ÁttekintésAz EU felülvizsgálta a három irányelvet, hogy a jogi keret tükrözze az elmúlt 20 évben bekövetkezett változásokatFelkészülésManufacturer IVDThe procurement of MDs and IVDsAuthorised Representatives, Importers and DistributorsCompetent authorities in non-EU/EEA countriesÚtmutatókAz Európai Bizottság egy sor útmutató dokumentumot tett közzé, amelyek segítik az érdekelt feleket az orvostechnikai eszközökről szóló rendeletek… Latest updatesNews announcement20 március 2023Regulation (EU) 2023/607 of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisionsNews announcement7 március 2023Commissioner Kyriakides welcomes Council vote on the Medical Device Regulation extensionNews announcement10 február 2023Update - MDCG 2020-16 Rev.2 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 - February 2023News announcement30 november 2022Updated information pack for candidate EU reference laboratories publishedÖsszes megtekintése HighlightsNews announcement5 augusztus 2022Call for EU reference laboratories sent to Member StatesBenchmarks for high-risk diagnosticsNews announcement21 június 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 május 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devicesGeneral publications10 július 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 Events28márc.2023Konferenciák és csúcstalálkozókDay 2: 28 March 2023 IMDRF Stakeholder Forum27márc.2023Konferenciák és csúcstalálkozókDay 1: 27 March 2023 Joint IMDRF / Stakeholder (DITTA-GMTA) Workshop07máj.2021Partneri találkozókWebinar for Patients – Safe and performant Medical Devices for all DocumentsEventsPublications
ÁttekintésAz EU felülvizsgálta a három irányelvet, hogy a jogi keret tükrözze az elmúlt 20 évben bekövetkezett változásokat
FelkészülésManufacturer IVDThe procurement of MDs and IVDsAuthorised Representatives, Importers and DistributorsCompetent authorities in non-EU/EEA countries
ÚtmutatókAz Európai Bizottság egy sor útmutató dokumentumot tett közzé, amelyek segítik az érdekelt feleket az orvostechnikai eszközökről szóló rendeletek…
News announcement20 március 2023Regulation (EU) 2023/607 of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions
News announcement7 március 2023Commissioner Kyriakides welcomes Council vote on the Medical Device Regulation extension
News announcement10 február 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 november 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 május 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devices
General publications10 július 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
27márc.2023Konferenciák és csúcstalálkozókDay 1: 27 March 2023 Joint IMDRF / Stakeholder (DITTA-GMTA) Workshop
