Understanding the Certificate of Free Sale in the EU: A Comprehensive Guide
What is a Certificate of Free Sale?
A Certificate of Free Sale (CFS) is an essential document for manufacturers and authorised representatives looking to export medical devices outside the European Union (EU). Issued under Article 60 of the Regulation (EU) 2017/745 on Medical Devices (MDR), this certificate verifies that a medical device meets the EU's regulatory standards and bears the CE marking, demonstrating that the device can be legally marketed within the EU.
Importance of the Certificate of Free Sale
The CFS is crucial for several reasons:
- Facilitation of Trade: It streamlines the process of exporting medical devices to countries that require proof of regulatory compliance and marketability within the EU.
- Regulatory Assurance: It provides assurance to foreign regulatory bodies that the device meets EU safety and performance standards.
- Market Access: An EU issued CFS can facilitate and streamline registration and market access in a range of non-EU countries.
Eligibility for a Certificate of Free Sale
Only manufacturers and authorised representatives with a registered place of business within an EU Member State can request a CFS. This includes:
- Manufacturers: Defined as any natural or legal person who manufactures or fully refurbishes a device or has it designed, manufactured, or fully refurbished, and markets it under their name or trademark.
- Authorised Representatives: Any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer outside the Union to act on their behalf concerning specific regulatory obligations.
Notably, distributors, importers and non-EU manufacturers are not eligible to request a CFS.
Requirements and Documentation for a Certificate of Free Sale
The specific documentation required can vary by Member State, but generally includes:
- Application Form: Completed and signed application form provided by the competent authority.
- EU Declaration of Conformity: Copies of declarations for each device listed on the CFS.
- EC Certificates: Copies of the certificates issued by a notified body for the devices.
- Manufacturer and Authorised Representative Details: Including registrations and contact information.
- Basic UDI-DI Details: Unique Device Identification information for traceability.
- Label and Instructions for Use (IFU): Copies of labelling and IFU for each device.
- ISO Certifications: Relevant ISO certifications, if applicable.
As EUDAMED, the European database on medical devices, becomes fully functional, the documentation requirements may be streamlined, as much of this information will be available electronically.
Contents of a Certificate of Free Sale
A typical CFS includes:
- Name and address of the manufacturer.
- Name and address of the authorised representative (if applicable).
- Name and address of the manufacturing site (if applicable).
- Basic UDI-DI details.
- Details of the EU Declaration of Conformity, including the legal framework and date of issue.
- Details of the EC Certificate, such as the Notified Body identification, Certificate Number, legal framework, date of issue, and validity.
- Signature or stamp from the issuing competent authority.
Expiry and Validity
The MDR does not specify an expiry date for a CFS. The expiry date is determined by the national competent authority issuing the certificate and is typically aligned with the EU Declaration of Conformity and the certificates issued by the notified body.
Importance of the EU Authorised Representative
An EU Authorised Representative (EUAR) plays a vital role for non-EU manufacturers. The EUAR ensures that the manufacturer complies with EU regulations and can act on behalf of the manufacturer concerning specific regulatory obligations. This role is essential because a CFS cannot be issued to a non-EU based manufacturer.
Acceptance of the Certificate of Free Sale
Regulatory authorities around the world widely accept a CFS issued in accordance with Article 60 of the MDR. It assures that the medical device meets EU regulatory requirements, facilitating international trade and market entry.
In conclusion, the Certificate of Free Sale is a critical document for exporting medical devices from the EU, ensuring compliance with regulatory standards and facilitating global trade. Manufacturers and authorised representatives must ensure they meet all necessary requirements and maintain up-to-date documentation to obtain and renew their CFS.
At Med-Di-Dia, we have successfully assisted our clients in obtaining Certificates of Free Sale. As an experienced RAQA Consultancy and EU Authorised Representative, we facilitate this request for both EU-based and international manufacturers. To request our services, email us at mdd@mddltd.com or fill out our web form https://med-di-dia.com/contact.php.
We are your Regulatory Risk Partner for Medical Devices, Diagnostics, and Digital Health!
More information
https://www.camd-europe.eu/wp-content/uploads/2022/06/140622_CoFS_QnA_CAMDEndorsed.pdf
