The Competent Authorities for Medical Devices (CAMD) network issued on June 2022 a document on Questions and Answers regarding Free Sales Certificates (FSC) and Article 60 of the Medical Devices Regulation 2017/745. With the aim to provide further guidance to member states and economic operators, the Q&A document also outlines specific cases in which national provisions are needed. Therefore, among others, it addresses the following questions:
- To whom can a Member State issue a Certificate of Free Sale under Article 60 of the Regulation?
Certificate of Free Sale issued under Article 60 of the Regulation can be issued by the member state to manufacturers or authorised representatives that have their registered place of business in their jurisdiction. The ‘manufacturer’ is defined as a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark. Therefore, a manufacturing site that is not the manufacturer as defined may not be eligible to request a Certificate of Free Sale.
- Can Member States issue a Certificate of Free Sale under Article 60 of the Regulation to distributors and importers?
No, Certificate of Free Sale issued under article 60 of the Regulation can only be issued by the Member State to manufacturers or authorised representatives that have their registered place of business in their jurisdiction. It is understood that for some third country distributors and importers may be required to provide supporting documentation. In such instances, it is recommended that a Certificate of free sale be obtained from the member state where the manufacturers or authorised
representatives have their registered place of business and that additional documentation for the purpose of export is obtained from the member states where the distributor or importer is located. The additional documentation (e.g.: a statement, a letter, or another type of certificate etc.) would have to be issued under national provisions with no reference to article 60 of the MDR, but it can make a reference that the devices bear the CE mark according to the medical devices legislation.
- Should an expiry date be included on a Certificate of Free Sale, and if so how should the expiry date be calculated?
The regulation does not prescribe a specific expiry time for a certificate of free sale. The expiry date assigned will depend on the processes that have been adopted by the national competent authority to whom the request for the certificate of free sale has been made. Where possible competent authorities should ensure that where an expiry date is assigned that it is aligned with the EU declaration of conformity and the notified body certificates for the devices detailed in the certificate of free sale. The issuing competent authority assesses the conformity of the devices at the time when the certificate is requested, this ensures that the certificate is valid on the date of issue.
- Should Certificate of Free Sale for legacy devices be issued under the MDR or the Directives?
Certificate of Free Sale for legacy devices (devices that were certified under the Directives and continue to be placed on the market under Article 120 (3)) can only be issued under the Directives.
- Can a Certificate of Free Sale still be obtained for devices that are compliant with the Directives and for how long will it be possible to obtain such Certificate of Free Sale?
Certificate of Free Sale can continue to be issued, under national provisions for devices that are compliant with the Directives in the following situations:
1. For devices that are compliant with the medical device directives (MD & AIMD) and were placed on the market before the date of application – until they exit the supply chain. (in accordance with Article 120(4) MDR).
2. For devices that will be up classified under the MDR (in accordance with Article 120(3) MDR).
3. For device that were certified under the directive and continue to be placed on the market under Article 120 (3) of Regulation (EU) 2017/745.
Under Article 120 self- declared and Notified Body certified devices can remain in the supply chain until May 2025. However it must be noted that notify body certificates associated with the Article 120 (3) devices may only be valid until May 2024. As the Certificates of free sale relating to such devices should be issues under national provisions the issuing competent authority will assess the conformity of the devices at the time when the certificate is requested and determine if a Certificate of Free Sale can be provided. This assessment will depend on the processes that have been adopted by the competent authority.
Do you wish to know more about FSC requirements? You can find these and other relevant guidances for your devices in our MDlaw Library.
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