EU Free Sale Certificate

📜 What is a Certificate of Free Sale?

• A Certificate of Free Sale (CFS) is an official document issued under Article 60 of the EU Medical Device Regulation (MDR 2017/745).

• It confirms that a medical device:

• Bears the CE marking

• Meets EU regulatory standards

• Is legally placed on the EU market

🌍 Why is it Needed?

• Export Requirement: Many non‑EU countries require proof that a product is freely sold in its country of origin before granting import or registration approval.

• Regulatory Assurance: It reassures foreign authorities that the device complies with EU safety and performance standards.

• Market Access: Without a CFS, manufacturers may face delays or rejection when trying to register or sell devices abroad.

• Trade Facilitation: It streamlines customs clearance and regulatory submissions in countries outside the EU.

🏢 Who Can Request It?

• Only EU manufacturers or their authorised representatives with a registered place of business in an EU Member State can apply for a CFS.

• Importers, distributors, or non‑EU manufacturers cannot directly request it.

📑 What Does It Contain?

A typical CFS includes:

• Manufacturer’s name and address

• Authorised representative’s details (if applicable)

• Device information (including Basic UDI-DI)

• CE marking confirmation

• Declaration of Conformity and notified body certificates (if relevant)

EUCEREP B.V. can help you and request a free sale certificate on behalf of the non-EU manufacturers

Contact us for a quote and timeline eucerep@eucerep.com or WhatsApp +31685008887

For more details https://english.farmatec.nl/medical-devices/free-sales-certificates-for-medical-devices