Europe – EC : Management of Legacy Devices – MDR EUDAMED

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).
Guidance on registration of legacy devices in EUDAMED is provided in the « MDCG 2019-5 “Registration of legacy devices in EUDAMED April 2019 » document (https://ec.europa.eu/docsroom/documents/34922).
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, if 18 months after the date of application of the MDR or IVDR (or 24 months after the date of publication of the notice referred to in Article 34(3) if EUDAMED is not fully functional before the date of application of the MDR), the equivalent device is not made compliant and registered as a MDR or IVDR device, the Legacy Device must be registered in EUDAMED within this time period. Legacy Devices with the risk class I that are not sterile and/or with a measuring function under the Directives cannot be considered as Legacy Devices because they do not require a certificate issued by a Notified Body.
These must be registered only as Regulation Devices in EUDAMED within the 18 months after the date of application (or 24 months after the date of publication of the notice referred to in Article 34(3) if EUDAMED is not fully functional before the date of application of the MDR)…