Archiving Requirements For Medical Device Trials

Hi,

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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