The European Commission’s medical device conniption reached a frenzied pitch with the release of the Medical Devices Regulation (MDR) 745/2017 in May 2017.
Credit: Google (hyperlink)
The writing has been on the wall for awhile now. The Europe Clinical Evaluation guidelines were updated from Rev. 3 (2009) to Rev. 4 in 2016. The new guidelines – MEDDEV 2.7/1 Rev. 4 – foreshadowed the requirements of the European MDR.
To help with your own personal conniption and subsequent preparations, I have prepared a side-by-side comparison between the Rev. 4 and Rev. 3 documents. Here it is in MS Word format so you can use it for your own purposes.
May the clinical evaluation judges be kind (or at least fair) to you!