EUDAMED November 2026 Deadline
All medical devices CE-marked under MDD, AIMDD, or IVDD must be registered in EUDAMED by November 28, 2026. After that date, non-registered legacy devices cannot remain on the EU market.
Time remaining
November 28, 2026 - EU legacy device registration deadline
What is the November 2026 deadline?
Under Article 120 of the EU Medical Device Regulation (MDR 2017/745) and Article 110 of the In Vitro Diagnostic Regulation (IVDR 2017/746), all medical devices that were validly CE-marked under the legacy directives (MDD (93/42/EEC), AIMDD (90/385/EEC), and IVDD (98/79/EC)) are required to be registered in the EUDAMED database by November 28, 2026.
EUDAMED (European Database on Medical Devices) is the EU-wide system for registering medical devices, economic operators, and certificates. It was originally designed as the single source of truth for all devices placed on the EU market. The November 2026 date is the final deadline in a series of phased rollouts, and it applies to the largest group: the legacy device portfolio still operating under pre-MDR/IVDR directives.
Missing this deadline is not a technical inconvenience. Devices not registered in EUDAMED by November 28, 2026 may no longer be legally placed on the EU market. For manufacturers with large legacy portfolios, the commercial risk is significant.
Who does this affect?
The obligation falls on multiple parties in the supply chain.
Manufacturers
The legal manufacturer is responsible for registering their devices and maintaining EUDAMED records. This includes non-EU manufacturers, who must register via their EU Authorised Representative.
Authorised Representatives
EU ARs must be registered in EUDAMED first, before any device registration can be linked to them. Non-EU manufacturers cannot register devices without a registered AR in place.
Importers
Importers placing CE-marked devices on the EU market must ensure EUDAMED registration is complete before distribution. They are not responsible for filing, but they carry compliance risk.
Device scope: what needs to be registered
What data does EUDAMED require?
EUDAMED's DTX schema requires up to 95 structured fields per device. Most of this data exists in your organisation, but rarely in the right format, in the right place, or mapped to the right field names. The preparation work is where manufacturers get stuck.
Device identity
- →Basic UDI-DI (grouping identifier)
- →Unit of Use UDI-DI
- →Device trade name
- →Device model/reference
- →EMDN classification code
Regulatory status
- →Applicable directive (MDD/AIMDD/IVDD)
- →Risk class
- →CE marking date
- →Notified Body number
- →Certificate reference and expiry
Technical characteristics
- →Intended purpose
- →Single use / reusable flag
- →Sterile / non-sterile
- →Measuring function
- →Implantable flag
Economic operator data
- →Manufacturer name and address
- →EU Authorised Representative (if applicable)
- →Importer details
- →SRN (Single Registration Number)
Recommended preparation timeline
Working backwards from November 28, 2026.
Audit your device portfolio. Identify which products are MDD/AIMDD/IVDD.
Export device data from ERP. Map columns to EUDAMED's 95-field schema.
Classify devices into EMDN codes. Validate Basic UDI-DI groupings.
Run full EUDAMED validation. Resolve Yellow and Red fields.
Generate clean validated CSV. Review and sign your Registration Decision Record.
Submit to EUDAMED. All legacy devices registered. Deadline met.
Common mistakes that cause rejections
EUDAMED validates submissions against a strict set of business rules. These are the most common reasons manufacturers face delays or rejections.
Wrong EMDN code
EUDAMED has 8,454 EMDN codes in a hierarchical tree. Using a parent code when a child code exists causes validation failure. Many devices are miscoded at too high a level.
Incorrect Basic UDI-DI grouping
Devices must be grouped by identical intended purpose, risk class, essential design, and manufacturing characteristics. Manufacturers often group too broadly or too narrowly.
Missing certificate references
MDR/IVDR devices require valid Notified Body certificate data in EUDAMED. MDD legacy devices still need the certificate that was current when CE marking was applied.
Wrong directive classification
A device CE-marked under MDD may need reclassification under MDR rules before registration. Getting the directive and risk class wrong blocks the entire submission.
Authorised Representative gaps
Non-EU manufacturers must register their EU Authorised Representative in EUDAMED before registering any devices. Many forget this dependency.
Treating it as a one-time task
EUDAMED registration is an ongoing obligation. Post-submission changes (new certificates, updated device descriptions) must be reflected within 30 days.
Not sure if your data is ready?
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