Page Last Updated: 28 April 2023
In Short
Yes, possibly for certain low-risk devices. Please read below for more details.
Page Last Updated: 28 April 2023
Yes, possibly for certain low-risk devices. Please read below for more details.
When the UK left the European Union (EU), the EU MDR/IVDR had not yet been implemented into its legislation. Therefore, at the time of its withdrawal from the EU, the prevailing regulations were based on the old European medical device, active implantable and IVD Directives (MDD/AIMDD/IVDD).
The MHRA announced at the time of withdrawal that they would implement their own medical device authorization system, called UKCA Marking. Further, that they would “upgrade” their current MDD/AIMDD/IVDD-based legislation and introduce more robust legislation.
In the meantime, to avoid a disruption in supply, the UK government put a transition period into place. As part of the transition period, the MHRA will allow CE Marked devices onto the UK market. The deadline to UKCA Mark devices was set for 1 July 2023. However, the MHRA recently announced that the new UKCA regulation will be postponed to July 2025. Further, that it would implement a longer transition period to accept CE Marking.
Information about the new UKA Marking deadline and CE Marking transition period can be found: HERE
NOTE: The UK is made up of four countries: England, Scotland, Wales (“Great Britain”) and Northern Ireland. All four countries have left the EU. Great Britain is expected to require UKCA Marking in the future. However, Northern Ireland currently requires, and will continue to require, European CE Marking. This was arranged under the ‘Brexit’ agreement in order to ensure the movement of goods and people between Northern Ireland (UK country) and Ireland (EU country).
In order to market devices in the Great Britain, manufacturers must:
For more information on the requirements, please read: UK Medical Device Registration
CE Marking will be allowed until:
Currently there are only four UK Approved Bodies designated to issue UKCA Marking certificates. The list of UK Approved Bodies is available: HERE
Unless a further extension is granted, UKCA Marking will be mandatory for all medical devices and IVDs in Great Britain by 30 June 2030.
For most companies, it is logical to continue marketing with their EU CE marking. The reasons include:
However, there is an instance in which it may be beneficial to UKCA mark early. This is related to device classification.
The current UKCA marking legislation is based on the MDD/AIMDD/IVDD. This means if you have a device that is new to market, the classification may be lower in the UK.
In Europe certain devices, such as reusable surgical instruments, many software devices, and some substance-based devices, are no longer Class I self-certified. Instead, they require a Notified Body issued CE Certificate. However, that device may still be Class I self-certified in the UK. The same is true for IVD products, which may now be Class B or C and require Notified Body intervention in Europe. However, they may be a General self-certified IVD in the UK.
This may allow companies to market faster in Great Britain under UKCA marking, while they work on their Notified Body issued CE Marking certification.
Devices that have been UKCA marked under the current legislation, will be granted a transition period before they must comply with the upcoming, more stringent, regulation. Currently, the expected transition period is:
The caveats are:
Therefore, there may be an advantage to UKCA marking early. You may be able begin marketing your new devices in the Great Britain, generating sales, while you undergo CE Marking in Europe.
The new UK regulations will also up-class devices, similarly to the EU MDR/IVDR. Therefore, if a manufacturer wishes to take advantage of the current “self-certification” process, they should UKCA mark and register their device(s) with the MHRA prior to the new regulation. The new regulation is currently expected to be implemented July 2025.