Open letter to the European Commission on the implementation and readiness status of the new Medical Device Regulation (MDR)
Posts published in “Medical Device Regulation MDR”
MDCG 2019-3 Interpretation of Article 54(2)b
15409/1/18 REV 1 – Corrigendum for the EU MDR
Draft Functional specifications for the European Database on Medical Devices (Eudamed) – First release (High(1)) to be audited
Consultation: Proposed changes to the classification of medical devices used in direct contact with the heart, central circulatory or central nervous systems Consultation: Proposed new…
First guidance on new rules for certain medical devices
MDCG 2018-8 – Guidance on Content of the certificates, voluntary certificate transfers
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
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