News, opinions and insights about medical device regulations and standards

Notícias, opiniões e insights sobre regulamentos e normas de dispositivos médicos

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Category: In Vitro Diagnostic Medical Device Regulation

Corrigendum for the EU IVDR Published

19 Mar, 2019 Marcelo Antunes In Vitro Diagnostic Medical Device Regulation

15418/1/18 REV 1 – Corrigendum for the EU IVDR

EU – Draft Functional specifications for the European Database on Medical Devices (Eudamed) – First release (High(1)) to be audited

6 Mar, 2019 Marcelo Antunes European Commission, In Vitro Diagnostic Medical Device Regulation, Medical Device Regulation MDR, Uncategorized

Draft Functional specifications for the European Database on Medical Devices (Eudamed) – First release (High(1)) to be audited

EMA – Guidelines for certain medical devices incorporating medicinal products – Orientações para certos medical devices que incorporam medicamentos

28 Feb, 2019 Marcelo Antunes European Medicines Agency - EMA, In Vitro Diagnostic Medical Device Regulation, Medical Device Regulation MDR

First guidance on new rules for certain medical devices

EU – MDCG 2018-8 – Guidance on Content of the certificates, voluntary certificate transfers

18 Feb, 2019 Marcelo Antunes Europe, In Vitro Diagnostic Medical Device Regulation, Medical Device Regulation MDR

MDCG 2018-8 – Guidance on Content of the certificates, voluntary certificate transfers

EU – Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) – infographics

31 Jan, 2019 Marcelo Antunes In Vitro Diagnostic Medical Device Regulation, Medical Device Regulation MDR

In several EU languages – Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) – infographics

EU – Transition Timelines from the Directives to the Regulations – Medical Devices and in vitro Diagnostic Medical Devices

29 Jan, 2019 Marcelo Antunes In Vitro Diagnostic Medical Device Regulation, Medical Device Regulation MDR

Transition Timelines from the Directives to the Regulations – Medical Devices and in vitro Diagnostic Medical Devices

Last update of the MDR and IVDR implementing measures rolling plan – December 2018

14 Jan, 2019 Marcelo Antunes Europe, In Vitro Diagnostic Medical Device Regulation, Medical Device Regulation MDR

MDR and IVDR implementing measures rolling plan – December 2018

Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) and Incidents (MDD/IMDD/IVDD)

19 Dec, 2018 Marcelo Antunes Active Implantable Medical Devices Directive, In Vitro Diagnostic Medical Device Regulation, In Vitro Diagnostic Medical Devices Directive, Medical Device Regulation MDR, Medical Devices Directive

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 Incidents (MDR/IVDR) and Incidents (MDD/IMDD/IVDD) New Manufacturer Incident Report helptext.