Dear Ponzelle,
I recommend a report format structured according to the examples in the annex of MEDDEV 2.7.1. Rev.3. However, this should not be over-evaluated as the MEDDEV recommendation is not in all senses 100% usable.
What should be included?
1. Objective of your clinical evaluation
2. Plan of how you want to identify data
3. Documentation of how you identify data (including reasons for excluding data)
4. Appraisal and Analysis of data (Use tables to make it structured and easy to get an overview)
5. Final report including conclusions and (if necessary) recommended actions
6. Documentation of the authors qualification (and more and more Notified bodies ask for that: the reasons for choosing the author/s)
As far as 6 is concerned: To my experience, it is advisable to include a physician in the process of data evaluation, but it is not necessary to let a physician do the major part of the work. Most of the time, people that are good with data research and a "pre-evaluation" are much faster with this and it will be very hard to find a physican who would want to do this work.
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Florian Tolkmitt
sfm medical devices GmbH
Germany
florian.tolkmitt@sfm.de -------------------------------------------
Original Message:
Sent: 02-26-2013 10:34
From: Ponzelle Royster
Subject: Clinical Evaluation
We recently had a Technical File Review by our Notified Body and one of the observations was that the clinical evaluation did not establish a more stringent adherence to MEDDEV 2.7.1 with regards to the literature search methodology and evaluation report format.
Our evaluation report did reference a body of relevant literature but the search was not identified. Does the analyses and/or evaluation of post market information have to be performed by medical expertise; specifically a physician?
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Ponzelle Royster RAC
Duluth GA
United States
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