Hello Anon,
I would agree with Ms. Grell; there is certainly no magic number, and your total screening obligation can depend on a variety of factors, such as the history of your device and device technology as well as the methods (e.g., key words and phrases) used to detect relevant articles. In a recent article on the notified body perspective (linked below), it is recommended that searches for the device under evaluation (DUE), equivalent device, and device technology (i.e., state of the art; SotA) be described separately. As such, the RQM+ team has been developing separate research questions (i.e., PICO tables) and, accordingly, search strings for each of these (DUE and SotA) search efforts. I generally expect the screening obligation to vary by search effort, with the SotA search often returning more articles than the DUE search; although, this can depend on the market history of the DUE. To my knowledge, RQM+ has not received any notified body feedback on the number of articles returned by either search; however, we have responded to feedback regarding the search string justification, where there was concern that the results of a search were not comprehensive. To avert this type of feedback, the RQM+ team validates its search strings, as a best-practice, using gold standard articles (identified by previous reports or by scoping searches of full-text databases). In doing so, we equip notified body reviewers to accept the search result by consideration of our methods, rather than number of returned articles (so long as the number returned isn't suspiciously low, given what is known about the device); these methods are generally applied across literature search efforts, regardless of device risk classification.
Article link:
https://www.bsigroup.com/globalassets/meddev/localfiles/en-gb/documents/bsi-md-jmdr-feb-2021-en-gb.pdf------------------------------
Sara VanWyk, MPH, CCRP, RAC, MWC
Principal Regulatory Scientist, RQM+
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Original Message:
Sent: 27-Jan-2022 04:10
From: Anne-Sophie Grell
Subject: Clinical Evaluation, article screening, Class IIa
There is no magic number. It really depends on your product and the amount of articles that you will find with your key words.
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Anne-Sophie Grell
RA lead
Antwerpen
Belgium
Original Message:
Sent: 26-Jan-2022 10:12
From: Anonymous Member
Subject: Clinical Evaluation, article screening, Class IIa
This message was posted by a user wishing to remain anonymous
I am wondering how many articles people are generally reviewing in CERs for Class IIa devices. Thank you!