My HPRA: Register

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 devices@hpra.ie

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 National Economic Operators/Organisation

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
Details of Device Types
T&C and Payment
Preview & Submit

Economic Operator

Name of Economic Operator/Organisation*

Please indicate your organisation type * Custom-made manufacturer (class I, class IIa and class IIb devices only)
Distributor
Health Institution
Manufacturing facility/site

Address 1 *

Address 2

Address 3

City*

County *

Eircode *

Organization Size*

Turnover *

Companies Registrations Office (CRO) Number*

VAT number *

EORI number

Are you registering under MDR?* YesNo

Are you registering under IVDR?* YesNo

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