Ülevaade EL on vaadanud läbi kolme direktiivi õigusraamistiku, et võtta arvesse viimase 20 aasta jooksul toimunud arenguid. ValmistumineManufacturer IVDManufacturers MDManufacturers of devices without an intended medical purposeHealthcare professionals and health institutionsThe procurement of MDs and IVDsAuthorised Representatives, Importers and DistributorsCompetent authorities in non-EU/EEA countriesSuunised Euroopa Komisjon esitab mitmesugused juhenddokumendid, et aidata sidusrühmadel rakendada meditsiiniseadmeid käsitlevaid õigusakte.Tegemist on… Latest updatesNews announcement5 juuli 2022Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications in accordance with Regulation (EU) 2017/746News announcement21 juuni 2022Setting the scene for EU reference labs for high-risk diagnosticsNews announcement24 Mai 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devicesNews announcement13 aprill 2022Notice to Stakeholders: EU-Turkey Customs Union Agreement in the field of medical devicesVaadake kõiki HighlightsBenchmarks for high-risk diagnosticsNews announcement21 juuni 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 Mai 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devicesGeneral publications10 juuli 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 activitiesCommission Notice on notified bodies’ audits performed during Covid-19 exceptional circumstances Events07mai2021 Kohtumised partneritega Webinar for Patients – Safe and performant Medical Devices for all DocumentsEventsPublications
News announcement5 juuli 2022Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications in accordance with Regulation (EU) 2017/746
News announcement24 Mai 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices
News announcement13 aprill 2022Notice to Stakeholders: EU-Turkey Customs Union Agreement in the field of medical devices
26 May 2022, the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices is applicable within the EU
News announcement26 Mai 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devices
General publications10 juuli 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
