PanorâmicaOs dispositivos médicos e os dispositivos médicos para diagnóstico in vitro (DIV) desempenham um papel fundamental na hora de salvar vidas,…DiretivasAs seguintes diretivas relativas aos dispositivos médicos são atualmente aplicáveis na UE1998: Diretiva 98/79/CE do Parlamento Europeu e do Conselho …Novos regulamentosA UE reviu a legislação que rege os dispositivos médicos e os dispositivos médicos para diagnóstico in vitro, a fim de acompanhar a evolução do setor nos últimos 20 anos. A... Ultimas atualizações News announcement28 março 2023Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 - Extension of the MDR transitional period and removal of the “sell off” periodsNews announcement20 março 2023Regulation (EU) 2023/607 of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisionsNews announcement10 março 2023MDCG work in progress - Ongoing guidance documentsNews announcement14 fevereiro 2023MDCG 2023-3 - Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices - February 2023Ver tudo Destaques News announcement5 agosto 2022Call for EU reference laboratories sent to Member StatesBenchmarks for high-risk diagnosticsNews announcement21 junho 2022Setting the scene for EU reference labs for high-risk diagnostics26 May 2022, the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices is applicable within the EUNews announcement24 maio 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devicesNews announcement26 maio 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devicesThe UDI Helpdesk helps economic operators in the implementation of the requirements introduced by the new systemGetting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities Eventos 28mar2023Conferências e cimeirasDay 2: 28 March 2023 IMDRF Stakeholder Forum27mar2023Conferências e cimeirasDay 1: 27 March 2023 Joint IMDRF / Stakeholder (DITTA-GMTA) Workshop07mai2021Reuniões de parceirosWebinar for Patients – Safe and performant Medical Devices for all Documentos EventsPublications
PanorâmicaOs dispositivos médicos e os dispositivos médicos para diagnóstico in vitro (DIV) desempenham um papel fundamental na hora de salvar vidas,…
DiretivasAs seguintes diretivas relativas aos dispositivos médicos são atualmente aplicáveis na UE1998: Diretiva 98/79/CE do Parlamento Europeu e do Conselho …
Novos regulamentosA UE reviu a legislação que rege os dispositivos médicos e os dispositivos médicos para diagnóstico in vitro, a fim de acompanhar a evolução do setor nos últimos 20 anos. A...
News announcement28 março 2023Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 - Extension of the MDR transitional period and removal of the “sell off” periods
News announcement20 março 2023Regulation (EU) 2023/607 of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions
News announcement14 fevereiro 2023MDCG 2023-3 - Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices - February 2023
26 May 2022, the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices is applicable within the EU
News announcement24 maio 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices
News announcement26 maio 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devices
The UDI Helpdesk helps economic operators in the implementation of the requirements introduced by the new system
Getting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities
