The European Commission has published a new guidance document titled ‘Management of Legacy Devices, MDR EUDAMED‘, explaining “how Legacy Devices will be identified in EUDAMED and the way the different Unique Device Identifiers for the Legacy Devices will be generated/assigned”.
The document clarifies that “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).”
It continues by stating that: “Manufacturers will have the possibility to register any of their Legacy Devices in EUDAMED. As explained in the guidance document, their registration will be mandatory in case a serious incident occurs or there is a field safety corrective action to apply, which requires registration as soon as possible and at least before a follow up or final vigilance report is submitted.”
Furthermore, it explains that: “If 18 months after the date of application of the MDR or IVDR, the equivalent device is not made [MDR/IVDR] compliant and registered as a MDR or IVDR device, the Legacy Device must be registered in EUDAMED within this time period.”