Every legacy device still sold in the EU must be in EUDAMED by 28 November 2026. The dates, the exemptions, and a six-week plan that starts with your consigned and field stock.
Six weeks left: the EUDAMED legacy device deadline is 28 November 2026
Every legacy device still placed on the EU market must be registered in EUDAMED by 28 November 2026. That is the second hard date in the EUDAMED rollout, and it is closer than most registration backlogs allow. The first deadline, 28 May 2026, made four modules mandatory for new devices. This one reaches back into your whole catalogue: every directive-era device you still sell needs a record in the database.
The trap is treating this as a regulatory affairs task. The forms are. The data is not. For most MedTech companies the hard part of EUDAMED registration is knowing which legacy devices are actually still out there: consigned implants at hospitals, loaner kits between cases, demo units in the field. Ventory sees this daily in field inventory data: the device list in the ERP and the device reality at customer sites are two different documents.
The dates, in one table
The rollout clock started when the European Commission published Decision (EU) 2025/2371 on 27 November 2025, declaring four EUDAMED modules functional. Everything since follows from that date.
| Date | Milestone | Who acts |
|---|---|---|
| 27 November 2025 | Decision (EU) 2025/2371 published: four EUDAMED modules declared functional | European Commission |
| 28 May 2026 | Mandatory use starts: Actor registration, UDI/Device registration, Notified Bodies and Certificates, Market Surveillance | All economic operators |
| 28 November 2026 | Registration deadline for legacy devices still placed on the EU market | Manufacturers |
| 28 May 2027 | Legacy certificate information uploaded to EUDAMED | Notified bodies |
Registration can be due earlier than 28 November. If a legacy device is involved in a serious incident or a field safety corrective action, the Commission's legacy device guidance expects registration before the follow-up or final vigilance report.
What counts as a legacy device
Legacy devices are devices first certified under the old directives (MDD, AIMDD or IVDD) that keep selling under the MDR and IVDR transition rules. For the registration deadline the test is practical: the device was on the EU market before 28 May 2026 and you keep placing units on the market after that date. If both are true, it must be in EUDAMED by 28 November 2026.
Two nuances worth checking with your notified body or regulatory counsel:
- Equivalent MDR device already registered. Where an equivalent MDR or IVDR version of the device is already registered in EUDAMED, legacy registration may not be required for that device family. The portfolio logic has to be documented and justified.
- Devices you stopped selling. A device last placed on the market before 28 May 2026 and never since does not trigger the legacy registration duty. It can still trigger vigilance-driven registration later, so the cut needs to be deliberate, not assumed.
Why legacy registration is a field data problem
Registering a device in EUDAMED means producing structured data: Basic UDI-DI, device identifiers, risk class, intended purpose and the attributes the UDI/Device module demands. For products launched in the last few years that data exists in a PLM or regulatory system. For a directive-era catalogue it is scattered across spec sheets, old technical files and tribal memory.
And the first question is harder than any attribute: which legacy devices are still active? The honest answer lives outside the warehouse.
- Consigned stock at hospitals. Implants and instruments owned by you, sitting at customer sites, often for years. If they are still being replenished, that device is still on the market.
- Loaner kits. Sets that rotate between hospitals and the depot. The ERP shows a kit number; the regulatory question is which device versions are inside.
- Field and demo stock. Units in sales engineers' cars and clinic storerooms that never crossed a warehouse scanner since 2022.
Companies with real-time visibility of consigned and field stock can answer "which legacy devices are still out there, where, in which lot" in minutes. Companies without it start the registration sprint with a physical census. With six weeks left, that census is the critical path.
The six-week plan
A workable sequence between now and 28 November:
- Week 1: cut the catalogue. List every directive-era device code. Mark what is still being placed on the market, what stopped, and what has a registered MDR equivalent. This list is the scope.
- Week 1-2: census the field. Pull consignment, loaner and demo stock data per location. Where no reliable data exists, run cycle counts at the biggest hospital sites first.
