The European Council published, on the 22nd February 2017, the final text of the Regulation on medical devices. This text changes and replaces the proposal for a regulation published on the 9th august 2016, which had obtained a political agreement on the 20th...
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...
Nexialist is taking part in the BToHeath Day, come and meet us on the 24th of November 2016 in Marseille at the Intercontinental Hotel. Nexialist is taking part in the BToHealth « The biomedical market within your reach !” day on the 24th November 2016. Do you want to...
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...
ISO 13485 :2016 : Medical Devices – Quality Management System – Regulatory requirements, is available since the 25th of February 2016. This standard should be published in national legislation before September 2016. The working group who has wrote this standard...
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...
The innovation refund plan is a derogative and transitory way to obtain a payment from the French social security, which aims to make easier the access to new technologies and products. It can concern medical devices (MD), in-vitro diagnostic medical device (IVDMD) or...
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...
With the deadline for UDI compliance quickly approaching (Sept 2015 or Sept 2016 according to the FDA extension list), the FDA began accepting GUDID account requests from labelers of implantable, life-supporting, and life-sustaining medical devices on January 26,...
UDI System
Quality
Digital health
Regulation
Electrical devices
PMS / PMCF
Clinical evaluation
Process / Production
Risk management
