My HPRA: Register

Medical Devices Extranet Registration Form

Registration Process for medical devices and IVDs in accordance with the Directive (93/42/EEC, 98/79/EEC)

Please complete all steps and review.

You will be prompted to print the Terms & Conditions, please ensure you have a printer connected.
Sign the Terms & Conditions and send to deviceregister@hpra.ie (electronic submissions only).
For further information on registering with the HPRA, please refer to Regulatory Information: Registration.

Note: The new EU medical device Regulations entered into force in May 2017. The medical devices Regulation has a three year transition period and is fully applicable from 26 May 2021. The in-vitro diagnostic medical device Regulation has a five year transition period and is fully applicable from 26 May 2022.

If you intend on registering medical devices compliant with the new Regulations during the transition period please contact devices@hpra.ie. Guidance on registration under the new Regulations will be provided in due course.

Register for the Medical Devices Extranet

To request access to the Medical Devices Extranet please register below:

Organisation

Please indicate if your organisation is registering under the Directive 93/42/EEC concerning Medical Devices or Directive 98/79/EC on in-vitro Diagnostic Medical Devices: *Medical Devicein-vitro Diagnostic Medical Devices

Please indicate your organisation type by selecting from the drop down menu: *

Organisation Size: *

Please indicate the status of your organisation: *

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