Did every EUDAMED module become mandatory on 28 May 2026?

No. Mandatory use began for the first four modules. Check separate official schedules for vigilance/PMS and clinical investigations/performance studies.

Is 28 November 2026 the registration deadline for every device?

No. First placing on the market, continued supply under the same identifier and regulatory status matter. For new Regulation devices, consider the requirement for registration before first placing on the market separately.

EUDAMED 2026: Device Registration Readiness Guide

Cover image for: EUDAMED 2026: Mandatory Modules, Device Registration and the November Transition — Photo: Gabriela P. · License: CC BY 4.0 · Cropped and resized.

Published: 27 October 2026
Updated: 27 October 2026
Sources checked: 27 October 2026

EUDAMED's first four modules became mandatory on 28 May 2026. This does not mean that every module is available or every device has the same registration deadline. As of 27 October 2026, manufacturers should map their portfolios to the correct transition scenarios and check registration evidence. This guide provides an official-source decision framework and practical review recommendations for teams placing devices on the EU market.

Which EUDAMED modules became mandatory on 28 May 2026?

The European Commission explains that Decision (EU) 2025/2371 declaring the functionality of four modules was published on 27 November 2025, with mandatory use following a six-month transition. The scope covers actor registration, UDI/device registration, notified bodies and certificates, and market surveillance. Market surveillance is for competent authorities and the Commission; manufacturers should not assume they perform the same activity in every module.

Vigilance/post-market surveillance and clinical investigations/performance studies follow separate implementation schedules. Do not automatically apply the first four modules' date to these two. Check the official functionality notice and transition provisions for the relevant module when planning a new obligation; a development target is not a confirmed effective date.

28 November 2026 does not mean the same thing for every device

The Commission's transition infographic and gradual rollout Q&A identify scenarios based on first placing on the market. Here, a Regulation device means a device conforming to MDR/IVDR requirements, while a legacy device benefits from the relevant transitional provisions. A catalogue listing does not establish the correct deadline. Use records to establish when the first unit under the same device identifier was placed on the market and whether further units continue to be placed.

For a Regulation device whose first unit will be placed on the EU market on or after 28 May 2026, complete the relevant registration before that first unit is placed on the market.
Assess the 28 November 2026 transition deadline for relevant legacy/Regulation devices whose first unit preceded mandatory use and whose additional units under the same identifier continue to be placed on the market afterward.
Review devices with no further units being placed on the market, legacy devices linked to the same Regulation device and other exceptions separately; do not apply one date to the entire portfolio.

Verify the actor, SRN and authorised representative chain

Actor registration establishes the economic operator's Actor ID/SRN identity. For a manufacturer outside the EU, an active authorised representative and the summary mandate document are important. The Commission's actor page also describes the signed declaration concerning information security responsibilities. Registering an organisation and authorising an individual user to act for it are separate checks.

Compare legal name, address, operator role and representative information with source documents.
Track whether the registration request is a draft, submitted, validated or approved.
Identify the request preparer, organisation administrator and deputy responsible for maintaining the record.
Do not interpret appointing a consultant as removing the manufacturer's responsibilities for data accuracy.

Make product data consistent before UDI registration

Select the UDI/device registration dataset according to MDR or IVDR scope and the device's transition status. The Commission publishes datasets for different device groups; EMDN is the nomenclature used for device registration. Do not manage Basic UDI-DI, UDI-DI, product reference and device status as interchangeable labels.

As an operational recommendation, compare samples across labelling, technical documentation and the product master-data table before uploading. Identify the documents and records affected by a changed field. For bulk uploads, track accepted rows separately from failed rows; transferring a file does not prove every registration is complete. Retain traceable corrections in the source data.

Do not describe EUDAMED registration as device approval

The Commission's user guidance explains that device registration does not involve assessment, review or approval by a competent authority. Do not present a registration output as a safety approval or proof that all regulatory conditions are met. Acceptance of information by the system does not establish that every use of it is compliant.

In an evidence package shared with a sponsor, distributor or procurement team, identify the registration, scope checked and date of review. Keep certification, clinical evidence, placing-on-market status and completed registration as separate topics. This reduces the risk of commercial teams turning a technical registration status into an unsupported conformity claim.

Close portfolio actions against ownership and evidence

In the first screening, show the applicable scenario, supporting source, registration status, owner and open question for each product row. Prioritise more than the nearest date: consider the placing-on-market plan, missing actor dependencies and the impact of data errors. Do not assume a product-family decision applies to every variant.

Use the same portfolio table across regulatory affairs, product master data, quality and commercial operations.
Identify the correction owner, internal review date and completion evidence for every open activity.
Define who monitors post-registration changes and when records will be reviewed again.
Send ambiguous products to a separate specialist assessment queue; do not mark an unknown status as compliant.

Frequently asked questions

Did every EUDAMED module become mandatory on 28 May 2026?: No. Mandatory use began for the first four modules. Check separate official schedules for vigilance/PMS and clinical investigations/performance studies.
Is 28 November 2026 the registration deadline for every device?: No. First placing on the market, continued supply under the same identifier and regulatory status matter. For new Regulation devices, consider the requirement for registration before first placing on the market separately.
Does EUDAMED device registration replace authority approval?: No. According to the Commission's user guidance, device registration does not involve assessment, review or approval by a competent authority.