EU: The European Commission issues a guidance on management of legacy devices in Eudamed
The European Commission issued a new guidance explaining how legacy devices and in vitro diagnostics (IVDs) will be managed in its Eudamed database, expected to be fully rolled out by May 2022.
“Legacy Devices are defined as Medical Devices, Active Implantable Medical Devices and In Vitro Diagnostic Medical Devices that are covered by a valid certificate issued in accordance with Directive 93/42/EEC, Directive 90/385/EEC or Directive 98/79/EC and that continue to be placed on the market after the date of application of Regulation (EU) 2017/745 (MDR) or Regulation 2017/746 (IVDR).”
In general, the Commission says that, “Legacy Devices are subject to the MDR or IVRD registration requirements with some exceptions such as the assignment of a Basic [universal device identification-device identifier] UDI-DI and a UDI-DI.”
The document also explains how to link “regulation devices” to legacy devices after they become compliant with MDR or IVDR and provides information about the format of the Eudamed DI when it is not generated from a UDI-DI.
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For more details, please see the guidance from the European Commission.
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This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
