The next meeting of the MDCG is schedule for 20 June 2019. Some guidance are up for endorsement: Vigilance: Manufacturer Periodic Safety Report (MPSR) form…
Posts tagged as “IVDR”
Commission Implementing Decision (EU) 2019/939 of 6 June 2019 designating issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs)…
EUDAMED UDI Device Data Dictionary MDR – UDI and device data sets to provide in EUDAMED IVDR – UDI and device data sets to provide…
State-of-play of joint assessments of Notified Bodies in the medical device sector
April 2019 update of the MDR and IVDR implementing measures rolling plan
15418/1/18 REV 1 – Corrigendum for the EU IVDR
First guidance on new rules for certain medical devices
In several EU languages – Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) – infographics
Transition Timelines from the Directives to the Regulations – Medical Devices and in vitro Diagnostic Medical Devices
Processo de designação para o IVDR – Regulation (EU) 2017/746 dos membros do Team-NB http://www.team-nb.org/team-nb-publishes-a-press-release-regarding-the-designation-process-in-the-framework-of-the-ivdr-regulation/