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  • 1.  UK Responsible Person Symbol

    Posted 12-Jan-2021 04:05
    Dear all,

    Does anyone heard news of a UK Responsible Person symbol being developed like the Authorized Representative in the European Community (EC REP) symbol, from ISO 15223-1:2016? The guidance on UK.GOV only specify the UKCA symbol so far.

    Thank you.
    Looking forward to your thoughts.


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    Maisa Raposo
    Regulatory Affairs Specialist
    Cytiva
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  • 2.  RE: UK Responsible Person Symbol

    Posted 13-Jan-2021 05:26
    Edited by Richard Vincins 14-Jan-2021 09:26
    Maisa,

    Edit:  The name and address of UK Responsible Person needs to be on the labelling (which could may be the direct device label or IFU, not quite clear, but would do both):  'The name and address of the UK Responsible Person, where applicable, must be included on product labelling where the UKCA mark has been affixed.' There is no symbol or similar designation for the UK Responsible Person (... yet).  Supposedly they are still updating the regulations from the 2002 version post leaving the EU, but it should be included in there and whether or not a symbol will be made is unclear.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: UK Responsible Person Symbol

    This message was posted by a user wishing to remain anonymous
    Posted 14-Jan-2021 08:56
    This message was posted by a user wishing to remain anonymous

    Maisa, 

    There's a requirement for Manufacturers from outside the UK to add the UKRP person information in either the labels or IFU's.
    As far as I know, there is no logo published yet.
    Original Message


  • 4.  RE: UK Responsible Person Symbol

    Posted 21-Jan-2021 05:09
    Thank you all for your comments! Yes, apparently there is nothing about a UK Responsible Person symbol yet.

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    Maisa Raposo
    Regulatory Affairs Specialist
    Anaheim CA
    United States
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    Original Message


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