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Registration with MHRA

Discussion in 'EU Medical Device Regulations' started by fialor, Sep 6, 2016.

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  1. fialor

    fialor Member

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    Hi Everyone
    My company is beginning to place class IIa and IIb devices on the EU market and we are based in the UK as a UK manufacturer. Do I need to register the company with MHRA as a manufacturer based in the UK?
    I know I do not have to register the devices as they are not class I but it is still unclear for me on the manufacturer registration front.
    Any information would be much appreciated.
    Thanks
     
    fialor, Sep 6, 2016
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  2. Steve Kent

    Steve Kent Member

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    I assume you have a notified body, so the answer is no. Before Medical Device Directive came into effect you did have to register with what was then the Medical Devices Agency.

    Steve
     
    Steve Kent, Sep 6, 2016
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  3. fialor

    fialor Member

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    Yes - we do as we are annex II.
    Thanks for clarifying.
    Fialor
     
    fialor, Sep 6, 2016
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