The Four Most Common Reasons for Non-Conformities in Clinical Evaluations

The new MEDEV directive detailing the required contents of Clinical Evaluations has been out for several years now but there still seems to be some confusion about how to implement it.
As a freelance medical writer/regulatory consultant I have written more than 50 Clinical Evaluations over the past 5 years. In addition I have revised Clinical Evaluations that clients have written themselves, submitted to a notified body and received non-conformities. I’d like to share with you the 4 top reasons that I have seen for these non-conformities:
1) Failure to describe article search procedure – You must include your search strings, where you searched and how many hits you got for each search.
2) Unqualified person wrote the document – I have seen Clinical Evaluations where the director of marketing wrote the document. I’m sure that he/she is a very good director of marketing but in most cases that does not make them qualified to provide an analysis of the scientific literature and other required content.
3) Failure to grade the articles evaluated – You must explain your grading system and use it to justify inclusion/exclusion of articles.
4) Including only a literature review – A Clinical Evaluation is much more than just a literature review. Depending on where you device is in its life cycle, you may also need to include information such as post-marketing data, bench tests, unpublished clinical studies and comparisons with similar devices.
Some of you reading the above may be thinking: “we submitted a Clinical Evaluation with some or all of these defects and no non-conformities were generated”. This can definitely be the case because there is still a certain amount of inconsistencies between notified bodies and within the notified bodies themselves as to how Clinical Evaluations are to be reviewed. However, I can definitely say that over the past several years notified bodies have become much more strict in their reviews of Clinical Evaluations.


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