Archiving Costs for Medical Device Trials

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  • 23 June 2021 at 11:45 am #3467

    Hi there,

    Does anyone know the required archiving period for medical device trials (non-CE marked)?  I can’t find it in the current UK legislation (SI 2002/618) or in the new EU medical devices regulation due to be implemented in 2020 …

    I know the archiving period in the the new CT regulation is 25 years, but don’t think device trials fall within the scope of this regulation.

    Thanks in advance for any help!

    Jennifer

     

    Jennifer MacPhee
    Quality Manager
    Robertson Centre for Biostatistics
    University of Glasgow
    Tel: 0141 330 3122
    http://www.gla.ac.uk/researchinstitutes/healthwellbeing/research/robertsoncentreforbiostatistics/
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