PanorâmicaA UE reviu o quadro jurídico das 3 diretivas para refletir os progressos realizados nos últimos 20 anos.Preparar-seManufacturer IVDAuthorised Representatives, Importers and DistributorsOrientaçõesA Comissão Europeia fornece uma série de documentos de orientação para ajudar as partes interessadas na aplicação dos regulamentos relativos aos… Latest updatesNews announcement1 de dezembro de 2023Study supporting the monitoring of availability of medical devices on the EU market - Surveys for MD and IVD manufacturers and authorised representativesNews announcement27 de setembro de 2023Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (September 2023)News announcement26 de setembro de 2023Q&A on transitional provisions for products without an intended medical purpose covered by annex XVI of the MDRNews announcement31 de agosto de 2023MDR and IVDR Communication SurveyVer tudo HighlightsNews announcement5 de agosto de 2022Call for EU reference laboratories sent to Member StatesBenchmarks for high-risk diagnosticsNews announcement21 de junho 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 announcement26 de maio de 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devicesGeneral publications10 de julho de 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 Events25-26set2023Conferências e cimeirasIMDRF Meeting 24th session - 25-26 September 2023 - Berlin, Germany28mar2023Conferências 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.
OrientaçõesA Comissão Europeia fornece uma série de documentos de orientação para ajudar as partes interessadas na aplicação dos regulamentos relativos aos…
News announcement1 de dezembro de 2023Study supporting the monitoring of availability of medical devices on the EU market - Surveys for MD and IVD manufacturers and authorised representatives
News announcement27 de setembro de 2023Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (September 2023)
News announcement26 de setembro de 2023Q&A on transitional provisions for products without an intended medical purpose covered by annex XVI of the MDR
News announcement21 de junho 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 announcement26 de maio de 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devices
General publications10 de julho de 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
25-26set2023Conferências e cimeirasIMDRF Meeting 24th session - 25-26 September 2023 - Berlin, Germany
