Panorama generalLos productos sanitarios y los productos sanitarios para diagnóstico in vitro desempeñan un papel fundamental a la hora de salvar vidas, gracias a la…Directivas en vigorLas siguientes Directivas sobre productos sanitarios son aplicables en la actualidad dentro de la Unión:1998: Directiva 98/79/CE del Parlamento…Nuevos ReglamentosLa UE revisó los Reglamentos que regulan los productos sanitarios y los productos sanitarios para diagnóstico in vitro a fin de adecuarlos a la evolución del sector durante los últimos veinte años. Últimas actualizaciones News announcement12 enero 2023MDCG 2023-2 - List of Standard Fees - January 2023News announcement10 enero 2023MDCG 2023-1 - Guidance on the health institution exception under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 - January 2023News announcement16 diciembre 2022MDCG 2022-21 - Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 - December 2022News announcement16 diciembre 2022MDCG 2022-4 rev.1 - Guidance on appropriate surveillance regarding MDR Art.120 transitional provisions - devices covered by MDD or AIMDD certificates - December 2022Ver todo Reflejos News announcement5 agosto 2022Call for EU reference laboratories sent to Member StatesBenchmarks for high-risk diagnosticsNews announcement21 junio 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 mayo 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devicesNews announcement26 mayo 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 07may2021Reuniones de sociosWebinar for Patients – Safe and performant Medical Devices for all Documentos EventsPublications
Panorama generalLos productos sanitarios y los productos sanitarios para diagnóstico in vitro desempeñan un papel fundamental a la hora de salvar vidas, gracias a la…
Directivas en vigorLas siguientes Directivas sobre productos sanitarios son aplicables en la actualidad dentro de la Unión:1998: Directiva 98/79/CE del Parlamento…
Nuevos ReglamentosLa UE revisó los Reglamentos que regulan los productos sanitarios y los productos sanitarios para diagnóstico in vitro a fin de adecuarlos a la evolución del sector durante los últimos veinte años.
News announcement10 enero 2023MDCG 2023-1 - Guidance on the health institution exception under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 - January 2023
News announcement16 diciembre 2022MDCG 2022-21 - Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 - December 2022
News announcement16 diciembre 2022MDCG 2022-4 rev.1 - Guidance on appropriate surveillance regarding MDR Art.120 transitional provisions - devices covered by MDD or AIMDD certificates - December 2022
26 May 2022, the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices is applicable within the EU
News announcement24 mayo 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices
News announcement26 mayo 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
