It is official. The MHRA announced that they will extend the CE Marking transition period for another 3-5 years, after the new UK Medical Device Regulation goes into effect. Further, that they will postpone the new UKCA regulation by one year.
The title of the MHRA’s update is “Implementation of the future regulation of medical devices and extension of standstill period” and you can read the official update: HERE
What is the implementation date for the new UK Medical Device Regulation (UKCA Marking)?
The MHRA will delay implementation of the new Medical Device Regulation on UKCA Marking by one year.
The original implementation date was scheduled for July 2023, and it is now scheduled for July 2024.
“The future Medical Device Regulations is a substantial reform of the current framework as outlined in 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.”
Until then, CE Marked devices may continue to be placed onto the market.
And of course, manufacturers may UKCA Mark to the current version of the regulation today if they wish. They do not need to wait for the new version of regulation to be implemented. If they do so, then those devices UKCA Marked under the “old” regulation will be eligible for a transition period, before they must comply with the new version of the UK regulation.
NOTE: this does not exempt manufacturers from registering their devices, whether UKCA or CE Marked, with the MHRA. Non-UK manufacturers must appoint a UK Responsible Person to perform this registration on their behalf.
To learn more about the current compliance requirements, please read: UK Responsible Person, MHRA Medical Device Registration Requirements
To learn more about the upcoming new UK Regulation, please read: New UK Regulations
What does this mean for the CE Marking acceptance transition period?
Once the new UK Regulation is implemented, then the transitional arrangements will begin to apply.
“Manufacturers will be able to continue to place CE marked devices on the Great Britain market after 1 July 2023. From July 2024, the transitional arrangements will apply for CE and UKCA marked devices placed on the Great Britain market.”
The Government’s Transitional Arrangements for UKCA and CE Marked devices can be read in full: HERE
As Casus previously reported, the MHRA intends to allow a further five (5) year transition period to accept MDR, IVDR and IVDD CE Marked devices. And a further three (3) year transition period for MDD and AIMDD CE Marked devices.
Therefore, if the new UKCA Marking regulation is implemented in July 2024, then the transition period for CE Marked devices is as follows:
MDR, IVDR and IVDD CE Marked devices – five (5) year transition period after the new regulation takes effect, i.e., July 2029
MDD and AIMDD CE Marked devices – three (3) year transition period after the new regulation takes effect, i.e., July 2027
Devices UKCA Marked under the current regulatory framework will have the following transitional period:
UKCA Marked medical devices – three (3) year transition period after the new regulation takes effect, i.e., July 2027
UKCA Marked IVDs – five (5) year transition period after the new regulation takes effect, i.e., July 2029
The caveats outlined for both CE Marked and UKCA Marked devices are as follows:
- “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”
Note that the above dates are applicable only if the device UKCA or CE Marking is valid and not expired.
New UK Post-market Surveillance Requirements to be implemented in 2023
The MHRA intends to introduce new Post-market Surveillance (PMS) legislation in early 2023.
While the new UKCA Marking regulation will be delayed until July 2024, it is the MHRA’s intent that the new PMS requirements will be enforced before the new regulation. You can read more about the new PMS requirements: HERE
“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.”
Casus will report more on this topic, as information becomes available.
The MHRA will soon update its ‘Regulating Medical Devices in the UK’ guidance to reflect the new timeframes.
In the meantime, manufacturers will have a further time period before they must comply with the new UKCA Marking requirements. Instead, they may continue to access the UK market leveraging their European CE Marking, as long as they meet the other UK requirements, such as appointing a UK Responsible Person (UKRP) and registering their devices with the MHRA.
For more information on the differing UK requirements between Northern Ireland and Great Britain (England, Scotland, Wales), please read: Northern Ireland Medical Device Requirements