PārskatsLai ņemtu vērā pēdējo 20 gadu laikā panākto progresu, ES ir pārskatījusi trīs direktīvas medicīnisko ierīču jomā.SagatavošanāsManufacturer IVDAuthorised Representatives, Importers and DistributorsNorādījumiEiropas Komisija sniedz dažādus ieteikumu dokumentus, lai ieinteresētajām personām palīdzētu īstenot regulas attiecībā uz medicīniskajām ierīcēm.Tie… Latest updatesNews announcement2023. gada 1. decembrisStudy supporting the monitoring of availability of medical devices on the EU market - Surveys for MD and IVD manufacturers and authorised representativesNews announcement2023. gada 27. septembrisManual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (September 2023)News announcement2023. gada 26. septembrisQ&A on transitional provisions for products without an intended medical purpose covered by annex XVI of the MDRNews announcement2023. gada 31. augustsMDR and IVDR Communication SurveySkatīt visus HighlightsNews announcement2022. gada 5. augustsCall for EU reference laboratories sent to Member StatesBenchmarks for high-risk diagnosticsNews announcement2022. gada 21. jūnijsSetting 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 announcement2021. gada 26. maijsNotice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devicesGeneral publications2020. gada 10. jūlijsState 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 Events25-26sept.2023Konferences un samitiIMDRF Meeting 24th session - 25-26 September 2023 - Berlin, Germany28mar.2023Konferences un samitiDay 2: 28 March 2023 IMDRF Stakeholder Forum27mar.2023Konferences un samitiDay 1: 27 March 2023 Joint IMDRF / Stakeholder (DITTA-GMTA) Workshop07mai.2021Partneru sanāksmesWebinar for Patients – Safe and performant Medical Devices for all DocumentsEventsPublications
PārskatsLai ņemtu vērā pēdējo 20 gadu laikā panākto progresu, ES ir pārskatījusi trīs direktīvas medicīnisko ierīču jomā.
NorādījumiEiropas Komisija sniedz dažādus ieteikumu dokumentus, lai ieinteresētajām personām palīdzētu īstenot regulas attiecībā uz medicīniskajām ierīcēm.Tie…
News announcement2023. gada 1. decembrisStudy supporting the monitoring of availability of medical devices on the EU market - Surveys for MD and IVD manufacturers and authorised representatives
News announcement2023. gada 27. septembrisManual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (September 2023)
News announcement2023. gada 26. septembrisQ&A on transitional provisions for products without an intended medical purpose covered by annex XVI of the MDR
News announcement2022. gada 21. jūnijsSetting the scene for EU reference labs for high-risk diagnostics
26 May 2022, the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices is applicable within the EU
News announcement2021. gada 26. maijsNotice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devices
General publications2020. gada 10. jūlijsState 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
25-26sept.2023Konferences un samitiIMDRF Meeting 24th session - 25-26 September 2023 - Berlin, Germany
