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The Competent Authorities
for Medical Devices (CAMD) have issued a new guidance document: Questions & Answers on Certificates of Free Sale
Certificates of Free Sale (CFS), also referred to as Export Certificates and Free Sale Certificates, are often requested by manufacturers to support international medical device registrations, such as in the Kingdom of Saudi Arabia and the Philippines.
While the old Directives
do not address Certificates of Free Sale, the new MDR/IVDR do explicitly reference them under Articles 60 (MDR) and 55 (IVDR).
The new CAMD document provides practical guidance on Article 60 of the MDR.
- A CFS will only be issued to a European manufacturer or the EU authorized representative. A CFS will not be issued to an importer, distributor, nor to a non-EU manufacturer.
- A CFS will not be issued to System and Procedure Pack Producers (SPPP). This is because a system/procedure pack is not a device as outlined by Article 1(4) of the MDR and is typically not CE marked; therefore the SPPP is not a manufacturer of a device.
- Items required for a CFS request include:
- An application form
- Copies of the EU Declaration of Conformity
- Copy of the CE Certificate, if applicable
- Details of the manufacturer, and where applicable the authorized representative, and device registrations
- The Basic UDI-DI
- Copy of the label and Instructions for Use (IFU)
- Copy of the ISO 13485 certificate, if applicable
- What will be included in the CFS? Non-exhaustive list below:
- Name and address of the manufacturer
- Name and address of the authorized representative, where appropriate
- Name and address of the manufacturing site, where appropriate
- Details of the Basic UDI-DI
- Details of the EU Declaration of Conformity, such as the legal framework (MDD/MDR) and date of issue
- Details of the EC Certificate, such as Notified Body identification, Certificate Number, legal framework (MDD/MDR), date of issue and validity (where appropriate)
- Signature or Stamp from the issuing Competent Authority
- Will the CFS expire?
- The MDR doesn’t specify an expiration timeframe for a CFS. Therefore, it will depend on the process adopted by the individual national competent authority. NOTE: the Irish Competent Authority, where Casus is located, does not include an expiration date on the CFS.
- Can a single CFS cover both self-certified and Notified Body CE marked devices?
- It is possible to include both. However, it is up to the national competent authority to choose if they will do so.
- Can a CFS include both MDD and MDR CE marked devices?
- A CFS issued under Article 60 may only be issued for MDR CE marked devices. Therefore, separate certificates must be issued for MDD and MDR CE marked products.
- Can a CFS be issued for ‘legacy’
- Yes, if the device is compliant under the Article 120(3) transition provision. The national Competent Authority will review the device details during the application request to confirm if it is appropriate to issue a CFS for the device.
- Can a Competent Authority issue a CFS under an electronic signature instead of a ‘wet’ signature?
- There is nothing that prohibits the Competent Authorities from doing so; however, the CAMD as a group does recognize that some countries will not accept electronic signatures.