UK Medical Device and In Vitro Diagnostic Device Registration

Manufacturers must register their devices with the Medicines and Healthcare products Regulatory Agency (MHRA) before placing them onto the Great Britain* market. Devices must be CE marked or UKCA marked before they can be registered.

Where the manufacturer is not located in the UK, their appointed UK Responsible Person (UKRP) must register devices on the manufacturer’s behalf. 

Learn more about how Casus can help with: UK Responsible Person (UKRP)

Registration Steps, Time and Cost

The registration is more of a notification process. The registration is not intended to validate device safety or efficacy. In fact, the MHRA’s registration confirmation letter and registration guidance both explicitly state that the registration does not constitute an approval or certification of the device.

The registration process is relatively straight-forward, with the following (non-exhaustive list) information requested:

    • Proof of UKRP appointment, e.g., Letter of Designation or Agreement (non-UK manufacturers only)
    • Manufacturer legal name & address
    • Regulation to which the device conforms, for example, the Medical Devices Directive 93/42/EEC
    • GMDN code
    • Device classification
    • Whether it’s labeled as sterile, and if so, method of sterilization
    • Whether the device is implantable; active; single-use; etc.
    • Copy of the applicable verification of conformity assessment, for example, a CE marking Certificate or Declaration of Conformity, as applicable
    • Device name, model(s) and catalogue numbers
    • In which UK countries the device will be placed

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

The MHRA quotes a six-business day timeframe to review applications. However, the review time may be extended if the MHRA has a backlog of registrations to process.

The MHRA can request to review more information about the device during their review. For example, the assessor could ask to receive more information about the classification rationale, request a copy of the instructions for use or images of the device. This would extend the review 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 must be renewed one year after being granted. Thereafter, renewals are required every two years.

The MHRA gave manufacturers the below grace periods to register.

As these timeframes have now expired, manufacturers must register with the MHRA before placing any medical devices onto Great Britain.

Previous Transition Deadlines

    • 1 May 2021 – AIMD / Class III / Class IIb implantable / IVD List A
    • 1 September 2021 – Class IIb non-implantable / Class IIa / IVD List B / IVD self-test
    • 1 January 2022 – Class I / General IVDs / custom-made devices

Important Note About the UK Countries

The UK is made up of four countries and all four countries have left the European Union.

England, Scotland and Wales make up Great Britain. Great Britain requires appointment of a UKRP and registration of devices with the MHRA. Further, they will eventually require devices be UKCA marked in order to be placed onto the Great Britain market. There is currently a transition period, to temporarily accept CE marked devices. The transition period dates are outlined: HERE

The fourth UK country is Northern Ireland. Northern Ireland requires, and will continue to require, CE marking to lawfully place devices onto its market. The MDR/IVDR registration requirements must be met for Northern Ireland. And where a manufacturer is not located in the EU/EEA, they are required to appoint an Authorised Representative prior to placing devices onto the Northern Ireland market. However, a UKRP and device registration with the MHRA may still be required for Northern Ireland in some situations.

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