New version, Version 1.21 (01-2019) – MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES
Posts published in “European Commission”
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/
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
Primeiro NB designado para o MDR – BSi UK http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34
Interesting read from BSI – Want to know more about the Notified Body?
Interesting read from BSI – MDR Documentation Submissions Best Practices Guidelines
MDR and IVDR implementing measures rolling plan – December 2018
Guide for referencing standards in public procurement in Europe (JIS Action 11)