Informacje ogólneAby odzwierciedlić zmiany, jakie nastąpiły w ciągu ostatnich 20 lat, UE dokonała przeglądu ram prawnych, które obejmowały trzy dyrektywy.PrzygotowaniaManufacturer IVDThe procurement of MDs and IVDsAuthorised Representatives, Importers and DistributorsCompetent authorities in non-EU/EEA countriesWytyczneKomisja Europejska udostępnia szereg dokumentów zawierających wytyczne, które mają pomóc zainteresowanym stronom we wdrożeniu rozporządzeń w sprawie… Latest updatesNews announcement28 marzec 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 marzec 2023Regulation (EU) 2023/607 of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisionsNews announcement7 marzec 2023Commissioner Kyriakides welcomes Council vote on the Medical Device Regulation extensionNews announcement10 luty 2023Update - MDCG 2020-16 Rev.2 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 - February 2023Zobacz wszystko HighlightsNews announcement5 sierpień 2022Call for EU reference laboratories sent to Member StatesBenchmarks for high-risk diagnosticsNews announcement21 czerwiec 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 maj 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devicesGeneral publications10 lipiec 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 Events28MAR2023Konferencje i szczytyDay 2: 28 March 2023 IMDRF Stakeholder Forum27MAR2023Konferencje i szczytyDay 1: 27 March 2023 Joint IMDRF / Stakeholder (DITTA-GMTA) Workshop07MAJ2021Spotkania partnerskieWebinar for Patients – Safe and performant Medical Devices for all DocumentsEventsPublications
Informacje ogólneAby odzwierciedlić zmiany, jakie nastąpiły w ciągu ostatnich 20 lat, UE dokonała przeglądu ram prawnych, które obejmowały trzy dyrektywy.
PrzygotowaniaManufacturer IVDThe procurement of MDs and IVDsAuthorised Representatives, Importers and DistributorsCompetent authorities in non-EU/EEA countries
WytyczneKomisja Europejska udostępnia szereg dokumentów zawierających wytyczne, które mają pomóc zainteresowanym stronom we wdrożeniu rozporządzeń w sprawie…
News announcement28 marzec 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 marzec 2023Regulation (EU) 2023/607 of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions
News announcement7 marzec 2023Commissioner Kyriakides welcomes Council vote on the Medical Device Regulation extension
News announcement10 luty 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 maj 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devices
General publications10 lipiec 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
