Ülevaade Suunistes on esitatud teave ja lingid teemade kohta, mis on olulised meditsiiniseadmeid käsitleva määruse rakendamiseks. Suunised ... Teavitatud asutused Teavitatud asutus on ELi liikmesriigi (või erilepingu alusel teise riigi) määratud organisatsioon, kes hindab teatavate toodete vastavust... Seadme kordumatu identifitseerimistunnus (UDI) Seadme kordumatu identifitseerimistunnus (UDI) on meditsiiniseadme kordumatu numbriline või tähtnumbriline kood. See võimaldab konkreetsete turul… TaastöötlemineHealth institutions reprocessing single-use devicesNational rules on reprocessing of single-use devicesHarmoneeritud standardid Meditsiiniseadmeid käsitlevate määruste kohaselt töötavad harmoneeritud Euroopa standardid välja Euroopa Standardikomitee ja Euroopa Elektrotehnika Standardikomitee kui Euroopa standardiorganisatsioonid. Latest updatesNews announcement17 Mai 2022New publication of Harmonised standards under the medical devices RegulationsNews announcement23 märts 2022Update - Short overview of the information on the applications for designation as a notified bodyNews announcement4 oktoober 2021The EUDAMED UDI/Devices and NBs & Certificates modules are open. Economic Operators and Notified Bodies can start entering data in EUDAMED on voluntary basisNews announcement3 september 2021The expert panel in the field of in vitro diagnostic medical devices now accepts submissions from notified bodies for the Performance Evaluation Consultation ProcedureVaadake kõiki MD Topics of Interest - HighlightsThe 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 activitiesCommission Notice on notified bodies’ audits performed during Covid-19 exceptional circumstancesGeneral publications12 juuli 2020Commission guidelines on Union-wide derogations for medical devicesGeneral publications26 juuni 2020List of COVID-19 essential Medical Devices (MDs and IVDs) DocumentsPublications
News announcement17 Mai 2022New publication of Harmonised standards under the medical devices Regulations
News announcement23 märts 2022Update - Short overview of the information on the applications for designation as a notified body
News announcement4 oktoober 2021The EUDAMED UDI/Devices and NBs & Certificates modules are open. Economic Operators and Notified Bodies can start entering data in EUDAMED on voluntary basis
News announcement3 september 2021The expert panel in the field of in vitro diagnostic medical devices now accepts submissions from notified bodies for the Performance Evaluation Consultation Procedure
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
