Email: cs@nedystec.com

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Free Sales Certificate

Free Sales Certificate

A Certificate of Free Sale (CFS) is a crucial document for manufacturers and authorised representatives exporting medical devices outside the EU. Issued under Article 60 of Regulation (EU) 2017/745 (MDR), it confirms that the device complies with EU regulatory requirements, bears the CE marking, and may be lawfully marketed within the EU.

Why You Need?

Why You Need?

A CFS simplifies the export of medical devices to countries requiring evidence of EU regulatory compliance and marketability.


It provides foreign authorities with formal confirmation that the device meets all applicable EU safety and performance requirements.


This document supports and accelerates product registration and market entry in multiple non-EU jurisdictions.


What NEDYS Do?

What NEDYS Do?

  • Assist you in preparing FSC certification application documents


  • Guide compliance with EU FSC forest management standards


  • Liaise with certification bodies to advance audit processes


  • Provide certification compliance consulting and post-certification maintenance support

Why Choose NEDYS?

Why Choose NEDYS?

  • Expert Guidance on EU Standards: We provide professional guidance to ensure your full compliance with EU FSC standards and regulatory requirements.


  • Direct Liaison with Certification Bodies: We offer dedicated coordination with certification bodies to help speed up your audits and approval processes.


  • Time and Cost Efficient: We use streamlined procedures to reduce your preparation time, avoid delays, and lower your overall certification costs.


  • Proven Track Record: We have successfully assisted 30+ clients in obtaining official Free Sale Certificates with high approval rates.

Online Consultation

+31 626615194

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