Tracker entry M17: Medical Device Regulation: UDI and EUDAMED
Phasing in
EU
Next date
in 26 days
Deadline to register devices placed on the market before 28 May 2026 in EUDAMED
- Region
- EU
- Sector
- Healthcare
- Imposed by
- European Commission
- Applies to
- Medical device manufacturers
- Technology
- RFID one option
What the rule requires
Every device carries a UDI in automatic identification and data capture (AIDC) form, and the MDR counts RFID as an AIDC technology alongside barcodes. Reusable instruments, the main use case for RFID tracking of theatre trays, must be directly marked. The last Class I direct-marking deadline is 26 May 2027, and the Dec 2025 reform proposal would move some reusable surgical instruments to a lower risk class.
Status: In force; UDI label deadlines complete; last direct-marking deadline 26 May 2027; EUDAMED mandatory since 28 May 2026
What it means for RFID
The MDR does not require RFID, but it does recognise it: every device's UDI must be in automatic identification and data capture (AIDC) form, and RFID counts as an AIDC technology alongside barcodes. That gives medical device manufacturers the option of carrying the UDI on an RFID tag.
The part that matters most for RFID is direct marking of reusable devices, because reusable instruments, such as those tracked on theatre trays, are the main RFID use case. Reusable Class III devices have had to be directly marked since 26 May 2023 and Class IIa and IIb since 26 May 2025, and reusable Class I devices follow on 26 May 2027.
Two things to watch: the 28 November 2026 deadline to register devices placed on the market before 28 May 2026 in EUDAMED, and the targeted revision the Commission proposed on 16 December 2025, still in negotiation, which would move some reusable surgical instruments to a lower risk class.
Timeline
- MDR applies; UDI on labels of Class III and implantable devices
- UDI on labels of Class IIa and IIb devices; direct marking of reusable Class III devices
- UDI on labels of Class I devices; direct marking of reusable Class IIa and IIb devices
- Commission Decision (EU) 2025/2371 confirms four EUDAMED modules are working
- Commission proposes a targeted revision of the MDR and IVDR (still in negotiation)
- Use of EUDAMED actor, UDI/device, certificate and market surveillance modules becomes mandatory
- Deadline to register devices placed on the market before 28 May 2026 in EUDAMED
- Direct marking of reusable Class I devices
- Deadline to register certificates issued before 28 May 2026
Sources
Official source: HPRA (Irish regulator) and GS1 Belgium and Luxembourg
Last checked against the official source on 1 November 2026.
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