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 (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 26th May 2020. 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 . 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: