PregledMedicinski pripomočki in in vitro diagnostični medicinski pripomočki imajo ključno vlogo pri reševanju življenj, saj zagotavljajo inovativne…DirektiveV EU se trenutno uporabljajo naslednje direktive o medicinskih pripomočkih: Direktiva 98/79/ES Evropskega parlamenta in Sveta ...Novi uredbiEU je revidirala zakone, ki urejajo medicinske pripomočke in in vitro diagnostične pripomočke, da bi jih uskladila z razvojem sektorja v zadnjih 20 letih. Latest updates News announcement28 marec 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 marec 2023Regulation (EU) 2023/607 of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisionsNews announcement10 marec 2023MDCG work in progress - Ongoing guidance documentsNews announcement14 februar 2023MDCG 2023-3 - Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices - February 2023Oglejte si vse Highlights News announcement5 avgust 2022Call for EU reference laboratories sent to Member StatesBenchmarks for high-risk diagnosticsNews announcement21 junij 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 announcement24 maj 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devicesNews announcement26 maj 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devicesThe UDI Helpdesk helps economic operators in the implementation of the requirements introduced by the new systemGetting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities Events 28mar2023Konference in srečanja na vrhuDay 2: 28 March 2023 IMDRF Stakeholder Forum27mar2023Konference in srečanja na vrhuDay 1: 27 March 2023 Joint IMDRF / Stakeholder (DITTA-GMTA) Workshop07maj2021Partnerski sestankiWebinar for Patients – Safe and performant Medical Devices for all Documents EventsPublications
PregledMedicinski pripomočki in in vitro diagnostični medicinski pripomočki imajo ključno vlogo pri reševanju življenj, saj zagotavljajo inovativne…
DirektiveV EU se trenutno uporabljajo naslednje direktive o medicinskih pripomočkih: Direktiva 98/79/ES Evropskega parlamenta in Sveta ...
Novi uredbiEU je revidirala zakone, ki urejajo medicinske pripomočke in in vitro diagnostične pripomočke, da bi jih uskladila z razvojem sektorja v zadnjih 20 letih.
News announcement28 marec 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 marec 2023Regulation (EU) 2023/607 of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions
News announcement14 februar 2023MDCG 2023-3 - Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices - February 2023
26 May 2022, the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices is applicable within the EU
News announcement24 maj 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices
News announcement26 maj 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devices
The UDI Helpdesk helps economic operators in the implementation of the requirements introduced by the new system
Getting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities
27mar2023Konference in srečanja na vrhuDay 1: 27 March 2023 Joint IMDRF / Stakeholder (DITTA-GMTA) Workshop
