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Legacy Devices under EUDAMED: Obligations and Exceptions

Introduction

Legacy devices represent a particular challenge for medical device manufacturers when it comes to determining whether or not they must be registered in the EUDAMED regulatory database.
These medical devices, which comply with the former European directives, may continue to be marketed thanks to the transitional periods provided in the regulations, but they do not benefit from the features granted to devices under the MDR/IVDR.
For many manufacturers, legacy devices still make up a significant portion of their product catalog. Understanding precisely when and how to register them in EUDAMED is crucial to avoid any disruption in market access.
Faced with strict obligations and notable exceptions, this article guides you through the decisions to make and the actions to anticipate.

Manual Entry or Automation: Which Approach Is Right for Registering Your Devices in EUDAMED?

Registering medical devices in EUDAMED is a major challenge for all manufacturers. Faced with this regulatory obligation, one crucial question arises: should you rely on manual entry or automate the process? The answer depends primarily on your number of product references — but not only that.

Data Version Management in EUDAMED

Data version management in EUDAMED is a critical issue that is often poorly understood by medical device manufacturers. Unlike a traditional database, EUDAMED is based on strict traceability, in which certain data is considered immutable. Any modification of these so-called non-modifiable attributes requires the creation of a new UDI-DI identifier, with significant consequences for operational processes.

Each time UDI-DI data is submitted, the quality of the information transmitted is therefore paramount: the possibilities for correction are either non-existent or very limited and conditional. An error in a critical attribute can thus have disproportionate impacts, including the relabeling of devices already in stock with a new UDI-DI. Understanding these versioning rules, as well as the criteria that trigger a new UDI-DI, is therefore essential to anticipate impacts and avoid costly errors.