The November 2026 EUDAMED Deadline

DEADLINE

November 28, 2026 is the final registration deadline for existing devices under the derogation granted by Commission Decision (EU) 2025/2371. After this date, devices without a valid EUDAMED record have no legal basis for continued sale in the EU.

What Changed

EUDAMED, the European database on medical devices, was always designed to become mandatory. The legal basis is MDR Article 34(1), which required the European Commission to establish a European database on medical devices. Both MDR 2017/745 and IVDR 2017/746 called for a phased rollout, module by module, with the deployment schedule governed by Regulation (EU) 2024/1860. The system has been accepting live submissions since 2021. What changed in late 2025 was the formal closure of the last extension window.

Commission Decision (EU) 2025/2371, published November 27, 2025, confirmed that no further derogations would be granted for mandatory EUDAMED registration. Full mandatory operation began May 28, 2026. A single derogation remained: devices already on the market with valid conformity certificates could continue commercial distribution until November 28, 2026, provided registration was completed by that date.

The May date applies to any device entering the EU market for the first time after that date. Those devices must be registered in EUDAMED before first placement. The November date is the hard stop for everything already in distribution channels.

For IVDR-regulated in vitro diagnostic devices, compliance timelines are staggered by risk class under Regulation (EU) 2024/1860. Class D devices (highest-risk IVDs) carry the earliest obligations, with lower risk classes extending through 2029. IVDR-regulated manufacturers should confirm which class-specific deadline applies to each product in their portfolio.

Who Must Register

Registration obligations run along operator type, not product category. The framework applies differently to manufacturers, Authorised Representatives, and importers.

Manufacturers

Any manufacturer placing a device on the EU market must register both an actor record (their own company details) and a device record (the specific product) in EUDAMED. This obligation applies equally to manufacturers established in the EU and those outside the EU who operate through an Authorised Representative. The responsibility sits with the legal manufacturer, not with distributors or resellers.

Authorised Representatives

Non-EU manufacturers must have an EU Authorised Representative with an active EUDAMED actor record before any device registration can proceed. The AR record must be confirmed active and linked to the manufacturer's record. If the AR record is not yet in place, that dependency resolves before device data preparation is useful.

Importers

Importers register separately as economic operators under MDR Article 13. They are not responsible for device registration itself, but their own operator record must be current in the system. Importers who have not yet registered face penalties from national competent authorities independent of whether the manufacturer has completed device registration.

Clinical investigation and performance study sponsors

Sponsors of clinical investigations under MDR Article 62 and sponsors of performance studies under IVDR must register as actors in EUDAMED before initiating investigations. The actor record establishes a Single Registration Number that must appear in the investigation notification submitted to national competent authorities.

System and procedure pack producers

Economic operators who combine devices into systems or procedure packs under MDR Article 22 must register as actors in EUDAMED independently. Their registration obligation is separate from the manufacturer records for the component devices included in the system or procedure pack.

Scope exclusions

Custom-made devices and investigational devices follow separate registration pathways and are not subject to the mass-registration EUDAMED workflow. Class I devices placed on the market under the old MDD Annex VII self-declaration route are out of scope for certain device-level obligations but still require actor registration.

NOTE

EUDAMED uses a role-based access model. Manufacturer, Authorised Representative, and importer records are independent entries that get linked at the device level. A manufacturer and their AR each register separately before device records can be created.

Data Requirements

EUDAMED registration is a data submission problem. The system accepts structured input across the Actor, UDI/Device, and Certificate modules. The full mandatory field set runs to 95+ fields depending on device class, risk classification, and whether the product is an active implantable, SaMD, or contains materials of human or animal origin.

Mandatory fields for every device record

UDI-DI: the Device Identifier assigned through a Commission-recognized issuing entity (GS1, HIBCC, or ICCBBA)
Basic UDI-DI: the grouping identifier referencing the EU Declaration of Conformity
EMDN code: one terminal-level code from the European Medical Device Nomenclature
Risk classification: derived under MDR Annex VIII or IVDR Annex VIII, not MDD rules
Trade name and model/version: exactly as it appears on the device label
Manufacturer SRN: the Single Registration Number from a completed actor registration
Certificate number and NB code: required for Class IIa, IIb, III (MDR) and Class B, C, D (IVDR)
Country of origin: ISO 3166-1 alpha-2 code, mandatory for all devices

Additional requirements by device class

Higher-risk devices add fields: clinical investigation references, implantable device flags, human tissue or cell flags, system and procedure pack designations, and for SaMD, the software lifecycle documentation references. The EUDAMED data dictionary, published by the European Commission, lists the complete field-by-field requirement matrix.

