Annulment of Decree No. 2016-1716 that was published in the Official Journal of the French Republic on December 13th 2016 05/02/2018 Decree n°2016-1716, regarding the « medical device characteristics summary » was annuled by the French Council of State on april, 26th...
Since the 14th April 2016, the European Parliment has adopted the (EU) n°2016/679 Regulation The Regulation (EU) 2016/679 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data was adopted by The...
New version of the list of regulatory positions and classifications of MDs and IVDs On January 22, 2016, the ANSM published a new version of the “FAQ” on regulatory positions and classifications of medical devices and in vitro diagnostic medical devices (dated...
On the 2nd of October 2015, IMDRF published 5 information documents describing the application of some standards regarding medical devices in the countries, or group of countries, which are members of the IMDRF: Australia, Brazil, Canada, China, Europe, Japan, Russia...
The FDA published « Refuse to Accept Policy for 510(k)s » in August 2015, a new guidance document for medical device manufacturers. It aims at helping manufacturers of class II MD (mainly), to properly prepare and submit their 510(k) submissions to get approval in the...
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