ÜlevaadeMeditsiiniseadmetel ja in vitro diagnostika meditsiiniseadmetel on oluline roll elude päästmisel. Need seadmed võimaldavad kasutada uuenduslikke…DirektiividPraegu on ELis kohaldatud järgmisi meditsiiniseadmeid käsitlevaid direktiive: Euroopa Parlamendi ja nõukogu direktiiv 98/79/EÜUued määrusedEL vaatas läbi meditsiiniseadmeid ja in vitro diagnostikat reguleerivad õigusaktid, et viia need vastavusse sektori arenguga viimase 20 aasta jooksul. Latest updates News announcement20 märts 2023Regulation (EU) 2023/607 of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisionsNews announcement10 märts 2023MDCG work in progress - Ongoing guidance documentsNews announcement14 veebruar 2023MDCG 2023-3 - Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices - February 2023News announcement10 veebruar 2023Update - MDCG 2020-16 Rev.2 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 - February 2023Vaadake kõiki Highlights News announcement5 august 2022Call for EU reference laboratories sent to Member StatesBenchmarks 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 announcement24 Mai 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devicesNews announcement26 Mai 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 28märts2023Konverentsid ja tippkohtumisedDay 2: 28 March 2023 IMDRF Stakeholder Forum27märts2023Konverentsid ja tippkohtumisedDay 1: 27 March 2023 Joint IMDRF / Stakeholder (DITTA-GMTA) Workshop07mai2021Kohtumised partneritegaWebinar for Patients – Safe and performant Medical Devices for all Documents EventsPublications
ÜlevaadeMeditsiiniseadmetel ja in vitro diagnostika meditsiiniseadmetel on oluline roll elude päästmisel. Need seadmed võimaldavad kasutada uuenduslikke…
DirektiividPraegu on ELis kohaldatud järgmisi meditsiiniseadmeid käsitlevaid direktiive: Euroopa Parlamendi ja nõukogu direktiiv 98/79/EÜ
Uued määrusedEL vaatas läbi meditsiiniseadmeid ja in vitro diagnostikat reguleerivad õigusaktid, et viia need vastavusse sektori arenguga viimase 20 aasta jooksul.
News announcement20 märts 2023Regulation (EU) 2023/607 of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions
News announcement14 veebruar 2023MDCG 2023-3 - Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices - February 2023
News announcement10 veebruar 2023Update - MDCG 2020-16 Rev.2 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 - February 2023
26 May 2022, the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices is applicable within the EU
News announcement24 Mai 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices
News announcement26 Mai 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
27märts2023Konverentsid ja tippkohtumisedDay 1: 27 March 2023 Joint IMDRF / Stakeholder (DITTA-GMTA) Workshop
