Decommissioning of the Extranet online registration system

We have decommissioned our Extranet online registration system. This affects the following stakeholders currently registered under the MDD, AIMDD or IVDD:

• Manufacturers,
• Manufacturing facilities,
• Custom made medical device manufacturers, 
• Authorised representatives.

Registrations previously completed through our Extranet system will remain valid in the context of the MDD, IVDD and AIMDD.

Why was the Extranet registration system decommissioned?

We have decommissioned our Extranet registration system due to the application of:

• The Medical Devices Regulation (MDR), and
• The In Vitro Diagnostic Medical Devices Regulation (IVDR).  

We built our Extranet registration system to facilitate registrations under the Directives and it has since reached its end of service life. All economic operators and devices should be registered under the MDR and IVDR accordingly.

For more information on how to meet your registration requirements under the MDR and IVDR, please review our HPRA registration page. The webpage outlines specific requirements and step by step instructions for each type of economic operator on how to register.

How has this affected stakeholders?

Stakeholders no longer:

• Have access to the Extranet system. 
• Have access to proactively update or withdraw your economic operator details or device information under the Directives.
• Are able to amend or withdraw device information or pull device reports from the Extranet system for Directive compliant devices.

Will the HPRA accept changes to registration information?

We will only accept changes to information relating to:

• The registered address of an organisation.

• The description of the device used to identify it.

Should you need to change this information, please email us at deviceregister@hpra.ie and clearly outline your required changes.

You do not need to notify us of changes to other information for Directive compliant devices previously registered via the Extranet such as changes to GMDN codes. 

Should you need any device reports please contact us directly at deviceregister@hpra.ie.