I was talking about the MDD, not the MDR. Please check mdd 93/42/eec amended by 2007/47/ec.
Back to the discussion:
1.1d Where demonstration of conformity with essential requirements based on clinical data is not deemed appropriate, adequate justification for any such exclusion has to be given based on risk management output and under consideration of the specifics of the device/body interaction, the clinical performances intended and the claims of the manufacturer. Adequacy of demonstration of conformity with the essential requirements by performance evaluation, bench testing and pre-clinical evaluation alone has to be duly substantiated.
Back to your original question, you'd have to fully rely on performance / bench testing / pre-clinical evaluation results only if you are trying to avoid demonstrating ER conformity based on clinical data. Is that your situation?
Either way, regardless of Annex X contents, you have to demonstarate conformity with the ERs (typically in the ER checklist), and I assume you'd use anything relevant that you have to do so - performance evaluation results, bench testing results and any other - clinical or non-clinical - relevant results. If the data and analysis you have are adequate and the paper trail is traceable, I guess you should be fine. Anyway, I think that clause 1.1d doesn't really add much burden; it merely highlights the criticality of non-clinical data in establishing ER conformity where clinical data is not relied on (and not deemed necessary for that purpose).
Cheers,
Ronen.
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