Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

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

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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.

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