Clinical Evaluation MEDDEV Guidelines SmackDown - 2017

Sam Lazzara

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I have prepared a side-by-side comparison between MEDDEV 2.7/1 Rev. 4 (2016) and MEDDEV 2.7.1 Rev. 3 (2009) guidelines. An MS Word version is attached. Nothing magical about what I did - very boring though....

This could be an important first step to help folks update their Clinical Evaluation SOP (or write one for the first time) and/or update their "old" clinical evaluation reports.

Please let me know if there are improvements that can be made.



  • Europe Clinical Evaluation MEDDEV 2.7_1 Rev 4 vs MEDDEV 2.7.1 Rev 3__Sam Lazzara.docx
    1.6 MB · Views: 409

Edward Reesor

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Thanks Sam!
I made a similar document for our new technical file template and added the contents of the right hand column as a comparator for when I perform the review of our technical files. I find that as I go through each review, having reference to the previous version is very helpful.


Most appreciated. Minor typo on every page: MEDDEV 2.7/1 Rev 4 (2009) versus MEDDEV 2.7.1 Rev 3 (2016) should be MEDDEV 2.7/1 Rev 4 (2016) versus MEDDEV 2.7.1 Rev 3 (2009)
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