The Registration Process

Submitting your registration request

As your UKRP, Umbilicus will submit your registration application to the MHRA with a ‘letter of designation’ verifying they are the UKRP.

There is a statutory charge by MHRA, currently £240 for each registration.

The registration process is relatively straightforward, with the following information requested:

    • Evidence that Umbilicus has been appointed as UK Responsible Person (UKRP)

    • Manufacturer legal name & address

    • Device name, model(s) and catalogue numbers

    • Regulation to which the device conforms, e.g., the EU Medical Devices Directive (MDD) 93/42/EEC, the EU Medical Devices Regulation 2017/745 or UK SI 618/2002 as amended

    • Proof of conformity assessment, e.g., CE marking Certificate and/or Declaration of Conformity, as applicable

    • Device classification

    • Is the device labelled as sterile, and if so, method of sterilisation

    • Is the device implantable? Active? single-use?

    • UK countries in which the device will be marketed (England, Scotland, Wales)

For UKCA marked devices, the following additional steps apply before starting the re-registration process:

    • If you have any Class I measuring/sterile, IIa, IIb, III/AIMD devices, inform your UK Notified Body 

    • Update your documentation to reflect Umbilicus as UKRP, e.g., Declaration of Conformity, technical documentation file, vigilance and post-market surveillance procedures

    • Update labelling to reflect the information provided by Umbilicus as your new UKRP.

 

After registration is approved

If your device currently has a CE mark, when the new UK registration is granted the MHRA will issue a confirmation letter and publish the manufacturer and device registration on its public database.

Typically, it takes 3-4 weeks to set up your authorised UKRP with MHRA and Umbilicus’ contact details must be printed on the UKCA marked label for each product by that time.

Registration costs for medical devices

The MHRA charges a fee of £240 for each registration. Companies can submit up to 100 device registrations for that single £240 fee, provided all device families are registered at the same time.

Once the registration has been granted, the manufacturer and the medical device(s) will be listed on the MHRA’s public registration database.

The registration fee does not include appointment of UKRP or verification of compliance of technical documentation by the UKRP.