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  • 1.  Procedure Packs in the UK

    This message was posted by a user wishing to remain anonymous
    Posted 29-Nov-2022 11:25
    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:
    1. 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?
    2. 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!


  • 2.  RE: Procedure Packs in the UK

    Posted 30-Nov-2022 00:57
    Hello Anon,

    I am not sure you will find a definitive answer currently because of the flux in the UK regulation.  Currently, the UK Medical Device Regulations (UK MDR) are aligned to the EU MDD 93/42/EEC so procedure packs listed under Article 11.  The new regulation is hopefully expected by mid-next year.  The reason you are finding it unclear for the UK MDR is this is still the older requirements which are not aligned or similar to the current EU MDR.  If you are going to mix-n-match UKCA Mark products with CE Mark products ... not really clear.  However, what is clear is CE Mark products can be sold in the UK until June 2023 (though will probably be June 2024).  If your procedure pack products within the pack contain either CE Mark, UKCA Mark, or combination of both, what is clear is all the products are "approved" so should be able to be legitimately distributed and sold.  It has always been the case IVD medical device products can be sold with medical device products in a procedure pack; or usually more precisely medical devices are sold in a pack with IVD medical devices for specimen acquisition.  This is acceptable as long as each product bears the proper conformity designation.  If a medical device is not CE Marked or not UKCA Marked, sold in a "pack" or kit with an IVD medical device, then the whole pack or kit would need to bear a CE Mark/UKCA Mark.

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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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  • 3.  RE: Procedure Packs in the UK

    Posted 30-Nov-2022 04:11
    I concur with Richard, detailed information on procedure packs for the UK market is scarce. It looks likely that the future UK regulations will mirror (mostly) the EU MDR requirements for procedure packs, but for now Richard has described the current situation.

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    Ed Ball
    Manager, Intelligence & Innovation
    United Kingdom
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  • 4.  RE: Procedure Packs in the UK

    This message was posted by a user wishing to remain anonymous
    Posted 30-Nov-2022 09:29
    This message was posted by a user wishing to remain anonymous

    Thank you both. So the intention is to market a procedure pack which consists of a combination of UKCA and CE-marked products, at least for the 12 months. The approved products are also a combination of 1 medical device and 3 IVDs. Based on what you have both said, this seems possible with the current regulations. Once the new UK regulations have been implemented, we will need to have all components UKCA approved. Is that correct?

    This has been super helpful. Thank you!


  • 5.  RE: Procedure Packs in the UK

    Posted 30-Nov-2022 13:19

    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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