PregledNa ovoj se stranici prikupljaju informacije i poveznice o pitanjima važnima za provedbu Uredbe o medicinskim proizvodima (MDR), zbog čega su...Prijavljena tijelaPrijavljeno tijelo organizacija je koju je imenovala država članica EU-a (ili druga zemlja na temelju posebnih sporazuma) za ocjenjivanje sukladnosti...Jedinstvena identifikacija proizvoda – UDIJedinstvena identifikacija proizvoda (UDI) jedinstven je numerički ili alfanumerički kod koji se odnosi na medicinski proizvod. Omogućuje jasnu i…Ponovna obradaHealth institutions reprocessing single-use devicesManufacturers MDManufacturers of devices without an intended medical purposeHealthcare professionals and health institutionsNational rules on reprocessing of single-use devicesUsklađene normeCEN i Cenelec kao europske organizacije za normizaciju razvijaju usklađene europske norme na temelju uredbi o medicinskim proizvodima, Latest updatesNews announcement13 siječanj 2023Update - Coverage of designation codes by MDR/IVDR notified bodies - January 2023News announcement15 prosinac 2022Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 - Version2 - December 2022 News announcement26 listopad 2022Notified bodies survey on certifications and applicationsNews announcement7 rujan 2022Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (September 2022)Prikaži 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
PregledNa ovoj se stranici prikupljaju informacije i poveznice o pitanjima važnima za provedbu Uredbe o medicinskim proizvodima (MDR), zbog čega su...
Prijavljena tijelaPrijavljeno tijelo organizacija je koju je imenovala država članica EU-a (ili druga zemlja na temelju posebnih sporazuma) za ocjenjivanje sukladnosti...
Jedinstvena identifikacija proizvoda – UDIJedinstvena identifikacija proizvoda (UDI) jedinstven je numerički ili alfanumerički kod koji se odnosi na medicinski proizvod. Omogućuje jasnu i…
Ponovna obradaHealth institutions reprocessing single-use devicesManufacturers MDManufacturers of devices without an intended medical purposeHealthcare professionals and health institutionsNational rules on reprocessing of single-use devices
Usklađene normeCEN i Cenelec kao europske organizacije za normizaciju razvijaju usklađene europske norme na temelju uredbi o medicinskim proizvodima,
News announcement13 siječanj 2023Update - Coverage of designation codes by MDR/IVDR notified bodies - January 2023
News announcement15 prosinac 2022Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 - Version2 - December 2022
News announcement7 rujan 2022Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (September 2022)
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
