- Registration Steps, Time, and Cost
- Why should you choose Casus?
- Important note about the UK countries
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
- 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?
The MHRA charges a fee of £240 for each registration. Companies can submit up to 100 device applications under that £240 fee, if all device families are registered at the same time.
What is the registration review 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.
If the device is straight-forward and there is no backlog, then the application may be processed in as little as 1-2 business days.
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.
Whether you need a quote or just want to discuss the best options for your business, we will help guide you.
What is the UK registration deadline?
The ‘Brexit’ transition period has expired. As of 1 January 2022, all manufacturers must have registered their medical devices and IVDs 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?
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
From a regulatory standpoint, the UK is made up of two territories:
- Great Britain (England, Scotland, Wales) is subject to the UK MDR 2002 requirements. This means devices may be either UKCA or CE Marked; and non-UK companies must appoint a UKRP.
- Northern Ireland, the fourth UK country, does not and will not recognize UKCA Marking. Due to Brexit negotiations, Northern Ireland will continue to be part of the European Single Market and require CE Marking.