The year 2016 has been a very interesting one from clinical perspective with many developments in the EU medical device regulatory environment, and I am sure we are facing an even more interesting one coming up:
The latest draft of the MDR demands much more robust clinical evidence than before, and is expected to be finalized first half of 2017.
The new version (rev. 4) of the MEDDEV 2.7/1 has serious consequences for existing and new clinical evaluations regardless the class of the device involved.
Given its broad definition of personal data, the new GDPR will affect (retrospective) non-interventional clinical studies, since an informed consent is required regardless the way the health care data are collected.
And last but not least, at a more local level, the Senate of the Dutch parliament approved the proposal to amend the WMO. The amended legislation aims to broaden the possibilities for medical research with minors and incapacitated subjects, and will come into effect in March 2017.
I am looking forward to an exciting year ahead, but for now wish you happy holidays. See you next year.
