Clinical evaluation plan

LAM2020

Starting to get Involved
#1
Hello,
is tehre someone willing to share their clinical evaluation plan? a template. I am stuck on the first requirement:
— an identification of the general safety and performance requirements that require support from relevant clinical data;
What do they mean by that? please help.
Thanks
 
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Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#4
I cant provide everything but this is an outline of ours

  • Clinical investigations that are conducted by or on behalf of COMPANY XXX are performed on the basis of an investigational plan that includes or reflects:
  • A clear statement of objectives and claims
  • Appropriate subject population(s) and methods for selecting study subjects, including their suitability for the study and that confirmatory laboratory tests where appropriate
  • Methods for observing and recording results
  • Methods for analyzing and evaluating results, including statistical methods
  • Randomization, anonymization, minimization of bias, and the use of control groups where appropriate
  • All appropriate device features, including those involving the safety and performances of the device and its effect on patients
  • The latest scientific and technical knowledge
  • Diagnostic criteria of any condition to be treated or diagnosed, including evidence of susceptibility and exposure to the condition
  • Identification of confounding factors (e.g., concurrent medications, comorbidities)
  • Choice of appropriate controls (e.g., cohort, sham, historical), where necessary
  • Design configuration (e.g., parallel, crossover, factorial)
  • Type of comparison (e.g., superiority, non-inferiority, equivalence)
  • The ability of study results to confirm or refute claims for the device
  • Sufficient observations to guarantee scientific validity
 

monoj mon

Trusted Information Resource
#9
Do you by any chance an exemple ?
Combining all of these, I believe, should provide a robust 'Clinical Evaluation Plan and Clinical Evaluation Report'.
MDCG 2020 - 13 Guidance
Find CEP overview - Clinical Evaluation Plan SOP file.
this is an outline of ours
GalitSa's template should help you to a great extent. While you collect other literatures, collection of updated information (IFU, marketing materials, etc.) regarding the 'claimed equivalent device' is an important part to establish the equivalence. Also, try to find an equivalent device which has been in clinical use and results have been published. Although, keep in mind that in the MDCG 2020 - 13 Guidance it is mentioned not to use your device name or equivalent device name as a search criteria to avoid limiting your search. So, try to find a mostly used equivalent device which has a greater chance of appearing in the literature search.
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Feel free to keep posting in this thread, if you get any further questions. Although people here may not be able to share emplates, but at least could check if you are in the right direction.
 
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