EU medical devices · MDR (EU) 2017/745, Art 27
Does your device need a UDI — and by when?
Under the MDR, every device other than a custom-made device must carry a UDI (Basic UDI-DI + UDI-DI + UDI-PI) on its label and be registered in EUDAMED. The carrier deadline depends on risk class, reusable devices get a later direct-marking deadline, and EUDAMED is mandatory from 28 May 2026. Find your position.
The rule, in one line
Under Regulation (EU) 2017/745 (MDR), Article 27 + Annex VI, before placing a device — other than a custom-made device — on the market the manufacturer assigns a Basic UDI-DI and a UDI (a UDI-DI specific to the device + a UDI-PI identifying the production unit), places the UDI carrier on the label and all higher packaging levels, and registers the device in EUDAMED. The UDI-carrier deadline runs by risk class (implantable & Class III: 26 May 2021; Class IIa & IIb: 26 May 2023; Class I: 26 May 2025); reusable devices needing reprocessing get a direct-marking deadline two years later. The EUDAMED UDI/Device + Actor modules are mandatory from 28 May 2026. This tool covers MDR devices only — not IVDs (IVDR has different classes and dates).
Official sources: Reg (EU) 2017/745 (MDR) · EC UDI Helpdesk — deadlines · EC — EUDAMED registration
MDR UDI verdict
UDI required
This device needs a UDI. Assign a Basic UDI-DI + UDI-DI + UDI-PI, place the UDI carrier on the label and all higher packaging levels, and register the device in EUDAMED. The deadlines below are set by your risk class.
Your obligations
- Assign a Basic UDI-DI + UDI-DI + UDI-PI and place the UDI carrier on the label and all higher packaging levels. Class deadline: 26 May 2021 (deadline already passed).
- Obtain the UDI from a Commission-designated issuing entity.
- Register the UDI/Device information and your Actor data in EUDAMED. Mandatory from 28 May 2026 (mandatory now).
Per-device memo
UDI & EUDAMED memo (PDF) · €29
A print-ready pack for one device: the UDI verdict, the carrier + direct-marking deadlines for its class, the single-use relaxation, the EUDAMED position, and source links — for your technical documentation.
This is guidance, not legal or regulatory advice. The export restates the position for your inputs; it relies on the risk class you provide and does not classify the device.
What this tool is — and isn't
This checker routes the MDR UDI-carrier + EUDAMED position by device type and risk class under Regulation (EU) 2017/745, Article 27 + Annex VI, using EUR-Lex + the European Commission's UDI Helpdesk and EUDAMED pages. It covers MDR devices ONLY — not in-vitro diagnostics (IVDR, Reg (EU) 2017/746, has different classes A/B/C/D and different deadlines). It does not classify your device — the risk class is your input, and a wrong class invalidates the result. The EUDAMED 28 May 2026 date rests on Commission Decision (EU) 2025/2371 + the Reg (EU) 2024/1860 transitional provisions and has historically slipped — confirm it at use-time. It is an estimate and orientation, not legal/regulatory advice. Verify against the linked official sources and Annex VI.
How the determination works
1. The device-type gate
Custom-made devices are excluded from UDI assignment; investigational devices are outside the standard UDI database submission; system/procedure packs follow Article 29. Standard MDR devices continue to the deadline logic.
2. Risk class sets the deadline
The UDI-carrier placement deadline runs by class — implantable & Class III first (26 May 2021), then Class IIa/IIb (26 May 2023), then Class I (26 May 2025). The tool shows whether that deadline has already passed.
3. Reusable, single-use, and EUDAMED overlays
Reusable devices needing reprocessing get a direct-marking deadline two years later. Single-use Class I/IIa individually packaged may carry the UDI on a higher packaging level only. And the EUDAMED UDI/Device + Actor modules are mandatory from 28 May 2026 regardless.
Frequently asked questions
- What is a UDI made of?
- A UDI comprises a UDI-DI (a device identifier specific to a manufacturer and device) and a UDI-PI (a production identifier — serial/lot number, software ID, manufacturing and/or expiry date). The manufacturer also assigns a Basic UDI-DI, the main access key in EUDAMED that appears on the declaration of conformity, technical documentation and certificates.
- When did the UDI-carrier deadline apply to my class?
- UDI carrier on the label/packaging: implantable & Class III by 26 May 2021, Class IIa & IIb by 26 May 2023, Class I by 26 May 2025. The tool shows whether the deadline for your class has already passed.
- What is the direct-marking obligation?
- Reusable devices that require reprocessing/sterilisation between uses must also carry the UDI by direct marking on the device itself — two years after the label deadline (Class III/implantable 26 May 2023, Class IIa/IIb 26 May 2025, Class I 26 May 2027).
- Do custom-made or investigational devices need a UDI?
- No. Custom-made devices are excluded from UDI assignment, and investigational devices are outside the standard UDI database submission — though other MDR obligations apply. The tool flags both.
- When is EUDAMED mandatory?
- The first four EUDAMED modules — Actor registration, UDI/Device registration, Notified Bodies & Certificates, and Market Surveillance — become mandatory on 28 May 2026 (Commission Decision (EU) 2025/2371; Reg (EU) 2024/1860 transitional provisions). The rollout has historically slipped, so confirm at use-time.
- Is this legal advice?
- No. This tool routes the UDI/EUDAMED position from the risk class you provide; it does not classify devices and covers MDR only, not IVDR. It is orientation, not legal/regulatory advice. Verify against the linked official sources and Annex VI.