The MHRA announced on October 25th 2022, that they “are introducing a 12-month extension to the implementation of the future Medical Device Regulations, to bring the new regulations into force by July 2024.”
This is on top of the 3 to a 4-year extension of the CE Marking transition and a delay in the new UKCA regulation by one year.
What is the new implementation date for UKCA Marking (UK Medical Device Regulation)?
The MHRA has delayed the implementation of the new Medical Device Regulation on UKCA Marking for 12 months.
The original implementation date was July 2023, now July 2024.
The official statement from the MHRA is as follows:
“The future Medical Device Regulations is a substantial reform of the current framework as outlined by the government response. We are therefore introducing a 12-month extension to the implementation of the future Medical Device Regulations, with an aim to bring the new regulations into force by July 2024.”
This means that CE-marked devices can continue to be placed on the market until July 2024.
This does not mean that if you are a UK manufacturer, you must wait until the new version of the regulation is implemented before you UKCA mark your device. You can UKCA mark your device to the current regulations, as they will become eligible for a transition period before they must comply with the new UKCA Marking regulations.
It is important to remember that as a manufacturer, you must register your medical device with the MHRA, whether they are CE Marked or UKCA Marked. If you are a non-UK manufacturer, you must appoint a UK Responsible Person to register this on your behalf.
What about the CE Marking acceptance transition period?
Once the new UK regulation has been implemented in July 2024, the transition period will come into effect.
The MHRA stated: “Manufacturers will be able to continue to place CE-marked devices on the Great Britain market after July 01st 2023. From July 2024, the transitional arrangements will apply for CE and UKCA marked devices placed on the Great Britain market.”
The MHRA intends to allow a further 5-year transition period for accepting IVDD, IVDR and MDR CE Marked devices. There will also be a 3-year transition period for AIMDD and MDD CE Marked devices.
The critical dates for CE Marked devices, therefore, are:
- July 2027 for AIMDD and MDD CE Marked devices
- July 2029 for IVDD, IVDR and MDR CE Marked devices
The critical dates for medical devices that are currently UKCA Marked are:
- July 2027 for UKCA Marked medical devices
- July 2029 for UKCA Marked IVDs
There are some caveats attached to both the CE Marked and UKCA Marked device transitionary period:
- All post-market requirements applicable to the new regulatory framework must be complied with for all products which benefit from the transitory arrangements.
- Devices subject to significant changes in design or intended purpose will be excluded from these provisions.
It is also important to remember that the dates outlined above are only applicable if your device’s CE or UKCA Marking is still valid.
New UK Post-market Surveillance Requirements will be implemented in 2023
The MHRA will introduce new Post-market Surveillance (PMS) legislation in 2023 before the new UKCA Marking regulations are enforced.
The MHRA said: “Bringing into force the new post-market surveillance requirements ahead of the wider future regulatory regime reflects the government’s priority of improving patient safety as part of the future Medical Device Regulations.”
Summary of key dates
- January 1st 2022 – The deadline to register existing UK-sold devices with the MHRA
- July 1st 2024 – Conformity assessment as per UKCA legislation becomes mandatory
- June 20th 2024 – CE Marked devices can be placed on the UK market until this date or until the CE Certificate expires.
- June 30th 2024 – All devices placed on the GB market must have a UKCA Mark. Also, labels and IFUs have to meet the UKCA requirements.
We will keep you updated on all the latest announcements on our blog.