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 announcement2023. gada 29. novembrisUpdate - Rev 1 - MDCG Position Paper: Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements - November 2023News announcement2023. gada 20. oktobrisCommission Delegated Regulation (EU) 2023/2197 as regards the assignment of Unique Device Identifiers for contact lensesNews announcement2023. gada 18. oktobrisMDCG 2023-4 - Medical Device Software (MDSW) – Hardware combinations Guidance on MDSW intended to work in combination with hardware or hardware components News announcement2023. gada 27. septembrisManual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (September 2023)Skatīt visus Highlights News 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 announcement2022. gada 24. maijsNotice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devicesNews announcement2021. gada 26. maijsNotice 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 announcement2023. gada 29. novembrisUpdate - Rev 1 - MDCG Position Paper: Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements - November 2023
News announcement2023. gada 20. oktobrisCommission Delegated Regulation (EU) 2023/2197 as regards the assignment of Unique Device Identifiers for contact lenses
News announcement2023. gada 18. oktobrisMDCG 2023-4 - Medical Device Software (MDSW) – Hardware combinations Guidance on MDSW intended to work in combination with hardware or hardware components
News announcement2023. gada 27. septembrisManual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (September 2023)
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 announcement2022. gada 24. maijsNotice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices
News announcement2021. gada 26. maijsNotice 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
