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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