What is a CFS?
A Certificate of Free Sales (also known as a Free Sales Certificate or CFS) is a document which proves that a medical device is registered in the European Union. It contains information about you (the manufacturer), the EC Rep (Authorised Representative for medical devices), and the concerned medical device. A CFS can only be used for export outside the European Union.
Why do I need a CFS?
A CFS is often requested by companies based outside of the European Union. For them, the CFS is proof that your device meets the European CE marking requirements.
Can I request a CFS myself?
If you are a manufacturer based in the European Union, you can apply for a CFS yourself at the ministry of the country where your company is based. If you are established outside of the EU, you can hire an authorised representative to apply for a CFS on your behalf.
How can we help?
If your company is based outside of the EU, we can request a CFS as your EC Rep (EU Authorised Representative for Medical Devices). Here’s a step-by-step overview of how we would help you obtain your Certificate of Free Sales:
- Draw up an EC Rep Mandate (Authorised Representative agreement)
- Carry out a Technical Documentation review
- Registration of the medical device with the competent authority (when the medical device is a class I device)
- Apply for the Certificate of Free Sales with the competent authority
- When required, ensure the Certificate of Free Sales is legalized or is provided with apostille
Find More Insights
Construction Products Regulation 2013
The lifts and safety components of lifts Directive 2014/33/EU
CETA, Trade agreement between the EU and Canada
Personal Protective Equipment (PPE) Regulation EU 2016/425
Full-service product compliance
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