Medical Device Economic Operators in Ireland

The HPRA is requesting medical device economic operators based in Ireland, which includes all manufacturers, authorised representatives and distributors to enter their organisation details and related device information onto a new information system.  The information provided will be used for the purposes of market surveillance and for invoicing relating to medical device fees.

All queries relating to this system should be emailed to

Useful documents 

February 2018 - 

The European Commission have published a document entitled Withdrawal of the United Kingdom and EU rules in the field of industrial products which highlights the impact on economic operators.

Registration of Manufacturers of class I, class IIa and class IIb custom-made medical devices and Manufacturing Facilities under MDR/IVDR

Fields marked with an asterisk (*) are mandatory.

To move through the steps of the form please use the Next and Previous buttons that are at the bottom of the form.

  • Economic Operator
  • Contact Details
  • Organisation and Device Classification
  • Third Country Operator(s)
    (if needed)
  • Preview & Submit
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Economic Operator