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Timeslines: Uk registration of new CE-marked SARS-CoV2 rapid antigen test

  • 1.  Timeslines: Uk registration of new CE-marked SARS-CoV2 rapid antigen test

    This message was posted by a user wishing to remain anonymous
    Posted 15-Nov-2021 09:42
    This message was posted by a user wishing to remain anonymous

    Hello,

    My company wants to register in the UK a new SARS-CoV2 rapid antigen test that has been CE-marked.
    As the medical device regulation 2002 has been changed in July for Covid-19 tests, this requires now the approval through a specific registration procedure.

    Does anyone here have any idea/experience how long it would take from submission to approval?

    Thanks in advance.


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