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Registration with MHRA

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

  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
     
  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
     
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  3. fialor

    fialor Member

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    Yes - we do as we are annex II.
    Thanks for clarifying.
    Fialor
     

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