In March 2014 Gert Bos (Head of Regulatory and Clinical Affairs at notified body BSI) and I wrote a white paper on the new EU medical devices and IVD regulations in the legislative procedure. It was well received and as the legislative procedure for the regulations progressed there has been an increasing demand for update of the white paper.
Updated white paper
That update is now available and you can download it from here. The updated white paper reflects the situation as per the start of the trilogue beginning of October this year (5 October EPSCO meeting), so it takes the last publicly available Council proposed text into account. Like the previous version we hope that it will be of use for everyone!
medicaldeviceslegal 
I often read these kinds of documents by printing them out and taking them with me. I might not always read them from beginning to end in one sitting, but perhaps, read a few pages while waiting for an appointment or meeting.
There has been a tendency lately for many similar publications to use a small font size and grey colored type face. This makes it very difficult for people, such as me, whose eyes are getting older. Would it be possible to republish this article, and change the strategy for the future, to a larger black font? Since these are not pionted and distributed, the page count should not affect the production cost.