ARQonJun 121 minFrance: ANSM Designates AFNOR as the Newest Notified BodyMedical devices to be marketed in the European market must obtain CE Marking as proof the devices meet the highest safety, health, and...
ARQonJul 30, 20201 minEurope - May 2020Denmark: New rules mean non-serious adverse events may also need to be reported EU: Application of Regulation (EU) 2017/745 postponed by...
ARQonJun 30, 20201 minEU: MDR delayed to 26 May 2021 Application of the Medical Devices Regulation (MDR) has been deferred by one year, until 26 May 2021, for fear of shortage or delay in...
ARQonJan 31, 20201 minEU 2020 MDR Guidance Notes For Class I ManufacturersThere will be no transition period for Class I medical devices which remain in Class I under MDR. From 26th May 2020 onwards, the...