Verification of economic operator registration details for medical device inspections

We are conducting an activity to verify the registration details of medical device economic operators prior to conducting inspections.

Those selected for this activity will receive an email from the HPRA directing them to complete a Microsoft Office Form.

The details requested in the form include, for example:

• contact details,
• the address of the registered business,
• the roles undertaken by the EO,
• the location(s) of any other associated businesses or outsourced activities.
  

Please complete the form in response to these requests in a timely manner and provide all relevant information.

Updates to registration details

Economic operators are reminded that registration details, on both the HPRA’s national registration database and on Eudamed, should be kept up to date. 

To update a national registration

• Contact us using our contact form and request your current registration details and to provide any relevant updates. On the form please select Medical devices > Registration query. 

To update a Eudamed registration:

• Consult the Eudamed user guideOpens in new window.