The European Commission started to develop new medical device regulations after the last amendment of the MDD and AIMD were formally published. As a result of several adverse event with medical devices that were extensively reported on in the media and has had impact on many patients, the scope of the development of the new regulations was enlarged.
In 2012 the first proposal text was published and since then was scrutinized by the European Parliament and the European Council. After a long political process, in June 2016 a concensus text was published, ready for translation.
In this presentation, the main new or revised elements in the upcoming EU Regulation for medical devices will be highlighted, taking into account that the final text is still to be published. Also the challenges for industry, Notified Bodies and Competent Authorities will be presented.