devices to the intended country.
The Health Products Division of the FAMHP will process your application within five calendar weeks. The clock starts once the application is complete.
The applicant may be the authorised representative, the manufacturer, the distributor, the importer or the exporter. Its registered office must be in Belgium. The type of certificate and, consequently, the legal reference depend on the criteria listed in question 2.
Yes, a free sale certificate or an FSC is also known as a certificate of free sale.
The documentation required depends on its risk class and the applicable legislation (MDD or MDR).
- Declaration of conformity
- ISO 13485 certificate: 2016
- EC certificate (if applicable)
- MDD: EC Certificate/EC Design Examination Certificate
- MDR: EU Quality Management System Certificate/EU Technical Documentation Assessment Certificate
For medical devices covered by Directive 93/42/EEC that are subject to a transition period under article 120 of Regulation 2017/745:
- the manufacturer's declaration form
- Proof of a signed written agreement with a notified body for conformity assessment in accordance with Regulation 2017/745.
The documentation required depends on its risk class and the applicable legislation (IVDD or IVDR).
- Declaration of conformity
- ISO 13485 certificate: 2016
- EC certificate (if applicable)
- IVDD: EC Certificate/EC Design Examination Certificate
- IVDR: EU Quality Management System Certificate/EU Technical Documentation Assessment Certificate
For in vitro diagnostic medical devices (IVD) covered by Directive 98/79/EEC (IVDD) that are subject to a transition period under article 110 of Regulation 2017/746 (IVDR):
- the manufacturer's declaration form
- proof of the submission of a formal application for conformity assessment (IVDR) from
- 26 May 2025:
- IVD devices covered by an IVDD certificate (Annex II – Lists A and B, and IVDs for self-testing)
- IVD ‘other’ devices classified under the IVDD as D under the IVDR
- 26 May 2026:
- IVD ‘other’ devices under the IVDD classified as C under the IVDR
- 26 May 2027:
- IVD ‘other’ devices classified under the IVDD as B and A non-sterile in accordance with the IVDR
- proof of a signed written agreement with a notified body
- 26 September 2025
- IVD devices covered by an IVDD certificate (Annex II – Lists A and B, and IVDs for self-testing)
- IVD ‘other’ devices classified under the IVDD as D under the IVDR
- 26 September 2026
- IVD ‘other’ devices under the IVDD classified as C under the IVDR
- 26 September 2027
- IVD ‘other’ devices classified under the IVDD as B and A non-sterile in accordance with the IVDR
- Declaration of conformity
- ISO 13485 certificate: 2016
- EC certificate (if applicable)
- Directive 90/385/EEC, EC Certificate/EC Design Examination Certificate),
- MDR: EU Quality Management System Certificate/EU Technical Documentation Assessment
For medical devices covered by Directive 90/385/EEC that are subject to a transition period under article 120 of Regulation 2017/745:
- the manufacturer's declaration form;
- proof of a signed written agreement with a notified body for conformity assessment in accordance with Regulation 2017/745.
The notification number or the basic UDI-DI can be used to verify that the device covered by the certificate application has been correctly notified or registered.
For class I devices covered by Directive 93/42/EEC and in vitro diagnostic medical devices (IVD) covered by Directive 98/79/EC that are subject to a transition period:
- the notification number must be provided, as these devices were required to be notified to the FAMHP.
For devices covered by Regulations (EU) 2017/745 and 2017/746:
- if the device was placed on the market before 28 May 2026, the notification number must be provided, if available;
- if the device is registered in EUDAMED, the notification number is not required, but the FAMHP must be able to identify the device in EUDAMED (using the basic UDI-DI).
As of 28 May 2026, no new notifications will be accepted by the FAMHP. All devices must be registered with EUDAMED before they are placed on the market.
For devices placed on the market before 28 May 2026, the obligation to register in EUDAMED applies by 28 November 2026 at the latest. During this transition period, the FAMHP will accept either the notification number or proof that the device is registered in EUDAMED.
• For Class I devices covered by Regulation (EU) 2017/745 and IVDs covered by Regulation (EU) 2017/746:
- if the device was placed on the market after 28 May 2026: no notification to the FAMHP is required and you will receive the free sale certificate provided that the device is registered in EUDAMED;
- if the device was placed on the market before 28 May 2026: you will receive the free sale certificate provided that the device has been notified to the FAMHP or registered in EUDAMED;
- if the manufacturer or authorised representative has its registered office in another member state: you must provide proof of registration in EUDAMED or, where applicable, proof of notification to the competent authority before 28 May 2026.
