MDCG 2019-3 Interpretation of Article 54(2)b
Posts tagged as “MDR”
15409/1/18 REV 1 – Corrigendum for the EU MDR
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
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
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 – MDR Documentation Submissions Best Practices Guidelines
MDR and IVDR implementing measures rolling plan – December 2018
Manufacturers with CE Marking shall update their procedures and forms. Fabricantes com Marcação CE devem atualizar seus procedimentos e formulários. Manufacturer Incident Report (MIR) for Serious…