- Week 2-4: assemble the data set. Basic UDI-DI and device attributes per device in scope. Reuse what the 28 May actor and device registrations already forced into shape.
- Week 4-6: load and verify. Machine-to-machine upload or bulk XML for volume, manual entry only for the tail. Verify record status in EUDAMED, not in the spreadsheet.
- After the deadline: fix the system. The registration sprint proves the point: device data at field locations needs to be live, not reconstructed. That is an operations fix, not a one-off project.
The proof
Ventory is the field inventory layer between the ERP and field locations. A global medtech manufacturer runs consigned and loaner stock across hundreds of hospital sites on it; a national ambulance service holds 99.76% stock accuracy across a 100-vehicle fleet. Lot, serial and expiry per device per location, scanned at the point of use. That is the data layer a legacy census needs, and the system that keeps the next compliance deadline from becoming another archaeology project. Deployment runs 4-8 weeks, so a system fix started now carries the May 2027 certificate milestone and everything after it. See how it works for medical device inventory.
Getting started
Running consigned or loaner stock on spreadsheets while a registration deadline closes in?
Field notes
- 28 November 2026 is 12 months after the Decision's publication, not 6 months after mandatory use. Diarise the real date.
- A legacy device with a registered MDR equivalent may be exempt. Documenting that logic takes an afternoon; an unneeded registration takes days.
- The census is the critical path. Attributes can be assembled in parallel; an unknown installed base cannot.
Frequently asked questions
What are the EUDAMED registration deadlines for legacy devices?
Legacy devices still being placed on the EU market must be registered in EUDAMED by 28 November 2026, 12 months after the Commission published Decision (EU) 2025/2371. Registration is due earlier if the device is involved in a serious incident or field safety corrective action. Notified bodies have until 28 May 2027 to upload legacy certificate information.
Which EUDAMED modules are already mandatory?
Four modules became mandatory on 28 May 2026: Actor registration, UDI/Device registration, Notified Bodies and Certificates, and Market Surveillance. Vigilance and Clinical Investigations follow later in the rollout.
What is a legacy device under the MDR?
A device first certified under the old directives (MDD, AIMDD or IVDD) that continues to be placed on the market under the MDR or IVDR transition provisions. For the 28 November 2026 deadline the practical test is: on the market before 28 May 2026 and still being placed after it.
Do legacy devices need a full UDI?
Legacy devices are registered with a EUDAMED identifier (EUDAMED DI) rather than a full UDI assignment where no UDI exists yet. The device record still requires structured attributes, so the data work is comparable. Your notified body can confirm the identifier route per device family.
What happens if a legacy device is not registered by 28 November 2026?
The device falls out of compliance with the EUDAMED registration obligations that now apply, which surfaces at audits, tenders and incident handling. An unregistered device becomes a commercial risk before it is an enforcement one.
How does field inventory data help with EUDAMED compliance?
Registration scope depends on knowing which devices are still active at hospitals and field locations. A field inventory layer tracks consigned stock, loaner kits and demo units by lot, serial and expiry in real time, so the legacy census is a report, not a project. The same data feeds UDI traceability at the point of use after the deadline.
About Ventory
Ventory is the field inventory layer for regulated, high-stakes industries. We give MedTech, 3PL, Aerospace, Energy and FMCG leaders real-time visibility and control over inventory outside the four walls, in hospitals, ambulances, trunk stock, consignment locations, and field service vans. Ventory is ERP-agnostic (SAP, Oracle, Dynamics, Sage, NetSuite) and trusted by a global medtech manufacturer, a national ambulance service, global logistics and consumer-goods operators. See how it works →
Ten questions. You get a field readiness score, a gap tier and the three fixes worth doing first.
Ventory is the field inventory layer between your ERP or WMS and the teams working outside the warehouse: engineer vans, forward stocking locations, consigned stock and loaner kits.
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