Visión generalLa UE ha revisado el marco jurídico de tres directivas para reflejar los avances que se han producido en los últimos veinte años.PreparaciónManufacturer IVDThe procurement of MDs and IVDsAuthorised Representatives, Importers and DistributorsCompetent authorities in non-EU/EEA countriesOrientacionesLa Comisión Europea ofrece una serie de documentos de orientación para ayudar a las partes interesadas a aplicar la normativa sobre productos… Latest updatesNews announcement28 marzo 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 marzo 2023Regulation (EU) 2023/607 of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisionsNews announcement7 marzo 2023Commissioner Kyriakides welcomes Council vote on the Medical Device Regulation extensionNews announcement10 febrero 2023Update - MDCG 2020-16 Rev.2 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 - February 2023Ver todo HighlightsNews 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 announcement26 mayo 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devicesGeneral publications10 julio 2020State of play of Joint implementation Plan on actions considered necessary to ensure the sound functioning of the new framework for medical devices under the MDRThe UDI Helpdesk is live. It helps the economic operators in the implementation of the requirements introduced by the new UDI systemGetting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities Events28mar2023Conferencias 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 DocumentsEventsPublications
Visión generalLa UE ha revisado el marco jurídico de tres directivas para reflejar los avances que se han producido en los últimos veinte años.
PreparaciónManufacturer IVDThe procurement of MDs and IVDsAuthorised Representatives, Importers and DistributorsCompetent authorities in non-EU/EEA countries
OrientacionesLa Comisión Europea ofrece una serie de documentos de orientación para ayudar a las partes interesadas a aplicar la normativa sobre productos…
News announcement28 marzo 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 marzo 2023Regulation (EU) 2023/607 of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions
News announcement7 marzo 2023Commissioner Kyriakides welcomes Council vote on the Medical Device Regulation extension
News announcement10 febrero 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 announcement26 mayo 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devices
General publications10 julio 2020State of play of Joint implementation Plan on actions considered necessary to ensure the sound functioning of the new framework for medical devices under the MDR
The UDI Helpdesk is live. It helps the economic operators in the implementation of the requirements introduced by the new UDI system
Getting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities
