What is a Legacy Device?

What a legacy device is not

A legacy device is not a Medical Device (MD) or an In Vitro Diagnostic Device (IVD) that is already certified under the MDR (Regulation (EU) 2017/745) or the IVDR (Regulation (EU) 2017/746).
A legacy device is also not an old device placed on the market under the previous directives — MDD 93/42/EEC, AIMDD 90/385/EEC, or IVDD 98/79/EC — or under rules predating those directives, by the manufacturer or importer, before the date of application of the MDR/IVDR (i.e., before May 26, 2021 for MDs and before May 26, 2022 for IVDs).

Regulatory Definition of a legacy device

A legacy device is:

• A Medical Device (MD) or In Vitro Diagnostic Device (IVD)
• CE-marked under the MDD, AIMDD, or IVDD directives
• Eligible for the transitional provisions (Article 120 MDR or Article 110 IVDR)
• Placed on the EU market after the date of application of the MDR/IVDR (i.e., after May 26, 2021 for MDs and after May 26, 2022 for IVDs)

Note: To qualify for the transitional provisions (point 3), the following conditions must be met:

• The device must still comply with the MDD/AIMDD/IVDD directives
• No significant changes must have been made to the design and/or intended purpose
• The device must be certified by a Notified Body (except for Class I MDs and Class A IVDs)
• The Quality Management System (QMS) must comply with MDR/IVDR requirements (as of May 2024 for MDs and May 2025 for IVDs)
• A contract must be signed with a Notified Body within the required timeframe (depending on classification and status)
• MDR requirements for post-market surveillance, vigilance, and economic operator registration must be fulfilled

Is it mandatory to register legacy devices in EUDAMED?

General Rule

Registration of a legacy device in EUDAMED becomes mandatory once the UDI/Device module is fully applicable (Q3 2026), unless the corresponding regulation device is already registered.

The exception related to the corresponding device

A corresponding MDR/IVDR device has:

• The same identification (e.g., UDI-DI or commercial reference)
• The same risk class
• The same characteristics (e.g., implantable, active)

If these conditions are not met, a new UDI-DI is required when changes could lead to misidentification or ambiguity in traceability.
In such cases, both the legacy device and the MDR/IVDR device must be registered in EUDAMED.

Impact of a vigilance action

In the event of a vigilance action involving a legacy device, and if a corresponding MDR/IVDR device exists, the legacy device must be exceptionally registered in the Device module only if the vigilance action concerns the legacy device specifically.
Otherwise, referencing the corresponding MDR/IVDR device is sufficient.

Note: Old devices are not considered legacy devices and therefore do not need to be registered in EUDAMED — except in the case of a vigilance action.

How to register legacy devices in EUDAMED

Legacy devices have specific characteristics. As they fall under the former directives, they are not legally required to be identified by a Basic UDI-DI and UDI-DI.
However, manufacturers may have chosen to identify such devices using a GTIN (assuming GS1 is the issuing entity selected), primarily for logistical reasons.
The GTIN is one of the possible formats for the UDI-DI and may continue to be used for EUDAMED registration, provided that no changes have been made that could lead to misidentification or ambiguity in traceability.

The question of Basic UDI-DI and UDI-DI

It is the registration in EUDAMED — not the MDR/IVDR regulations themselves — that makes the use of a Basic UDI-DI and UDI-DI mandatory for a legacy device.

Thus, two options are available:

1. Use the existing UDI-DI of the MD/IVD
2. Generate an EUDAMED-ID (which corresponds to the UDI-DI)

Constructing the Basic UDI-DI

Option 1 – Using the existing UDI-DI

• Create the Basic UDI-DI by prefixing the UDI-DI with a “B”
• Maintain a one-to-one relationship between Basic UDI-DI and UDI-DI
• The Basic UDI-DI cannot be reused under MDR/IVDR

Option 2 – Generating an EUDAMED-ID

• Generate an EUDAMED code (the EUDAMED-ID serves as the UDI-DI)
• Create an EUDAMED-DI (serving as the Basic UDI-DI) by prefixing the EUDAMED-ID with a “B”
• Neither the EUDAMED-DI nor EUDAMED-ID can be reused under MDR/IVDR

Registration Timeline for legacy devices

General Rule

The obligation to register MDs/IVDs in EUDAMED is triggered by publication in the Official Journal of the European Union (OJEU) confirming EUDAMED’s full functionality.
As of September 2025, this publication is expected by mid-November 2025.
Therefore, all legacy devices still on the market must be registered in the UDI/Device module no later than Q4 2026, assuming publication occurs in Q4 2025.

