Ħarsa ġenerali Din it-tema tiġbor informazzjoni u links dwar kwistjonijiet li huma rilevanti għall-implimentazzjoni tar-Regolament dwar Apparati Mediċi (MDR). Għalhekk, in-... Korpi Notifikati Korp notifikat hu organizzazzjoni maħtura minn Stat Membru tal-UE (jew minn pajjiżi oħrajn skont ftehimiet speċifiċi) biex jivvaluta l-konformità ta’… Identifikatur Uniku tal-Apparati - UDI L-identifikazzjoni unika tal-apparat (UDI) hija kodiċi numeriku jew alfanumeriku uniku relatat ma’ apparat mediku. Hi tippermetti identifikazzjoni… RiproċessarHealth institutions reprocessing single-use devicesNational rules on reprocessing of single-use devicesHarmonised standards Harmonised European standards under the medical devices Regulations are developed by CEN and Cenelec as European standardisation organisations, Latest updatesNews announcement | 17 Mejju 2022New publication of Harmonised standards under the medical devices RegulationsNews announcement | 23 Marzu 2022Update - Short overview of the information on the applications for designation as a notified bodyNews announcement | 4 Ottubru 2021The EUDAMED UDI/Devices and NBs & Certificates modules are open. Economic Operators and Notified Bodies can start entering data in EUDAMED on voluntary basisNews announcement | 3 Settembru 2021The expert panel in the field of in vitro diagnostic medical devices now accepts submissions from notified bodies for the Performance Evaluation Consultation ProcedureAra kollox 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 publications | 12 Lulju 2020Commission guidelines on Union-wide derogations for medical devicesGeneral publications | 26 Ġunju 2020List of COVID-19 essential Medical Devices (MDs and IVDs) DocumentsPublications
News announcement | 17 Mejju 2022New publication of Harmonised standards under the medical devices Regulations
News announcement | 23 Marzu 2022Update - Short overview of the information on the applications for designation as a notified body
News announcement | 4 Ottubru 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 announcement | 3 Settembru 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 publications | 12 Lulju 2020Commission guidelines on Union-wide derogations for medical devices
