EUDAMED: First Four Modules Become Mandatory from 28 May 2026 — Regulatory Interpretation and Business Impact for Medical Device Manufacturers

Key Summary

The European Commission has announced that the first four EUDAMED modules — Actor Registration, UDI/Device Registration, Notified Bodies and Certificates, and Market Surveillance — have been mandatory since 28 May 2026. The measure is based on the transitional provisions of Regulation (EU) 2024/1860 and marks a new phase in the digitalisation of European medical device regulation. Manufacturers exporting to the EU, including Chinese manufacturers, should complete actor registration, update UDI information and verify certificate compliance promptly to avoid market access obstacles.

Complete Translated Core Content

EUDAMED — the European Database on Medical Devices

EUDAMED is the information system established under the Medical Devices Regulation (EU) 2017/745 and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746.

Since 28 May 2026, the following four EUDAMED modules have been mandatory:

• Actor registration
• UDI/Device registration
• Notified bodies and certificates
• Market surveillance

EUDAMED provides a dynamic view of the lifecycle of medical devices placed on the EU market. It integrates several electronic systems used to collect and process information on medical devices. EUDAMED aims to enhance overall transparency, including better access to information for the public and healthcare professionals, and to strengthen coordination among EU Member States.

Commission Implementing Regulation (EU) 2021/2078 of 26 November 2021 lays down the detailed arrangements required for the establishment and maintenance of EUDAMED.

Six modules and a public website

EUDAMED consists of six interconnected modules and a public website:

• Actor registration — mandatory since 28 May 2026
• UDI/Device registration — mandatory since 28 May 2026
• Notified bodies and certificates — mandatory since 28 May 2026
• Clinical investigations and performance studies — under analysis
• Vigilance and post-market surveillance — in development
• Market surveillance — mandatory since 28 May 2026; applicable to competent authorities and the European Commission

EUDAMED provides both restricted access and public access. The EUDAMED guidance documents should also be consulted.

What is the current implementation status?

Commission Decision (EU) 2025/2371 of 26 November 2025 on the functionality of certain electronic systems in EUDAMED and on the fulfilment of the corresponding functional specifications was published in the Official Journal of the European Union on 27 November 2025.

Under the transitional provisions laid down in Regulation (EU) 2024/1860, that publication triggered a six-month transition period. Consequently, the first four modules have been mandatory since 28 May 2026:

• Actor registration — available on a voluntary basis since December 2020
• UDI/Device registration — voluntary since October 2021
• Notified bodies and certificates — voluntary since October 2021, with the exception of the scrutiny mechanism and the clinical evaluation consultation procedure (CECP) functionality
• Market surveillance

The remaining two modules — post-market surveillance and vigilance, and clinical investigations and performance studies — are still under development and will be released when they become mandatory. No voluntary use period is foreseen for these two modules before their mandatory application.

EUDAMED timeline and transition periods

The Commission has published a Q&A on practical aspects of the progressive roll-out of EUDAMED under Regulation (EU) 2024/1860, together with a summary timeline of transition periods for devices and certificates. These cover the six-month transition period, registration of legacy and regulation devices placed on the market before the mandatory application date, and the registration of certificates.

Latest updates — news announcements

• 16 June 2026 — Upcoming webinar on the new EUDAMED SS(C)P functionality, 2 July 2026, 13:00–17:00 CEST
• 1 June 2026 — The first four EUDAMED modules mandatory since 28 May 2026
• 14 April 2026 — Upcoming full-day EUDAMED training livestream
• 18 March 2026 — Recording available: Commissioner Várhelyi opened the high-level medical devices event

AIMEILI Regulatory Interpretation

What does this information mean for medical device companies?

When the European Commission publishes an update of this kind, companies should first classify it — whether it concerns regulatory policy, guidance and standards, recall and safety, product performance, quality systems or post-market oversight. Each category affects registration pathways, technical documentation, labelling and instructions for use, risk management and market maintenance differently and should not be treated as general industry news.

For manufacturers, the priority is to convert the announcement into executable compliance actions: confirm whether similar products, similar technology routes or similar risk profiles are affected; verify whether existing documentation still supports the requirements of the target market; and, where necessary, update risk management, performance verification, clinical evaluation, labelling and instructions for use, distributor communications and post-market surveillance records.

Which documents should be reviewed first?

• Intended use and classification rationale
• ISO 13485 quality management system certification
• Risk management file
• Performance verification and validation data
• Clinical evaluation or clinical evidence
• Labelling and instructions for use
• Authorisation documents and existing registration certificates

Common risks

Common risks include unclear classification decisions, an incomplete evidence chain, non-localised labelling and instructions for use, unclear responsibilities of the authorised representative, and insufficient post-market maintenance arrangements.

