Why You Need a Free Sales Certificate
Legal background
A Free Sales Certificate is an official document issued by an EU competent authority that confirms your device is CE-marked and authorized for sale in the EU market. As the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) are among the most rigorous globally, many non-EU countries recognize EU compliance as a benchmark for safety and quality.
Having an FSC certification:
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- Facilitates smoother, faster entry into non-EU markets.
- Demonstrates your product is lawfully marketed in the EU.
- Serves as mandatory documentation in international registration dossiers.
- Avoids delays and increases your product’s global competitiveness.
- Reinforces the credibility and reliability of your brand.
Our services
Accelerate Global Market Access with an FSC
Obelis handles the entire FSC certification process on your behalf, whether you’re an EU-based manufacturer or a non-EU company working through an Authorised Representative. We compile and validate all the necessary information, including:
- Basic UDI-DI (for MDR/IVDR devices)
- CE Certificates and Declaration of Conformity
- Notification numbers for Class I, Is, Im, Ir & IVD devices
- Manufacturer and Authorised Representative details
- ISO 13485 or ISO 9001 certification (if applicable)
- Answers to regulatory substance-related questions
We ensure your request complies with the latest Belgian Competent Authority requirements, including the updated FSC format (now also applicable to legacy devices). With Obelis, your application is submitted swiftly and accurately, removing regulatory obstacles from your path to global sales. Learn more about our complete range of healthcare services designed to support product safety, compliance, and global access.
FAQ
Frequently Asked Questions
Typical documents include your CE Certificate, Declaration of Conformity, , UDI-DI (if applicable), manufacturer and authorised representative details, and any additional country-specific documentation requested by the Competent Authority.
Yes, legacy devices can apply for an FSC provided they comply with the relevant EU Medical Devices Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR) requirements and the latest Competent Authority guidelines.
Both EU-based manufacturers and non-EU manufacturers (through an appointed EU Authorised Representative) are eligible to apply for an FSC confirming legal sale within the EU market.
Obelis acting as your authorised representative or simply your regulatory consultant, managing the entire FSC application from document compilation and validation to submission. We ensure compliance with all current regulatory requirements, liaise with Competent Authorities, and expedite your certificate issuance for smoother global market access.
