All medical devices, including IVDs intended to be sold in the GB market should be registered in Medicines and Healthcare products Regulatory Agency (MHRA).
Device registration in MHRA can proceed by using the Device Online Registration System (DORS).
The Device registrations Reference Guide issued by MHRA provides details on how to set an account in DORS as well as the required information for device registration.
IMPORTANT:
The UKRP (or Northern Ireland Authorised Representative) name and address should also be registered in DORS for manufacturers outside UK.
We are here to assist​
Need more details?
Phone Number
+44 7817 360710
Email Address
info@evnia-ar.com
Website
https://www.evnia-ukrp.co.uk
Address
167-169 Great Portland Street, 5th Floor, London, W1W 5PF.
