Module 16 2022

9/2/2022

Eudamed and legacy devices Registration

When do manufacturers have to register legacy devices?

Legacy devices shall be registered in EUDAMED in two cases:

• a post-market surveillance and/or a vigilance report occurs; • by the end of the transition period applicable for device registration, if no equivalent MDR or IVDR device is registered in EUDAMED. Guidance MDCG 2019-5 identifies the mandatory registration of legacy devices when a serious incident occurs or when there is a field safety corrective action to apply on them, requiring their registration as soon as possible and at least before a follow-up or final vigilance report is submitted.

Source: https://eu-udi.zendesk.com/hc/en-150/articles/360019389377-What-about-Legacy-devices

9/2/2022

The Organisation for Professionals in Regulatory Affairs

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Eudamed and legacy devices Registration

Source: https://eu-udi.zendesk.com/hc/en-150/articles/360019389377-What-about-Legacy-devices

9/2/2022

The Organisation for Professionals in Regulatory Affairs

40

40