PanorâmicaA UE reviu o quadro jurídico das 3 diretivas para refletir os progressos realizados nos últimos 20 anos.Preparar-seManufacturer IVDThe procurement of MDs and IVDsAuthorised Representatives, Importers and DistributorsCompetent authorities in non-EU/EEA countriesOrientaçõesA Comissão Europeia fornece uma série de documentos de orientação para ajudar as partes interessadas na aplicação dos regulamentos relativos aos… Latest updatesNews announcement20 março 2023Regulation (EU) 2023/607 of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisionsNews announcement7 março 2023Commissioner Kyriakides welcomes Council vote on the Medical Device Regulation extensionNews announcement10 fevereiro 2023Update - MDCG 2020-16 Rev.2 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 - February 2023News announcement30 novembro 2022Updated information pack for candidate EU reference laboratories publishedVer tudo HighlightsNews 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 announcement26 maio 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devicesGeneral publications10 julho 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 Events28mar2023Conferências 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 DocumentsEventsPublications
PanorâmicaA UE reviu o quadro jurídico das 3 diretivas para refletir os progressos realizados nos últimos 20 anos.
Preparar-seManufacturer IVDThe procurement of MDs and IVDsAuthorised Representatives, Importers and DistributorsCompetent authorities in non-EU/EEA countries
OrientaçõesA Comissão Europeia fornece uma série de documentos de orientação para ajudar as partes interessadas na aplicação dos regulamentos relativos aos…
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 announcement7 março 2023Commissioner Kyriakides welcomes Council vote on the Medical Device Regulation extension
News announcement10 fevereiro 2023Update - MDCG 2020-16 Rev.2 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 - February 2023
News announcement30 novembro 2022Updated information pack for candidate EU reference laboratories published
26 May 2022, the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices is applicable within the EU
News announcement26 maio 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devices
General publications10 julho 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
