Pregled Medicinski proizvodi i in vitro dijagnostički medicinski proizvodi igraju glavnu ulogu u spašavanju života tako što pružaju inovativna zdravstvena… Postojeće direktive U EU-u se trenutačno primjenjuju sljedeće direktive o medicinskim proizvodima1998.: Direktiva 98/79/EZ Europskog parlamenta i Vijeća o in vitro… Novi propisi EU je revidirao zakonodavne akte o medicinskim proizvodima i in vitro dijagnostici kako bi se uskladio s razvojem sektora u posljednjih 20 godina. EU je... Latest updates News announcement | 24 svibanj 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devicesNews announcement | 20 svibanj 2022MDCG 2022-9 - Summary of safety and performance templateNews announcement | 20 svibanj 2022MDCG 2022-8 - Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022News announcement | 20 svibanj 2022MDCG 2022-7 - Q&A on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746Prikaži sve Highlights News announcement | 24 svibanj 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devicesNews announcement | 26 svibanj 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 activitiesCommission Implementing Regulation (EU) 2020/1207 on common specifications for the reprocessing of single-use devicesGeneral publications | 12 srpanj 2020Commission guidelines on Union-wide derogations for medical devicesGeneral publications | 26 lipanj 2020List of COVID-19 essential Medical Devices (MDs and IVDs)General publications | 24 lipanj 2020Guidance on regulatory requirements for medical face masks Events 07svi2021 Partnerski sastanci Webinar for Patients – Safe and performant Medical Devices for all Documents EventsPublications
News announcement | 24 svibanj 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices
News announcement | 20 svibanj 2022MDCG 2022-8 - Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022
News announcement | 20 svibanj 2022MDCG 2022-7 - Q&A on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746
News announcement | 24 svibanj 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices
News announcement | 26 svibanj 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
Commission Implementing Regulation (EU) 2020/1207 on common specifications for the reprocessing of single-use devices
General publications | 12 srpanj 2020Commission guidelines on Union-wide derogations for medical devices
