Hello Andrew,
As always, Kevin provides great information which I can not really contribute too much more. Basically: appraisal = quality of the data source, analysis = how it meets safety and performance (and maybe State of the Art) objectives. What I wanted to comment is in your clinical evaluation plan, it is becoming more and more apparent ... and I will say expected ... there is a "plan" for how appraisal is done and how analysis is done. When putting together a clinical evaluation plan, the "appraisal plan" is how you determine the quality of the data source, meaning is it used or not used (or you can use terms of included or excluded). The old Rev 3 of 2.7/1 had the charts in there which is still commonly used - but definitely recommend tailoring the appraisal methods to type of device and type of data source. Another comment is appraisal should be for all data sources and not just clinical literature, such as adverse events or clinical investigations. Then the "analysis plan" is how a data source can contribute to the safety and performance. Honestly, the analysis plan is a put more loose in my view where basically each of the data sources is explained how it contributes going back to meeting the safety and performance objectives (and state of the art). This can be done using tables for literature, using statistics (like PMS data), using quantitative reporting for clinical investigations, or using narrative such as review of clinical literature.
------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------
Original Message:
Sent: 18-Aug-2021 16:08
From: Kevin Randall
Subject: Appraisal Plan/Analysis Plan - Difference
The purpose of the appraisal step is to determine the basic value of the portfolio of clinical data identified as pertinent. The appraisal is to assess each individual document in terms of its scientific merit and validity for contribution to the evaluation of the clinical performance and clinical safety of the device. Plan and do this by:
- evaluating the methodological quality of work done by the clinical data authors and from that, the scientific validity of the information;
- determining the relevance of the information to the clinical evaluation, and
- systematically weighting the contribution of each data set to the clinical evaluation.
The foregoing appraisal process is to answer the question "Are the identified clinical data appropriate for inclusion in the clinical evaluation considerations?"
In contrast, the analysis step is to analyze the appraised (i.e., vetted and selected) clinical data sets to see if the clinical data collectively demonstrate conformity with relevant general safety and performance requirements pertaining to the clinical performance and clinical safety of the device, when the device is used according to its intended purpose.
------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, Canada, U.S)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
Original Message:
Sent: 18-Aug-2021 13:39
From: Andrew Devitt
Subject: Appraisal Plan/Analysis Plan - Difference
Hello all, I'm going back and forth with myself trying to nail down the difference between the appraisal plan and the analysis plan for a clinical evaluation report for a low risk class II device. . There really is not a ton of guidance in MEDDEV 2.7/1 rev 4. Does anyone have any wisdom on how they generally go about making these two distinctly different things?
Thank you,
Andrew Devitt
------------------------------
Andrew Devitt
New Prague MN
United States
------------------------------