The MHRA accepts CE Marked devices and UKCA Marking will not become mandatory until July 2024. The original date was July 2023; however, the MHRA has granted a one-year "extension of the standstill period". The MHRA announcement from October 25, 2022, is here: https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices-and-extension-of-standstill-period/implementation-of-the-future-regulations
However, even then, CE Marked devices will have a further allowance in Great Britain*. When the new UKCA Marking regulation goes into effect it includes a transition period. The transition period allows IVDD and IVDR CE marked devices access to the UK market for another five years after the new regulation goes into effect. Therefore, if the new regulation goes into effect in July 2024, as currently planned, then IVDD/IVDR CE Marked devices can remain on the market in Great Britain until July 2029. When we state IVDD CE Marked devices, this means devices that have valid CE marking, i.e., legacy devices eligible to be legally marketed after the IVDR date of application. After July 2029, devices require UKCA marking in order to remain on the Great Britain market.
Therefore, yes, you can register your procedure pack with CE-marked devices. That said, regarding mixing UKCA and CE-marked devices, this may be an issue because the MHRA registration application requires you to select the applicable conformity assessment route. When you select your application type as 'System or Procedure Pack', you have to select either MDD or MDR. Then, when uploading the Procedure Pack Statement, you will need to identify if the pack is CE marked, UKCA marked or CE (UK NI) marked. Further, the UK's registration application does not have the option to select an IVD Kit. Only General Medical Device, IVD, AIMD or System/Procedure Pack under either UK MDR 2002 (Art 12 of the MDD) or MDR (Art 22).
If in doubt, you may wish to ask the MHRA directly at Device.Registrations@mhra.gov.uk. Otherwise, if you submit the application and the MHRA assessor finds any issues with the application, if they are nice they will ask you for corrected information. Or, they could simply reject the application and ask you to resubmit, though they generally let you know why so that you can make the appropriate corrections in the next application.
*UKCA marking only applies in England, Scotland, Wales (Great Britain). Northern Ireland, the fourth UK country, currently requires, and will continue to require, CE Marking.
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Sydney O'Connell
Dallas TX
United States
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Original Message:
Sent: 29-Nov-2022 11:06
From: Anonymous Member
Subject: Procedure Packs in the UK
This message was posted by a user wishing to remain anonymous
Hello,
I am working the Technical File for a Procedure Pack in the UK. Does anyone have guidance on the following:
- Due to the extension of the legislation, are all components in the procedure pack required to have a UKCA mark or can these bear a CE mark?
- Can you package IVDs with medical devices under UK MDR?
The EU MDR is explicit in explaining the requirements for Procedure Packs when it comes to IVDs and Medical Devices, but it is still unclear for the UK MDR.
Thank you in advance for the help!