PanoramicaI dispositivi medici e i dispositivi medico-diagnostici in vitro rivestono un ruolo fondamentale nel salvare vite, poiché forniscono soluzioni…Direttive vigentiAttualmente nell'UE si applicano le seguenti direttive sui dispositivi medici:1998: direttiva 98/79/CE del Parlamento europeo e del Consiglio…Nuovi regolamentiL'UE ha modificato le norme che disciplinano i dispositivi medici e i dispositivi medico-diagnostici in vitro per adeguarle agli sviluppi del settore negli ultimi vent'anni. I... Ultimi aggiornamenti News announcement20 marzo 2023Regulation (EU) 2023/607 of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisionsNews announcement10 marzo 2023MDCG work in progress - Ongoing guidance documentsNews announcement14 febbraio 2023MDCG 2023-3 - Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices - February 2023News announcement10 febbraio 2023Update - MDCG 2020-16 Rev.2 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 - February 2023Mostra tutto Highlights News announcement5 agosto 2022Call for EU reference laboratories sent to Member StatesBenchmarks for high-risk diagnosticsNews announcement21 giugno 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 maggio 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devicesNews announcement26 maggio 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 Eventi 28mar2023Conferenze e verticiDay 2: 28 March 2023 IMDRF Stakeholder Forum27mar2023Conferenze e verticiDay 1: 27 March 2023 Joint IMDRF / Stakeholder (DITTA-GMTA) Workshop07mag2021Riunioni dei partnerWebinar for Patients – Safe and performant Medical Devices for all Documenti EventsPublications
PanoramicaI dispositivi medici e i dispositivi medico-diagnostici in vitro rivestono un ruolo fondamentale nel salvare vite, poiché forniscono soluzioni…
Direttive vigentiAttualmente nell'UE si applicano le seguenti direttive sui dispositivi medici:1998: direttiva 98/79/CE del Parlamento europeo e del Consiglio…
Nuovi regolamentiL'UE ha modificato le norme che disciplinano i dispositivi medici e i dispositivi medico-diagnostici in vitro per adeguarle agli sviluppi del settore negli ultimi vent'anni. I...
News announcement20 marzo 2023Regulation (EU) 2023/607 of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions
News announcement14 febbraio 2023MDCG 2023-3 - Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices - February 2023
News announcement10 febbraio 2023Update - MDCG 2020-16 Rev.2 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 - February 2023
26 May 2022, the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices is applicable within the EU
News announcement24 maggio 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices
News announcement26 maggio 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
