The MDD allows you to waive the clinical evaluation for devices where it is not appropriate:
From Annex X: "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.".
Just add a memo to your Technical documentation giving adequate justification for the exclusion based on risk, history of safe use, performance intended, claims, etc. I am assuming conformance to the Essential Requirements for your products is not based on any clinical evidence.
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Carrie Termin MS
Buffalo Filter
Lancaster NY
United States
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Original Message:
Sent: 04-21-2014 20:19
From: Laurie Cartwright
Subject: EU Class I Device Clinical Evaluation
We have a number of Class I reusable surgical instruments for which we can find little-to-no published literature to support a clinical evaluation for the Technical Files. These devices, like many other reusable surgical instruments, are not the subject of evaluation by physicians because they are ancillaries/accessories to other higher risk devices and/or procedures. Think scalpel, drill, probe, etc. How are others dealing with clinical evaluation documentation for such Class I devices? Note that it is not practical to undertake human clinical evaluations for these types of devices, so I'm looking for ideas on how we can handle these similarly to devices for which we can find related published literature.
Thank you-
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Laurie Cartwright
Irvine CA
United States
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