Manufacturers must register their medical devices and IVDs with the Medicines and Healthcare products Regulatory Agency (MHRA) before placing them onto the Great Britain market.
Where the manufacturer is not located in the UK, their appointed UK Responsible Person (UKRP) must register devices on the manufacturer’s behalf.
Read below for the full details.
Registration Steps, Time, and Cost
What information is required for the registration application?
The registration is more of a notification process. The registration is not intended to validate the medical device’s 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. Therefore, devices must be CE Marked or UKCA Marked before they can be registered. Proof of CE or UKCA Marking must be provided in the MHRA registration application.
The registration process is otherwise relatively straight-forward, with the following (non-exhaustive list) information requested:
- Proof that a UK Responsible Person (UKRP) has been appointed (non-UK manufacturers only)
- Manufacturer legal name & address
- Type of device: general medical device, IVD, active implantable, system/procedure pack
- Regulation to which the device conforms, e.g., the EU Medical Devices Directive (MDD) 93/42/EEC; UK MDR 2002; IVDR 2017/746; etc.
- GMDN code
- Classification
- Whether it’s labeled as sterile, and if so, method of sterilization
- Whether the device is implantable; active; single-use; etc.
- If it is custom-made or not
- Proof of conformity assessment, e.g., 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
- Great Britain (England, Scotland, Wales) accepts UKCA Marking or CE Marking
- Northern Ireland, the 4th UK country, only accepts CE Marking
What is the registration application fee?
As of April 1, 2026, there is no upfront registration fee; instead, the MHRA charges an annual fee of £300 per GMDN Level 2 category (this is the broad device type classification assigned to your product). If you submit a registration mid-fiscal year, then a prorated annual fee will apply.
What is the registration review time?
The MHRA’s official review time is 5 business days. However, most devices are typically approved within 1-2 business days.
The MHRA can request to review more information about any 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 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. The MHRA currently does not charge a renewal fee.
Further, if there are any changes to the information originally supplied in the registration (e.g., device characteristics, manufacturer address, etc.), this must be updated in the registration. Fees may apply, depending on the type of change.
Need Help?
Reach out to explore how we can assist with your market entry or provide a tailored quote. We would be happy to schedule a no-obligation call to discuss your needs.
What is the UK registration deadline?
As of 1 January 2022, all manufacturers must register their medical devices and IVDs with the MHRA in order to place them onto the market.
Non-UK manufacturers must further appoint a UK Responsible Person (UKRP), who will then complete their registrations. UK-based manufacturers may register medical devices and IVDs on their own.
Why should you choose Casus?
Fast, Responsive Service: Our client onboarding is one of the fastest in the industry, completed in days compared to the weeks (or months) quoted by other providers. High-quality project management means you can be confident about results and timelines.
Transparent, Fair Pricing: No hidden costs or surprise fees. We don’t increase your UKRP service fee when you add products later. You’ll receive straightforward, professional service with clear pricing from the start.
Experienced Regulatory Team: We have completed hundreds of UK device registrations and understand how to navigate MHRA requirements efficiently. You will have direct access to knowledgeable regulatory professionals; no intermediaries, junior employees, or ticket systems.
Proven Track Record: Trusted by 250+ medical device and IVD manufacturers across 20 countries for EU, UK, and Swiss regulatory representation services.
Important note about the UK countries
From a regulatory standpoint, the UK is made up of two territories:
- Great Britain (England, Scotland, Wales): Requires a UK Responsible Person (UKRP). Currently accepts CE or UKCA Marking; transitioning to UKCA Marking only by 2028-2030.
- Northern Ireland: Follows European regulations, requiring an EU Authorized Representative (if manufacturer is located outside of Europe/Northern Ireland) and CE Marking. Does not recognize UKCA marking or UKRPs.
