How to register your medical devices and IVDs in the UK
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.
Registration Steps, Time and Cost
What information is required in a UK medical device registration?
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
What is the cost and time to register medical devices in the UK?
The MHRA charges a fee of £240 for each registration. Companies can submit up to 100 device registrations under that £240 fee, if all are registered at the same time.
The MHRA quotes a five-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.
What happens after the UK medical device registration is complete?
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.
By when is medical device registration needed in the UK?
The MHRA transition period has expired. As of 1 January 2022, all manufacturers must have registered their devices in order to place them onto the market.
Non-UK manufacturers must appoint a UK Responsible Person (UKRP), who will then complete their registrations. UK-based manufacturers may register devices on their own.
Why should you choose Casus?
Our team has completed hundreds of UK MHRA registrations, so we know how to get you to market quickly and efficiently.
Our client onboarding is one of the fastest on the market – days compared to the weeks and months quoted by other providers. And our high-quality project management means you can be confident about the results.
We are transparent and fair – no hidden costs that you learn about too late, and no increased UKRP service fee if you add products later. Instead, you can expect straightforward, professional service from our knowledgeable team.
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. 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.