Certificates of free sale

This page is for device industry.

It provides information about certificates of free sale for medical devices.  It describes what they are and how to apply for one.

What is a certificate of free sale?

A certificate of free sale is a document used in the registration of a device in a third country (i.e. countries outside the EU). It indicates that a device is compliant with EU law.

How do I get a certificate of free sale?

If you are a manufacturer or authorised representative based in Ireland and would like to obtain a certificate of free sale, you must submit our certificate of free sale online form, a device schedule and associated documents (listed in form). Please submit any queries via our online contact form.

A certificate of free sale checklist is included in the application form to help you prepare your application.