June 2022: MHRA Delays UKCA Marking Deadline

New Guidance: EU Certificates of Free Sale

June 23, 2022

Approaching Deadline: Appoint Swiss Authorized Rep for Class I & System/Procedure Packs

July 1, 2022

The MHRA released its 155-page Government Response to the ‘Consultation on the future regulation of medical devices in the United Kingdom’.

Section 15 (Transitional Arrangements) delays UKCA marking, specifically:

1. UKCA marking will be postponed, i.e., have a longer transition period before it becomes mandatory
2. CE marked devices will continue to be allowed onto the market for a longer transition period

The original date for mandatory medical device UKCA marking was 1 July 2023. And the original last date by which CE marked devices could be placed onto the Great Britain market was 30 June 2023.

UKCA Marked Devices

If a device already has UKCA marking to the current UK regulation, a transition period will allow those products to be placed onto the market until:

- either the certificate expires or
- for three years after the new regulations take effect (in the case of general medical devices) or five years (in the case of IVDs), whichever is sooner

As a refresher, the current UK regulations are based on the old Directives . The MHRA’s new proposed regulation is similar, but not exactly aligned, to the MDR/IVDR.

What is the new compliance date?

The UK government response states that they still plan for the new regulations to come into force in 2023.

If that does occur, then the date by which the UKCA marked device must comply with the new regulation is 2026 for general medical devices and 2028 for IVDs, or the date the certificate expires, whichever comes first.

MDR/IVDR CE Marked Devices

These products may continue to be placed onto the market until:

- either the CE certificate expires or
- for five years after the new regulations take effect, whichever is sooner

The above will apply even if the CE Certificate / Declaration of Conformity is dated after the new UK regulations take effect.

The MHRA has left themselves the option to reevaluate if they will continue to accept MDR/IVDR CE marked devices even after that initial five-year transition period ends. But for now, it is either for as long as the CE Certificate is valid or five years after the new regulations take effect, and no longer.

What is the new compliance date?

The UK government response states that they still plan for the new regulations to come into force in 2023.

If that does occur, then the date by which manufacturers can continue marketing with their CE marking is 2028 or the certificate expires, whichever is first. After this date, the device must be UKCA marked in order to continue being placed onto the market.

MDD/AIMDD/IVDD CE Marked Devices

These products may continue to be placed onto the market until:

- either the certificate expires or
- for three years (for general medical devices) and five years (for IVDs) after the new regulations take effect, whichever is sooner

Same as MDR/IVDR CE marked devices, the transitional allowance will apply even if the CE Certificate / Declaration of Conformity is dated after the new UK regulations take effect.

What is the new compliance date?

The UK government response states that they still plan for the new regulations to come into force in 2023.

If that does occur, then the date by which manufacturers can continue marketing with their CE marking is 2026 for general medical devices* and 2028 for IVDs, or the date the certificate expires, whichever comes first. After this date, the device must be UKCA marked in order to continue being placed onto the market.

*Note that MDD/AIMDD CE marking no longer recognized as of 26 May 2024.

For more information on the MDD/AIMDD to MDR transition dates, please read: MDCG Cautions Industry: Don’t Delay MDR Compliance

For more information about the IVDD to IVDR transition dates, please read: IVDR Round-up: EU, Switzerland and UK

Caveat to the Transitional Provisions

First, the above transition does not exempt companies from the need to register themselves and their devices with the MHRA. Non-UK companies must appoint a UK Responsible Person (UKRP) who will complete the mandatory registration on their behalf.

As well, and similar to MDR/IVDR transitional provisions for EU ‘legacy’ devices, the UK Government Response states:

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 will need to be complied with for all products which benefit from the transitionary arrangements

Further, all of the above information is related to Great Britain only. Northern Ireland requires, and will continue to require, CE marking. Northern Ireland will not recognize UKCA marking.