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  • 1.  UK responsibile person registering our class 1 medical device products in MHRA system - help needed.

    Posted 26 days ago

    Hi, 

    We are a manufacturer of class 1 medical devices and we have appointed a UK-responsible person who is trying to register our products in the MHRA portal.

    As we do not have any custom devices or sterile products, can anyone help with what documentation we need to provide for this section?

    Many thanks 

    Lucy Robertshaw 



    ------------------------------
    Lucy Robertshaw
    CEO
    Holo
    Sweden
    ------------------------------


  • 2.  RE: UK responsibile person registering our class 1 medical device products in MHRA system - help needed.

    Posted 24 days ago
    Edited by Ronald Boumans 24 days ago

    Dear Lucy,

    Those category markers would probably be marked as 'non-applicable'. There are some great UKRPs out there, that have a wide experience in registering and all the other services required to make supply to the UK as  straightforward as possible. I don't know about your current UKRP, but I have the feeling that this is not one of them.



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    Ronald Boumans
    MDR Expert
    Super PRRC
    Netherlands
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    Original Message


  • 3.  RE: UK responsibile person registering our class 1 medical device products in MHRA system - help needed.

    Posted 24 days ago

    Hi Lucy,

    I agree with Ronald advice, those categories would be not-applicable, for guidance on Class 1 medical devices in the UK please follow the link 

    https://www.gov.uk/government/collections/guidance-on-class-1-medical-devices



    ------------------------------
    Tomasz Ciski
    Quality Associate
    Nemaura Pharma Limited
    Loughborough
    United Kingdom
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    Original Message


  • 4.  RE: UK responsibile person registering our class 1 medical device products in MHRA system - help needed.

    Posted 24 days ago

    Thanks for the confirmation in what I thought was the case and I am going to have a teams meeting today to see if I can see what they are doing so to get this moving in the right direction.



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    Lucy Robertshaw
    CEO
    Holo
    Sweden
    ------------------------------

    Original Message


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