Scope and plan of the clinical Evaluation

#1
Hi
I'm a trainee in the medical device regulatory affairs and I'm writing the clinical evaluation report according to the Meddev rev 4 and I couldn't understand the difference between the scope and the plan of clinical evaluation :confused: :confused: :confused:
Could someone explain it to me ?
thank you :) :)
 
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paulag

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#2
Hi Riri,

the Meddev explains the scope ... which device, under which directive, the essential requirements that you need to cover with the clinical evaluation, etc. For the plan, there is an example on page 15, regarding which aspects you plan to consider in which phase
 
#3
This is a very good question actually. Our NB asked for a separate stand-alone clinical evaluation plan even while still under MDD, but really it is only clear under MDR. If still under MDD, I'd be forever grateful to anyone who can help clarify/translate MDD for me. What are the units of the "clinical evaluation plan" ? [eg. one is written for the entire life cycle and is very generic; or is one written, based off a generic checklist SOP of the evaluation process, any time a triggering event-e.g.device mods, per 2 year schedule- occurs?]
 

Ronen E

Problem Solver
Staff member
Moderator
#4
This is a very good question actually. Our NB asked for a separate stand-alone clinical evaluation plan even while still under MDD, but really it is only clear under MDR. If still under MDD, I'd be forever grateful to anyone who can help clarify/translate MDD for me. What are the units of the "clinical evaluation plan" ? [eg. one is written for the entire life cycle and is very generic; or is one written, based off a generic checklist SOP of the evaluation process, any time a triggering event-e.g.device mods, per 2 year schedule- occurs?]
Under the MDD, the MEDDEV (rev 4) is the best guidance, and it should answer all your questions. There are also a lot of free online related resources - interpretations, presentations (including video) etc.
 
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