WARNING

EUDAMED performs field-level validation at submission. A missing required field returns a hard rejection, not a warning. The record cannot be partially saved and corrected in the same pass. Your data must be complete before the submission attempt.

Legacy Device Rules

Devices certified under the predecessor frameworks (MDD 93/42/EEC, AIMDD 90/385/EEC, and IVDD 98/79/EC) operate under specific transition rules that differ from full MDR/IVDR obligations. The distinction matters for what data you need to prepare now versus later.

What legacy-certified devices must do

Under MDR Article 120 and the transition provisions extended by Regulation (EU) 2023/607, devices still on the market under valid MDD/AIMDD certificates must:

Complete actor registration in EUDAMED (manufacturer and AR if applicable)
Register in EUDAMED for vigilance reporting: incident reports and field safety corrective actions must flow through the system
Obtain and use a UDI-DI if the device is Class IIa or above

What legacy-certified devices are not yet required to do

Legacy devices with a valid MDD/AIMDD certificate do not need to complete the full MDR/IVDR device registration record. The obligation to submit the complete dataset (EMDN codes, certificate cross-references under MDR, all 95+ fields) applies when the device transitions to an MDR/IVDR certificate, not while the old certificate remains valid.

Once a legacy certificate expires or is withdrawn, the device must either carry a valid MDR/IVDR certificate or leave the EU market. There is no indefinite grandfathering.

DEADLINE

MDD/AIMDD certificate holders who have not yet started their MDR transition face a hard choice at November 28, 2026. Certificates expiring after that date without an MDR conformity assessment in progress leave no legal pathway for continued EU sales.

Common Mistakes

Mistake	What Actually Happens	Prevention
Wrong UDI-DI level submitted	Device record created but linked to the wrong certificate or DoC level, requiring correction before review	Confirm Basic UDI-DI and Unit of Use DI with the issuing entity before preparing any data
EMDN code at category level, not terminal	Submission accepted by EUDAMED but flagged during NB review; correction required before certificate is valid	Always select a terminal (leaf-node) code. Category codes have child entries in the EMDN browser.
Manufacturer SRN not yet confirmed active	Device registration fails immediately with actor record not found error	Verify actor registration status before building any device dataset
Certificate number taken from internal tracking, not source document	EUDAMED cross-check against the certificate module fails; record flagged as non-compliant	Pull certificate numbers directly from the NB-issued certificate PDF
Risk classification using MDD Annex IX rules	Class assignment incorrect under MDR Annex VIII; rejected during NB conformity review	Reclassify every device under current MDR/IVDR rules, even if the intended class is the same

Preparation Checklist

Registration in EUDAMED is a data problem before it is a system problem. Most submission failures trace back to incomplete or incorrectly formatted input, not to the database itself. The following checklist covers the inputs that cause the most rejections.

Before you touch EUDAMED

Confirm each device's Basic UDI-DI with the issuing entity (GS1, HIBCC, or ICCBBA)
Resolve every device's EMDN code to a terminal node
Verify the manufacturer actor record is active and has a confirmed SRN
If non-EU, confirm the Authorised Representative actor record is active and linked
Pull every certificate number from source documents, not from internal spreadsheets
Reclassify all devices under MDR Annex VIII or IVDR Annex VIII rules
Identify any devices with implantable, active, SaMD, or biological material flags

Data formatting requirements

Trade names: match the device label exactly, including capitalization and punctuation
Dates: ISO 8601 format (YYYY-MM-DD) throughout the dataset
Country codes: ISO 3166-1 alpha-2 only
Language codes: BCP 47 format (e.g., en-GB, de-DE)
EMDN codes: full hierarchical code string, not just the terminal segment

TIP

Running a dry submission against the EUDAMED sandbox environment catches field-level errors before they affect your live record. The sandbox is available at the same portal as the production system. Use it with test data before submitting real device records.

The November 2026 deadline is fixed at the Commission level. National competent authorities can take market withdrawal action against devices without a valid EUDAMED record once the derogation expires. If your data is not clean and structured today, the window for fixing it is shrinking.