Addressing of Undesirable side-effects, harms, risks and side-effects in clinical evaluation report (CER)

[FoGia]

This is a good point that side effects and ADEs could be different with respect to adverse patient reaction related to device malfunction, although wihtout a formal definition of side effects this seems to be a matter of opinion.
I didn't understand the definition of ADE as consisting of only device problems, so I googled it but found no source having that same interpretation, ADEs for me are broader than AE following device problems. For instance http://firstclinical.com/journal/2009/0912_ISO_14155.pdf makes no such limitation.

 

[Marcelo]

You are right, I was just revising the last draft of ISO 14155 and it just keep the original table on classification, so ADEs do include any output not related to malfunctions.

Anyway, the other part of the comment still stands. You can see it in 4.6 here: http://www.imdrf.org/docs/ghtf/fina...-sg2-n54r8-guidance-adverse-events-061130.pdf.

Related to a definition, although I don't remember seeing a definition in medical device regulations, the concept comes from medicine and drugs. In this case, you can find some definitions:

Broken link deleted.

There is a comment here: https://www.ich.org/fileadmin/Publi...idelines/Efficacy/E2A/Step4/E2A_Guideline.pdf and here https://www.fda.gov/downloads/drugs/guidances/ucm073087.pdf the says:

1. The old term "side effect" has been used in various ways in the past, usually to describe negative (unfavorable) effects, but also positive (favorable) effects. It is recommended that this term no longer be used and particularly should not be regarded as synonymous with adverse event or adverse reaction.

Which is probably the reason we do not have a definition of side effect.

 

[FoGia]

Thanks Marcelo, it's a pity that the MDR uses terminology that is considered obsolete... (the word appears 13 times in the MDR).