EU MEDICAL DEVICE CLINICAL EVIDENCE 2016/2017

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.

acs_kaart_2015-3-002

Advertisements

About Annet Muetstege

My name is Annet Muetstege and I am a clinical research expert, based in The Netherlands, with over 25 years of experience in all aspects of clinical evidence planning and execution especially in medical devices. I am the co-founder of Applied Clinical Services.
This entry was posted in Uncategorized and tagged , , , , , , , , , , , , . Bookmark the permalink.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s