Hi Emily,
Thanks for the interest, the audit went well – a few minor NCs (would have been surprised if none in a level 3), but all corrected to auditor’s satisfaction. With respect to the clinical evaluation, he made an observation (OFI) that some of the references I used did not show clearly enough the connection to the device in question. He was happy with the approach however. Your more detailed analysis (as you indicate) is based on NB-MED 2.7 – Clinical Investigations, Clinical Evaluation – i.e. in my eyes this means citing ‘clinical trials’ literature, totally different animal (see BS EN ISO 14155-1) – thus the authorship etc requirements – not a good idea. I have used
MEDDEV 2.7.1 for my approach – I think you should have a look at this instead. So anyway, post audit, what I have done now is that for each reference cited, I have included either an abstract (all I could find in a number of cases) or a short precise of the article/book chapter – with pictures, diagrams etc as these often clearly show design or use equivalence. This document is therefore much more complete as you request, but has become a bit too specific and confidential to easily share a completed example.
All this said, I like your citation hits and applicability, because I do something very similar as I monitor alerts, recalls, advisory notices (FDA, MHRA, TGA, MDB, BfArM, Afssaps etc) as part of my post market surveillance.
For clinical evidence definitions, if not already done so, check out SG5/N1R8:2007 and SG5/N2R8:2007 at the GHTF website
Hope this helps.
Steve