CFS for Medical Devices: All You Need to Know

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