In November 2017 the 2016 edition of EN ISO 13485 was harmonized edition under the European Directives 93/42/EEC on medical devices and 98/79/EC in vitro diagnostic medical devices. Therefore this...
The current version of the guidance document MEDDEV 2.7/1 was published as Revision 4 on the website of the European Commission end of June 2016. This document includes the methodology to conduct a...
After negotiations that extended over years, the new regulations for medical devices (Medical Device Regulation, MDR) and in-vitro diagnostic medical devices (In-Vitro Diagnostic Medical Devices...
In March 2016 the new revision of ISO 13485 was published. In contrary to ISO 9001:2015 the ISO 13485:2016 does not follow the ISO high level structure. In addition no reduction of requirements was...
After the publication of ANSM now Swissmedic published a procedure in order to give manufacturers located in Switzerland, whose Notified Body terminated his activities due to de-notification or other...
According to an information sheet and a list of questions and answers issued by the French Competent Authority ANSM there is a possibility for manufacturers, whose Notified Body terminated his...
Publication of the german Federal Ministry of Health (2016-06-15) and special rule of the Land authorities responsible for medical devices and the Central Authority (2016-06-24)
