Prehľad Tu nájdete informácie a odkazy o otázkach, ktoré sú relevantné z hľadiska vykonávania nariadenia o zdravotníckych pomôckach. Pretože… Notifikované osoby Notifikovaná osoba je organizácia autorizovaná členským štátom EÚ (alebo inými krajinami na základe osobitných dohôd) na to, aby posudzovala zhodu… Unikátny identifikátor pomôcky – UDI Unikátna identifikácia pomôcky (UDI) je jedinečný číselný alebo alfanumerický kód súvisiaci so zdravotníckou pomôckou. Umožňuje jasnú a jednoznačnú… RenovovanieHealth institutions reprocessing single-use devicesNational rules on reprocessing of single-use devicesHarmonizované normy Harmonizované normy podľa nariadení o zdravotníckych pomôckach vypracúvajú výbory CEN a CENELEC – európske normalizačné organizácie Latest updatesNews announcement17 máj 2022New publication of Harmonised standards under the medical devices RegulationsNews announcement23 marec 2022Update - Short overview of the information on the applications for designation as a notified bodyNews announcement4 október 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 september 2021The expert panel in the field of in vitro diagnostic medical devices now accepts submissions from notified bodies for the Performance Evaluation Consultation ProcedureZobraziť všetky 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 júl 2020Commission guidelines on Union-wide derogations for medical devicesGeneral publications26 jún 2020List of COVID-19 essential Medical Devices (MDs and IVDs) DocumentsPublications
News announcement17 máj 2022New publication of Harmonised standards under the medical devices Regulations
News announcement23 marec 2022Update - Short overview of the information on the applications for designation as a notified body
News announcement4 október 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 september 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
