[co-author: Silvia López Arnao]
On 15 February 2021, the European Commission published guidance on the Management of legacy devices in EUDAMED. This guidance addresses the registration and identification of legacy devices in EUDAMED. Legacy devices are devices that are covered by a valid certificate issued in accordance with Directive 93/42 concerning medical devices, Directive 90/385 on the approximation of the laws of the Member States relating to active implantable medical devices, or Directive 98/79 on in vitro diagnostic medical devices (“the Medical Devices Directives”) and that continue to be placed on the market after the date of application of Regulation 2017/745 on medical devices (“MDR”) or Regulation 2017/746 on in vitro diagnostic medical devices (“IVDR”).

Related Keywords

, European Commission , Member States , Medical Devices , Medical Devices Directives , Unique Device Identifier , ஐரோப்பிய தரகு , உறுப்பினர் மாநிலங்களில் , மருத்துவ சாதனங்கள் , மருத்துவ சாதனங்கள் வழிமுறைகள் ,