Europe-CE Marking MDR / IVDR

Free Sales Certificate (FSC) for Medical Devices & IVDs

Free Sales Certificate (FSC) for Medical Devices & IVDs

A Free Sales Certificate (FSC) is an essential document for medical device and in vitro diagnostic (IVD) manufacturers seeking to export their products outside the European Union (EU). At Alpine Quality Consultants, we assist manufacturers in obtaining FSCs from the relevant EU Competent Authorities, ensuring smooth international trade and regulatory compliance.

What is a Free Sales Certificate (FSC)?

A Free Sales Certificate (FSC) is an official document issued by an EU Competent Authority confirming that:

  • The medical device or IVD is CE-marked and compliant with MDR (2017/745) or IVDR (2017/746)
  • The product is legally marketed within the EU/EEA
  • The manufacturer has met all regulatory and safety requirements

Many non-EU countries require an FSC as part of the registration process before allowing medical devices into their markets.

Who Can Apply for an FSC?

Contract Manufacturers & Suppliers

EU Manufacturers

Can apply directly to their national Competent Authority

Medical Device & IVD Manufacturers

Non-EU Manufacturers

Must apply through their EU Authorised Representative (E.A.R.)

Distributors & Importers

Importers & Distributors

May need FSCs for regulatory approval in target countries

Our Free Sales Certificate Services

FSC Application Support

  • We assist in preparing and submitting applications to the relevant EU Competent Authorities

Document Preparation & Review

  • Ensuring your CE Marking, Declaration of Conformity (DoC), and Technical File meet requirements

Coordination with Competent Authorities

  • Managing the communication with health authorities for a smooth approval process

FSC Renewal & Updates

  • Assisting with renewals or modifications based on regulatory changes
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