Certificate of Free Sale

The Certificate of Free Sale (CFS) is a document that certifies that a medical device marketed by a manufacturer (or their authorised representative) in Luxembourg complies with applicable legislation and can be marketed in the European Union (EU). The CFS is intended for a health authority in a non-EU importing country. It must be obtained by any manufacturer (or their authorised representative) that wishes to export a medical device (MD) or an in vitro diagnostic medical device (IVD) outside the EU.

CFS applications must be sent to the Health Directorate:

Division de la pharmacie et des médicaments
2a, rue Thomas Edison
L-1445 Strassen

using the forms below, in accordance with applicable legislation (see the 'More information' box). 

a) 'New devices', in accordance with the Medical Device Regulation (MDR) or the In Vitro Medical Device Regulation (IVDR):

Applications must be accompanied by the following documents:

  • An extract from the Luxembourg Trade and Companies Register (Registre de commerce et des sociétés - RCS), issued no more than 3 months prior to the application,
  • Declaration of conformity,
  • Valid certificate(s) of conformity, where applicable,
  • Quality Management System (QMS) certificate, if applicable,
  • Instructions for use,
  • Copy of labelling,
  • In some cases, Technical Documentation may also be required.

b) 'Legacy devices', in compliance with Article 120 of the MDR, or Article 110 of the IVDR (see also Regulation (EU) 2023/607) and the Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607:

Applications must be accompanied by the following documents:

c) 'Other devices' (Devices older than 'legacy devices'):

The issuing of a CFS for this type of product is currently the subject of a legal assessment. This page will be updated as soon as this assessment is completed.

The forms must be printed and signed by hand in N+1 copies, since the Health Directorate will keep a copy. Please note that a CFS application may only include the devices listed in the same Declaration of Conformity (DoC) and/or Certificate of Conformity (CoC).

The application must be accompanied by the documents listed below (copies of these documents may also be submitted by email to meddevices@ms.etat.lu).

For files larger than 10 MB, please send an email to meddevices@ms.etat.lu with 'Submission of a CFS application larger than 10 MB' in the Subject line. You will then receive an email containing an OTX (One-Time Exchange) link that you can use to send your files.

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