The Emergo Group issued a White Paper on 22 October 2012 in regard to the 26 September 2012 Proposed New Medical Device Regulations for Europe (this weblink brings you to the “Medical Devices – Ongoing Revisions” page of the EUROPA website).
The Emergo blog posting says “While the European medical device regulatory system remains largely intact, greater detail has been added, and new mechanisms exist to bolster the weaknesses.” An example, is that in the existing MDD there are only 14 definitions while in the proposed Regulation there are now 50 definitions. As you can see from this example the intent is to clarify the regulation so it is better understood. The Emergo blog post summarizes the high level primary changes while the Emergo White Paper goes into a much deeper analysis.
If you are interested in consulting support from Eisner Safety Consultants to help you through this transition, closer to when finalized, or for current MDD or AIMDD please feel free to contact us via the information at our contact us webpage.