Special case: Vigilance

Even if exempt from mandatory registration, a vigilance event involving a legacy device may require submitting a vigilance report in the EUDAMED Vigilance module.
Types of vigilance actions include:

• Serious incident
• FSCA (Field Safety Corrective Action)
• FSN (Field Safety Notice)
• Trend report

Vigilance report submission deadlines (Article 87 MDR):

• Serious incident resulting in death or serious deterioration of health → within 10 calendar days after the manufacturer becomes aware
• Serious incident not resulting in death or serious deterioration → within 15 calendar days
• Serious public health threat → within 2 calendar days

Prerequisites for submitting vigilance reports

• The manufacturer must be registered and have a Single Registration Number (SRN)
• The device must be registered in EUDAMED

Although the MDR does not specify a strict deadline for registering legacy devices, these prerequisites effectively shorten the registration timeline — particularly in vigilance contexts.
Note: Many manufacturers choose to proactively register their exempted legacy devices if they are — or could be — subject to vigilance actions.

Transition Periods: Don’t Confuse Them with Registration Deadlines

Sales deadlines by risk class

It’s essential to distinguish between:

• The transitional period, which defines how long the manufacturer can sell the device
• The registration obligation, which defines when the device must be registered in EUDAMED

Impact on your strategy

• A device may need to be registered well before its final sales date
• Registration in EUDAMED is required to continue marketing
• Planning must consider both timelines

Practical Cases and Examples

Example 1: Class IIb device under MDD

• MDD certificate valid until 2028
• Still marketed in Q4 2026
• Required action: Mandatory registration before Q4 2026
• Basic UDI-DI: Specific to the legacy device

Example 2: Mixed MDD/MDR product line

• Some references already transitioned to MDR
• Others still under MDD
• Required action: Only non-transitioned devices must be registered
• Note: A vigilance action may require registration of others

Example 3: Incident involving a legacy device

• Device normally exempt (corresponding MDR device exists)
• Serious incident occurs
• Required action: Immediate registration required to report in the Vigilance module

Common Pitfalls to Avoid

• Confusing timelines: Assuming long transition means delayed registration
• Poor Basic UDI-DI management: Using the same Basic UDI-DI for MDD and MDR (leads to rejection)
• Neglecting vigilance cases: Forgetting that vigilance actions require prior registration

Recommended Strategies

For manufacturers with a limited number of legacy devices

• Comprehensive inventory: list all active legacy devices
• Prioritization: identify which require registration
• Manual preparation: start compiling data now
• Batch registration: plan grouped submissions

For manufacturers with a large number of legacy devices

• Impact analysis: assess volume and complexity
• Automation: consider an M2M (machine-to-machine) solution
• Progressive migration: prioritize MDR transition
• Centralized management: unify MDD/MDR oversight

Using an M2M solution

The Ackomas solution enables legacy devices to be processed like MDR/IVDR devices.
It supports the strict rules applicable to legacy devices and includes intelligent management of Basic UDI-DIs.

Conclusion: A Well-Managed Transition Toward the Future

Managing legacy devices in EUDAMED perfectly illustrates the complexity of today’s regulatory transition. Between strict obligations and subtle exceptions, each manufacturer must navigate a maze of rules that can sometimes seem contradictory.
Yet, with a clear understanding of requirements and careful planning, this transition becomes manageable.

Legacy devices are not a burden from the past — they are a bridge to the future of European regulation.
By mastering their registration in EUDAMED, you demonstrate your ability to handle complexity while ensuring business continuity.

Time is running out. With less than a year before the first critical deadlines, the time to act is now.
Assess your portfolio of legacy devices, identify your obligations, and implement a tailored strategy.
Your ability to continue serving European customers depends on it.

Want to go further?

• Download the practical EUDAMED guide →
• Discover how Ackomas manages your legacy devices →

Last updated: October 2025. Regulations are evolving. Please consult official sources and your regulatory advisor for the most up-to-date information.