Pregled Na ovoj se stranici prikupljaju informacije i poveznice o pitanjima važnima za provedbu Uredbe o medicinskim proizvodima (MDR), zbog čega su... Prijavljena tijela Prijavljeno tijelo organizacija je koju je imenovala država članica EU-a (ili druga zemlja na temelju posebnih sporazuma) za ocjenjivanje sukladnosti... Jedinstvena identifikacija proizvoda – UDI Jedinstvena identifikacija proizvoda (UDI) jedinstven je numerički ili alfanumerički kod koji se odnosi na medicinski proizvod. Omogućuje jasnu i… Ponovna obradaHealth institutions reprocessing single-use devicesNational rules on reprocessing of single-use devicesUsklađene norme CEN i Cenelec kao europske organizacije za normizaciju razvijaju usklađene europske norme na temelju uredbi o medicinskim proizvodima, Latest updatesNews announcement17 svibanj 2022New publication of Harmonised standards under the medical devices RegulationsNews announcement23 ožujak 2022Update - Short overview of the information on the applications for designation as a notified bodyNews announcement4 listopad 2021The EUDAMED UDI/Devices and NBs & Certificates modules are open. Economic Operators and Notified Bodies can start entering data in EUDAMED on voluntary basisNews announcement3 rujan 2021The expert panel in the field of in vitro diagnostic medical devices now accepts submissions from notified bodies for the Performance Evaluation Consultation ProcedurePrikaži sve MD Topics of Interest - HighlightsThe 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 activitiesCommission Notice on notified bodies’ audits performed during Covid-19 exceptional circumstancesGeneral publications12 srpanj 2020Commission guidelines on Union-wide derogations for medical devicesGeneral publications26 lipanj 2020List of COVID-19 essential Medical Devices (MDs and IVDs) DocumentsPublications
News announcement17 svibanj 2022New publication of Harmonised standards under the medical devices Regulations
News announcement23 ožujak 2022Update - Short overview of the information on the applications for designation as a notified body
News announcement4 listopad 2021The EUDAMED UDI/Devices and NBs & Certificates modules are open. Economic Operators and Notified Bodies can start entering data in EUDAMED on voluntary basis
News announcement3 rujan 2021The expert panel in the field of in vitro diagnostic medical devices now accepts submissions from notified bodies for the Performance Evaluation Consultation Procedure
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
General publications12 srpanj 2020Commission guidelines on Union-wide derogations for medical devices
