Archiving period for data from clinical investigations
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I'm struggling to find an answer to this and was hoping someone could point me in the right direction? How long does the data from a clinical trial of a CE marked device need to be retained and are these requirements different for clinical investigations that will feed into an application for a CE mark?
Please see Annex XIV (final paragraph) of the new draft directive 93/42/EC final concept 2012. Also check with local regulations and ask your Notified Body. They should know and be able to help you.