Legacy Devices in EUDAMED: How to Setup, Obligations and Exceptions

Legacy devices present a unique regulatory challenge under the European Union Medical Device Regulation and In Vitro Diagnostic Regulation frameworks. While these devices remain legally marketable during defined transition periods, they do not fully benefit from the MDR and IVDR regulatory infrastructure, including streamlined identification and traceability mechanisms.

For many manufacturers, legacy devices still account for a substantial share of active portfolios. Understanding when these products must be registered in EUDAMED, and under which conditions exemptions apply, is critical to avoiding market disruption and compliance risk.

This article explains what qualifies as a legacy device, clarifies EUDAMED registration obligations, highlights key exceptions, and outlines practical strategies to stay ahead of upcoming deadlines.

What Is a Legacy Device?

What a Legacy Device Is Not

A legacy device is not a medical device or in vitro diagnostic device already certified under MDR Regulation (EU) 2017/745 or IVDR Regulation (EU) 2017/746.

It is also not a device that was placed on the market before the MDR or IVDR dates of application and is no longer being placed on the market today.

Regulatory Definition

A legacy device is a medical device or IVD that:

• Is CE marked under the MDD, AIMDD, or IVDD
• Qualifies for transitional provisions under Article 120 of MDR or Article 110 of IVDR
• Continues to be placed on the EU market after May 26, 2021 for medical devices or May 26, 2022 for IVDs

To benefit from transitional provisions, several conditions must be met. These include continued compliance with the former directives, no significant design or intended use changes, appropriate notified body certification where required, an MDR or IVDR compliant quality management system within the mandated timelines, a valid notified body contract, and fulfillment of post market surveillance, vigilance, and economic operator obligations.

Is Registration of Legacy Devices in EUDAMED Mandatory?

General Rule

Registration of legacy devices in EUDAMED becomes mandatory once the UDI and Device module is fully applicable, currently expected in the third quarter of 2026, unless a corresponding MDR or IVDR device is already registered.

The Corresponding Device Exception

A legacy device may be exempt from registration if a corresponding MDR or IVDR device exists and shares the same identification, risk class, and key characteristics. If any of these elements differ, a new UDI-DI is required, and both the legacy and MDR or IVDR devices must be registered.

Vigilance Driven Registration

Even when a legacy device is normally exempt, a vigilance action may trigger a registration obligation. If a serious incident or corrective action specifically concerns the legacy device, it must be registered in the EUDAMED Device module to allow reporting.

Old devices that are no longer placed on the market are not considered legacy devices and generally do not require registration unless involved in a vigilance event.

How to Register Legacy Devices in EUDAMED

Legacy devices were not originally required to carry a Basic UDI-DI or UDI-DI. However, EUDAMED registration introduces this requirement.

Manufacturers may continue to use existing identifiers such as a GTIN, provided no changes have occurred that could affect traceability.

Two registration approaches are available:

1. Use an existing UDI-DI and construct a Basic UDI-DI by prefixing it with a B
2. Generate an EUDAMED ID to serve as the UDI-DI and create an EUDAMED-DI as the Basic UDI-DI

Identifiers created for legacy devices cannot be reused for MDR or IVDR certified devices.

Registration Timeline and Critical Dates

The obligation to register devices is triggered by publication in the Official Journal of the European Union confirming EUDAMED’s full functionality. This publication is currently anticipated in late 2025.

Based on this timeline, all legacy devices still on the market are expected to be registered in the UDI and Device module by the fourth quarter of 2026.

Vigilance events override this timeline. To submit a vigilance report, the manufacturer must hold a Single Registration Number and the device must already be registered in EUDAMED, effectively accelerating registration requirements.

Transition Periods vs Registration Deadlines

Transitional periods define how long a device may continue to be sold, while registration obligations define when a device must be entered into EUDAMED.

A device may need to be registered well before its final market withdrawal date. Confusing these timelines is a common and costly mistake.

Practical Scenarios

A Class IIb device certified under the MDD and still marketed in late 2026 must be registered before that date, even if its certificate remains valid until 2028.

In mixed product lines where some references have transitioned to MDR and others have not, only the non transitioned devices require registration unless a vigilance event occurs.

If a serious incident involves a normally exempt legacy device, immediate registration is required to enable reporting.

Common Pitfalls

Manufacturers frequently underestimate registration timelines, reuse Basic UDI-DIs incorrectly between MDD and MDR devices, or overlook the impact of vigilance actions on registration obligations.

Recommended Strategies

Manufacturers with a small number of legacy devices should begin with a comprehensive inventory, prioritize devices at risk, and prepare data early for batch submissions.

Those managing large portfolios should perform an impact assessment, consider automation and machine to machine connectivity, and centralize oversight of MDD and MDR data to reduce operational risk.

Moving Forward with Confidence

Legacy devices are not simply remnants of past regulations. They are a critical bridge between regulatory frameworks.

With clear understanding, early planning, and the right tools, manufacturers can manage this transition smoothly while maintaining uninterrupted access to the European market.

Time is limited. Acting now ensures compliance, resilience, and long term continuity.

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