Regulatory Open Forum

 View Only
  • 1.  UK and UK Approved Bodies designation codes?

    Posted 17-May-2022 10:25
    Hi,

    Probably a dumb question but I'm having trouble finding it...

    Where can I get a current list of the designation codes for UK Approved Bodies? I found an old NBOG document from 2009 (NBOG BPG 2009-3), but it does not have all the current codes. MDR and IVDR have implementing act documents with the new codes, but where can I find the old ones for the directives (AIMDD, MDD, IVDD)? Or has UK published a list anywhere?

    Thank you,

    ------------------------------
    Corey Jaseph RAC
    Senior Research Analyst
    Wheatland CA
    United States
    ------------------------------


  • 2.  RE: UK and UK Approved Bodies designation codes?

    Posted 17-May-2022 11:03
    Hi Corey

    They have a database online:
    https://www.gov.uk/uk-market-conformity-assessment-bodies


    ------------------------------
    Anne LeBlanc
    United States
    ------------------------------



  • 3.  RE: UK and UK Approved Bodies designation codes?

    Posted 18-May-2022 04:25
    Hi Corey

    I don't think a full list has been published by the MHRA. The codes being used are the old codes for the Directives as listed in the NBOG document you referred to. As can be seen in the scope designation documents: https://www.gov.uk/government/publications/medical-devices-uk-approved-bodies/uk-approved-bodies-for-medical-devices

    What do you mean by 'new codes'? Do you mean a UK equivalent of the MDR/IVDR designation codes?

    ------------------------------
    Edward Ball
    Manager, Intelligence & Innovation
    United Kingdom
    ------------------------------



  • 4.  RE: UK and UK Approved Bodies designation codes?

    Posted 18-May-2022 11:49

    Thanks for your responses, Anne and Edward.

    Meaning that BSI, for instance, has been designated for codes that aren't listed in the NBOG BPG 2009-3 document: MD 0110, MD 1112, as examples. So I know the NBOG document is not current (i.e., does not contain all the codes currently in use for UK Approved Body designation).

    I was wondering if there were somewhere else to get a complete list of the designation codes for IVDD, MDD and AIMDD. The NANDO database doesn't provide a separate list, as far as I know, but just the scopes of designation of all CABs.

    Does that make sense?



    ------------------------------
    Corey Jaseph RAC
    Senior Research Analyst
    Wheatland CA
    United States
    ------------------------------



  • 5.  RE: UK and UK Approved Bodies designation codes?

    Posted 18-May-2022 12:59
    Hi Corey

    I'm not sure if I'm understanding...

    For UK approved bodies, the EU NBOG doesn't apply.

    For EU notified bodies, still designated for the directives, there are NANDO lists available here:
    https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.main


    https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.pdf&refe_cd=93%2F42%2FEEC
    https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.pdf&refe_cd=98%2F79%2FEC
    https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=8


    ------------------------------
    Anne LeBlanc
    United States
    ------------------------------



  • 6.  RE: UK and UK Approved Bodies designation codes?

    Posted 20-May-2022 11:12
    Hi Corey,

    Yes it does make sense. I don't think there is a list to point to, especially not for the UK. The codes used in the UK Approved Body listings are the same codes used for the 3 Directives that can be found in NANDO or in the summary sheets for each directive, e.g. here. 


    ------------------------------
    Edward Ball
    Manager, Intelligence & Innovation
    United Kingdom
    ------------------------------



  • 7.  RE: UK and UK Approved Bodies designation codes?

    Posted 20-May-2022 16:18
    Thank you for the help, Anne and Edward. Sounds like the UK doesn't have a public list of all the codes they designate UK Approved Bodies to, unlike the implementing act of the MDR and IVDR codes used for designation under the new regulations.

    ------------------------------
    Corey Jaseph RAC
    Senior Research Analyst
    Wheatland CA
    United States
    ------------------------------



  • 8.  RE: UK and UK Approved Bodies designation codes?

    This message was posted by a user wishing to remain anonymous
    Posted 21-Jun-2022 09:48
    This message was posted by a user wishing to remain anonymous

    Hi Corey,

    The codes for the UK Approved Bodies haven't been released yet. The UK MDR has been amended for the UKCA Mark and those amendments have yet to be released. When the amendments are released, the designation codes for the UK Approved Bodies should be released around that time.


  • 9.  RE: UK and UK Approved Bodies designation codes?

    Posted 21-Jun-2022 10:37
    Perfect, thank you. I will keep waiting. :)

    ------------------------------
    Corey Jaseph RAC
    Senior Research Analyst
    Wheatland CA
    United States
    ------------------------------