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 announcement31 de agosto de 2023MDR and IVDR Communication SurveyNews announcement23 de agosto de 2023Flowchart to assist in deciding whether or not a device is covered by the extended MDR transitional periodNews announcement18 de julio de 2023Rev. 1 - Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607News announcement30 de junio de 2023Add 1 - MDCG Position Paper on the application of Art.97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificateVer todo Reflejos News announcement5 de agosto de 2022Call for EU reference laboratories sent to Member StatesBenchmarks for high-risk diagnosticsNews announcement21 de junio de 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 de mayo de 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devicesNews announcement26 de mayo de 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 25-26sep2023Conferencias y cumbresIMDRF Meeting 24th session - 25-26 September 2023 - Berlin, Germany28mar2023Conferencias y cumbresDay 2: 28 March 2023 IMDRF Stakeholder Forum27mar2023Conferencias y cumbresDay 1: 27 March 2023 Joint IMDRF / Stakeholder (DITTA-GMTA) Workshop07may2021Reuniones 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 announcement23 de agosto de 2023Flowchart to assist in deciding whether or not a device is covered by the extended MDR transitional period
News announcement18 de julio de 2023Rev. 1 - Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607
News announcement30 de junio de 2023Add 1 - MDCG Position Paper on the application of Art.97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate
News announcement21 de junio de 2022Setting the scene for EU reference labs for high-risk diagnostics
26 May 2022, the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices is applicable within the EU
News announcement24 de mayo de 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices
News announcement26 de mayo de 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
25-26sep2023Conferencias y cumbresIMDRF Meeting 24th session - 25-26 September 2023 - Berlin, Germany
