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Medical devices are products or equipment intended for a medical purpose. In the European Union (EU) they must undergo a conformity assessment to demonstrate they meet legal requirements to ensure they are safe and perform as intended.
26 Μαΐ 2021 · The Medical Device Regulation (MDR), which was adopted in April 2017, changes the European legal framework for medical devices and introduces new principal and supportive responsibilities for EMA and for national competent authorities in the assessment of certain categories of products.
14 Μαρ 2023 · EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746…
The European Medicines Agency works closely with the national competent authorities of the Member States of the European Union (EU) and the European Economic Area (EEA) responsible for human medicines.
Latest update: All European Competent Authorities (CAs) work together in the Competent Authorities for Medical Devices (CAMD) network to promote patient safety through the consistent development and application of the medical devices regulatory system.
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance.
5 ημέρες πριν · The phased roll-out of Eudamed, the European database for medical devices, is one of the most significant changes in the regulatory landscape for manufacturers.Under Regulation (EU) 2024/1860, the European Union has outlined a clear plan for the gradual implementation of Eudamed, with specific deadlines for each module to become mandatory for manufacturers, importers, and authorized ...