• For class I devices covered by Directive 93/42/EEC and IVDs covered by Directive 98/79/EC that are subject to a transition period:
- if the manufacturer or authorised representative has its registered office in Belgium: no, you cannot obtain a free sale certificate if the device has not been notified to the FAMHP, where such notification was required prior to 28 May 2026 (in accordance with article 10 of the Royal Decree of 18 March 1999 and article 5 of the Royal Decree of 14 November 2001). No new notifications are possible since that date;
- if the manufacturer or authorised representative has its registered office in another member state: you must provide proof of notification to the competent authority.
• For devices placed on the market before 28 May 2026:
- the requirement to register in EUDAMED applies by 28 November 2026 at the latest. During this transition period, the FAMHP will accept either proof of notification number or proof that the device is registered in EUDAMED.
A declaration of conformity is drawn up by the manufacturer and must state the name of the medical device or the generic term, and confirm that the device complies with the essential requirements of the relevant directive (93/42/EEC for medical devices; 98/79/EC for in vitro diagnostic medical devices; 90/385/EEC for active implantable medical devices; Regulation 2017/745 for medical devices; Regulation 2017/746 for in vitro diagnostic medical devices). This declaration concerns one or more manufactured medical devices that can be clearly identified by their product name, product code or other unique identifier. For devices covered by Regulations (EU) 2017/745 and 2017/746, the basic UDI-DI must also be provided. The declaration is kept by the manufacturer. It must also be dated and signed by the manufacturer, with identification of the signatory.
A CE marking certificate is a certificate issued by a notified body certifying that the device complies with the requirements of Regulation (EU) 2017/745 (MDR) or (EU) 2017/746 (IVDR).
It is issued in the manufacturer’s name. The name and address of the manufacturer and the reference details of the notified body must be identical on both the CE certificate and the free sale certificate.
The CE certificate must cover the devices covered by the free sale certificate.
Certificates are billed on a 'fee-for-service' basis (payment per service). This rate is reviewed annually. Please refer to the PDF ‘Medical Devices’ on the Fees page, for more information on the current rates. The invoice is issued after the certificate has been issued.
Yes, the fee covers the time and effort spent on the dossier.
Yes. Legalisation is requested by the FAMHP via the eLegalisation online application provided by the Federal Public Service for Foreign Affairs, Foreign Trade and Development Cooperation. The document is uploaded to this platform. Once the document has been legalised, you will receive a payment request by e-mail. This payment relates solely to the legalisation of the document. The issuance of the free sale certificate is invoiced separately by the FAMHP.
Once payment has been made, the legalised document can be downloaded and includes a QR code that allows you to verify the authenticity of the signature online. This procedure is independent of the FAMHP. Please note: the document to be legalised may not exceed 10 MB. This is a technical limitation specific to the platform, and any file exceeding this size cannot be uploaded or processed.
This service is provided by the FAMHP, but the competent authority for legalisation remains the Federal Public Service for Foreign Affairs.
No. The FAMHP only performs legalisation of the signature on the certificates of free sale that it issues.
No.
Yes.
No, you will need to submit a new application.
No. It is the applicant’s responsibility to verify whether a free sale certificate is required.
A free sales certificate may include several medical devices as long as these devices belong to the same class and appear on the same CE certificate (when applicable). However, limits are set for each type of device:
- certificates for medical devices (MD) and active implantable medical devices (AIMD) may cover up to 10 different devices;
- certificates for in vitro diagnostic medical devices (IVDs) are limited to 40 devices.
A free sale certificate is delivered for one single importing country. If you wish to export medical devices to several countries, you must submit multiple applications.
A free sale certificate remains valid as long as the attached documents are valid and no information on the form is out of date.
No.
No. A producer of systems or procedure packs (System/Procedure Pack Producer, SPPP) is not considered to be a manufacturer of medical devices within the meaning of the Medical Devices Regulation (MDR), and a system or procedure pack does not, in principle, bear the CE marking.
Consequently, no free sale certificate (FSC) can be delivered for the system or kit as such.
The FSC must be applied for individually by the manufacturer (or their authorised representative) of each medical device forming part of the system or kit, in the member state where that manufacturer (or their authorised representative) has their registered office.