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 can submit an application form to us by email at devices@hpra.ie.
We have a Guide to Applications for Certificates of Free Sale for Medical Devices. This guide describes how to select, complete and submit an application form to us.
We also have a certificate of free sale checklist which may help you to prepare your application.
You can find a list of application forms below.
What application form should I use?
MDR compliant devices
For MDR compliant devices, please use our MDR certificate of free sale application form.
IVDR compliant devices
For IVDR compliant devices, please use our IVDR certificate of free sale application form.
MDD or AIMDD devices qualifying under Regulation 2023/607
If your devices qualify under Regulation 2023/607, please use our Application for Certificates for free sale for devices qualifying under Regulation 2023-607.
For more information about Regulation 2023/607, please see our MDR transitional provisions webpage.
MDD or AIMDD devices not qualifying under Regulation 2023/607
If your devices do not qualify under Regulation 2023/607, please use our general MDD/AIMDD certificate of free sale application form.
IVDD compliant devices
For IVDD compliant devices, please use our IVDD certificate of free sale application form.