Certificates of free sale for medical devices

This webpage provides you with information about certificates of free sale for medical devices. It describes what they are and how to apply for and obtain 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 and manufacturers may sell it on the EU market.

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 can submit an application form to us by email at devices@hpra.ie.

We have developed a Guide to Applications for Certificates of Free Sale for Medical Devices. This guide provides you with detailed instructions on how to select, complete and submit an application form to us.

We have also developed a certificate of free sale checklist which may help you to prepare your application.

You can find a list of application forms below.

Application forms

Applications for MDR-compliant devices

Applications for IVDR-compliant devices

Applications for medical devices compliant with the MDD or AIMDD

Applications for IVDs compliant with the IVDD