Clinical Evidence - Clinical Evaluation Report for Class I medical devices

medwise

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#1
Hello Experts,

I'm currently in the process of authoring clinical evaluation report for class I medical devices for table accessories and attachments (side rails, clamps, head support, upper and lower limb). I'm struggling to find papers supporting the clinical relevance of these devices.

I understand that it is a requirement for a medical device manufacturer to have a clinical evidence in the technical file addressing section 14 of Essential Requirements.

Can someone advise how I can be compliant with regulatory requirements for this kind of device? Am I required to go to an extent of literature search strategy (inclusion & exclusion criteria), critical appraisal, risk benefit etc. for a table accessories and attachments?

PS - I've drafted CER for class IIa and IIb devices which has been accepted by various regulators. I'm finding class I to be a challenging one:(

Thank you in advance.
 
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Ronen E

Problem Solver
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#2
If these elements are long established and published standards exist, you can relate to that instead of looking for literature (provided that you comply). Alternatively, you can refer to books and other design guides (if they exist) if the subject matter is "traditional" and well-understood (with no or little novelty).
 
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