PārskatsMedicīniskajām ierīcēm un invitro diagnostikas medicīniskajām ierīcēm ir būtiska nozīme dzīvību glābšanā, jo tās piedāvā novatoriskus veselības…Spēkā esošās direktīvasEiropas Savienībā patlaban ir piemērojamas šādas medicīnisko ierīču direktīvas:1998: Eiropas Parlamenta un Padomes Direktīva98/79/EK par…Jaunas regulasES ir pārskatījusi tiesību aktus, kas reglamentē medicīniskās ierīces un in vitro diagnostiku, ar nolūku pielāgot tos nozares attīstībai pēdējo 20 gadu laikā ... Latest updates News announcement12 maijs 2023UPDATE - MDCG 2020-3 Rev.1 - Guidance on significant changes regarding the transitional provision under Article 120 of the MDR - May 2023News announcement8 maijs 20232023/C 163/06 - Commission Guidance on the content and structure of the summary of the clinical investigation report - May 2023News announcement21 aprīlis 2023Meeting audio available - Day 1 & 2: 27-28 March 2023 IMDRF Stakeholder ForumNews announcement21 aprīlis 2023IMDRF Meeting 24th session - 25-26 September 2023 - Berlin, GermanySkatīt visus Highlights News announcement5 augusts 2022Call for EU reference laboratories sent to Member StatesBenchmarks for high-risk diagnosticsNews announcement21 jūnijs 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 maijs 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devicesNews announcement26 maijs 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 25-26sept.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 Documents EventsPublications
PārskatsMedicīniskajām ierīcēm un invitro diagnostikas medicīniskajām ierīcēm ir būtiska nozīme dzīvību glābšanā, jo tās piedāvā novatoriskus veselības…
Spēkā esošās direktīvasEiropas Savienībā patlaban ir piemērojamas šādas medicīnisko ierīču direktīvas:1998: Eiropas Parlamenta un Padomes Direktīva98/79/EK par…
Jaunas regulasES ir pārskatījusi tiesību aktus, kas reglamentē medicīniskās ierīces un in vitro diagnostiku, ar nolūku pielāgot tos nozares attīstībai pēdējo 20 gadu laikā ...
News announcement12 maijs 2023UPDATE - MDCG 2020-3 Rev.1 - Guidance on significant changes regarding the transitional provision under Article 120 of the MDR - May 2023
News announcement8 maijs 20232023/C 163/06 - Commission Guidance on the content and structure of the summary of the clinical investigation report - May 2023
News announcement21 aprīlis 2023Meeting audio available - Day 1 & 2: 27-28 March 2023 IMDRF Stakeholder Forum
26 May 2022, the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices is applicable within the EU
News announcement24 maijs 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices
News announcement26 maijs 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
25-26sept.2023Konferences un samitiIMDRF Meeting 24th session - 25-26 September 2023 - Berlin, Germany