Business Impact on EU Market Access

Actor registration and the SRN

The actor registration module requires all economic operators — manufacturers, importers, authorised representatives and system or procedure pack producers — to register in EUDAMED and obtain a Single Registration Number (SRN). A manufacturer that has not completed actor registration cannot lawfully place devices on the EU market. Companies should immediately verify the status of their SRN application and ensure that the registration process is compliant before and after the transition period.

UDI/Device registration

With the UDI/Device registration module now mandatory, every medical device placed on the EU market must be assigned a UDI-DI and registered in EUDAMED. Manufacturers must ensure compliance with UDI coding rules and prepare UDI carriers, such as barcodes or 2D codes, together with the associated labelling updates in advance. Because this module affects technical documentation, packaging and labelling, and involves significant cost, a phased approach prioritising high-priority products is advisable.

Notified bodies and certificates

With the Notified Bodies and Certificates module mandatory, all MDR and IVDR certificate information must be entered into EUDAMED by the notified body. Manufacturers should confirm with their notified body the progress of certificate uploads, since missing information may result in a certificate being treated as invalid. For legacy devices covered by MDD or AIMDD certificates, the transitional provisions allow continued placing on the market under specific conditions, but correct registration in EUDAMED is required; otherwise compliance risk may arise.

Market surveillance

The mandatory market surveillance module gives competent authorities in the Member States the ability to conduct market surveillance through EUDAMED. Manufacturers must maintain a robust post-market surveillance system and report serious incidents and field safety corrective actions in a timely manner. The module facilitates regulatory information sharing but also increases the likelihood of cross-border scrutiny. Companies are advised to establish a dedicated EUDAMED compliance function, track module updates and participate in training webinars organised by the European Commission.

Overall positioning

The mandatory application of EUDAMED marks the comprehensive digitalisation of EU medical device regulation. Manufacturers should treat it as a mandatory step for market access rather than an optional compliance item. Technical documentation, labelling, quality systems and registration strategy should be adjusted in parallel, with SRN and UDI registration prioritised, and close communication maintained with notified bodies and importers. The future mandatory application of the two remaining modules — vigilance and clinical investigations — will bring further impact and should be monitored continuously.

Documentation consistency and evidence-chain management

From an international registration practice perspective, the direct impact is usually felt in documentation consistency and evidence-chain management. Companies should check existing technical files, risk management reports, performance verification data, clinical evaluation or clinical evidence, labelling and instructions for use, quality system certificates and post-market surveillance documentation to confirm whether they still support the latest regulatory expectations of the target market. Where the update concerns safety notices, recalls, product approvals or regulatory meetings, companies should also assess whether similar products, technology routes or risk profiles are likely to receive heightened scrutiny from reviewers.

For companies pursuing multi-country registration, particular attention should be paid to the boundaries of document reuse: the same CE, FDA, NMPA, ISO 13485 or MDSAP documentation may serve as core evidence in one market while requiring localised explanations, translated labelling, authorised representative documentation or a post-market maintenance plan in another. A short documentation gap review after each significant regulatory update helps avoid difficulties during deficiency response, change notification or certificate renewal.

Recommended Actions

• Record the official source link, publication date, applicable product scope and potentially affected areas in the regulatory tracking log.
• Have regulatory affairs, quality, R&D and sales jointly determine whether labelling, instructions for use, clinical evaluation, risk management or test reports require updating.
• Where products are already on the market or applications have been submitted, assess in parallel whether the authorised representative, importers, distributors and after-sales teams need to communicate, file changes, provide supplementary explanations or take post-market surveillance measures.

FAQ

Can the announcement that four EUDAMED modules are mandatory from 28 May 2026 be used directly as a basis for regulatory submissions?

No. This article is intended for preliminary understanding and project assessment only. Formal submissions must be based on the latest requirements of the regulatory authority in the target country, the concluded product classification and the company's actual documentation status.

What should a company do first after seeing this update?

A documentation gap assessment should be carried out first, to confirm whether the update affects the registration pathway, technical documentation, labelling, quality system or post-market maintenance obligations.

Source and Scope

Source: European Commission, Medical Devices — EUDAMED (https://health.ec.europa.eu/medical-devices-eudamed/overview_en). Original date: 28 May 2026. Specific requirements remain subject to the latest official publications of the regulatory authorities. This article supports preliminary understanding, documentation preparation and project planning and does not replace the formal requirements of the target country's regulatory authority, testing conclusions or legal advice.

Need to assess a registration pathway? Provide the product name, intended use, target markets and existing documentation base, and AIMEILI can help determine the registration route, documentation gaps and compliance risks.