MHRA Statement: Impact of the EU Commission’s MDR Extension in the UK
February 20, 2023
Class B/C IVD Deadline to Appoint Swiss Authorized Rep: 31 Mar 2023
March 1, 2023Page Last Updated: 29 August 2023
In Short: Yes, there are some advantages to UKCA Marking early, particularly for low-risk devices.
Background
When the UK left the European Union, 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 Directives (MDD/AIMDD/IVDD).
The MHRA announced at the time of withdrawal that they would implement their own medical device assessment process (“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 later 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
Current Regulatory State
NOTE: from a regulatory perspective, the UK is made up of two territories: 1) Great Britain (England, Scotland, Wales) and 2) Northern Ireland. 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:
- Either CE Mark or UKCA Mark their device
- Register their company and devices with the MHRA
- If the manufacturer is not located in the UK, then they must appoint a UK Responsible Person (UKRP), who must complete this registration on the manufacturer’s behalf
For more information on the requirements, please read: UK Medical Device Registration and UK Responsible Person
CE Marking will be allowed until:
- MDR, IVDR and IVDD CE Marked devices – 30 June 2030 or the CE Certificate expires, whichever is sooner
- MDD and AIMDD CE Marked devices – 30 June 2028 or the CE Certificate expires, whichever is sooner
Currently there are less than 10 UK Approved Bodies designated to issue UKCA Marking certificates. The list of UK Approved Bodies is available: HERE
UKCA Mark Fact Sheet
UKCA Marking deadlines; UKCA versus CE Marking technical file and labeling differences; where to download the symbol; and more.
Future Regulatory State
Unless a further extension is granted, UKCA Marking will be mandatory for all medical devices and IVDs in Great Britain by 30 June 2030.
Why UKCA Mark early, if CE Marking is still accepted?
For most companies, it is logical to continue marketing with their EU CE marking. The reasons include:
- Your regulatory resources may be busy with MDR transition activities
- None of the UK Approved Bodies may yet be designated for the product code that requires certification
- You may decide to wait for the new regulations to go into effect before implementing UKCA marking requirements, to avoid implementing under the current version of the regulation and then having to upgrade later
However, there is an instance in which it may be particularly beneficial to UKCA mark early. This is related to device classification.
Device Classification in Great Britain versus the EU
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, C or D and require Notified Body intervention in Europe. However, they may still 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 EU 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:
- UKCA Marked medical devices – three (3) year transition period after the new regulation takes effect, i.e., sometime in 2028
- UKCA Marked IVDs – five (5) year transition period after the new regulation takes effect, i.e., sometime in 2030
The caveats are:
- “devices that are subject to significant changes in design or intended purpose will be excluded from these provisions”
- “all post-market requirements applicable to the new regulatory framework must be complied with for all products which benefit from the transitionary arrangements”
Therefore, there may be an advantage to UKCA marking early. You may be able to 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.
