Module 19 2021

01/06/2021

Device Registration Portal

IVDs and the legal manufacturers must be registered before placement on market Non-UK Manufacturers must appoint a UKRP to register on their behalf Portal has undergone a period of updates, but generally user friendly Guidance documents and videos are available to support the process

01/06/2021

IVDeology Ltd | www.ivdeology.co.uk

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Applications

UK based Manufacturers register their establishment via the portal Applicable to all classes of IVDs and devices for performance evaluation Application is verified by the MHRA and accepted within the portal, no formal documentation is needed for this process. UK Responsible Persons register non-UK manufacturers in their behalf Non-UK Manufacturers need a UK address and phone number to complete application UKRP will require a letter of derogation from the Manufacturer including an Annex of the devices intended to be registered. Importers and distributors are not required to register within the database, however a list of the importers shall be retained by the UKRP and provided to MHRA Juvenile system so MHRA and users are still finding their feet, good level of communication between users and MHRA.

01/06/2021

IVDeology Ltd | www.ivdeology.co.uk

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