ARQonDec 18, 20182 minEU Medical Device Regulation (MDR) - Summary of Timeline & 9 PointersBoth the Council Directive 93/42/EEC (MDD) and Council Directive 90/385/EEC (AIMDD) will transition into the Medical Device Regulations...
ARQonDec 18, 20182 minEU In vitro Diagnostic Regulation (IVDR) - Summary of Timeline & 9 PointersThe IVDR is set to replace the IVDD in order to adapt to more technical/scientific requirements for IVDs to be placed in the EU...
ARQonDec 11, 20181 minKey Endorsements in the 7th AMDC MeetingThe AMDTC is working on the following two key work items: Classification of products as Medical Device or Non-Medical Device in the...
ARQonNov 5, 20181 minEurope - Dec 2018EU: UDI guidance documents developed by the MDCG to support implementation of MDR EU: Basic guidance issued for manufacturers on...