Guidance on legacy devices regarding Eudamed

Legacy devices are products that have been CE marked in the context of the current Directives but not under Regulations (EU) 2017/745 and 2017/746 on medical devices or in vitro diagnostic medical devices (MDR and IVDR) respectively. The Management of Legacy Devices, published by the European Commission, explains how and when legacy devices will be identified in the new Eudamed medical device database. 

One of the opening sections explains that manufacturers will be able to register any of their legacy devices in Eudamed. It goes on to say that if there is a serious incident or a field safety corrective action (FSCA), registration should be done immediately and at least before a follow up or final vigilance report is put forward.

When it comes to deadlines, the document says that “if 18 months after the date of application of the MDR or IVDR -or 24 months after the commission publishes a notice saying that Eudamed is ready to go live (MDR 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”. This is understood to mean that not only MDR/IVDR-compliant devices must be registered by 26 May 2024, but also legacy devices if no ‘equivalent’ MDR/IVDR device has been placed on the market and registered on Eudamed. This is taking for granted that the current goal of 26 May 2022 for a fully functional Eudamed database will be met. Registration of MDR compliant devices on Eudamed will be voluntary before that date, when the Eudamed module on device registration is ready, hopefully in September 2021.

Class I legacy devices under the Directives that are not sterile, and/or with a measuring function are not deemed legacy devices because they do not need a notified body certificate. They must be registered only as Regulation Devices (MDR/IVDR) in Eudamed by 26 May 2024.

We would highly suggest to review the corresponding document, which can be accessed in our Download Section Guidance Documents MDR pos. 28 and Download Section Guidance Documents IVDR pos. 16, or sent upon request.

Source: Medtech Insight (an Informa product)

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