In several EU languages – Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) – infographics
Posts published in January 2019
Medical Devices: The EU will take steps to make use of single audit reports (an initiative of the International Medical Device Regulators Forum – IMDRF) in a…
MDCG 2019-1 MDCG guiding principles for issuing entities rules on Basic UDI-DI
Transition Timelines from the Directives to the Regulations – Medical Devices and in vitro Diagnostic Medical Devices
From the AAMi website – http://www.aami.org/newsviews/newsdetail.aspx?ItemNumber=7367
Reunião do ISO TC 210 JWG 1 em São Paulo – Continuação da revisão da ISO 14971 e ISO TR 24971 – Gerenciamento de risco…
UK published a contingency regulation related to a no deal scenario for Brexit – Contingency legislation covering regulation of medicines and medical devices in a…
Safety and Performance Based Pathway – Guidance for Industry and Food and Drug Administration
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/
Escopo da BSI para o MDR – Regulation (EU) 2017/745 on medical devices http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.pdf&dir_id=34&ntf_id=288798