{"id":27851,"date":"2026-02-17T09:05:43","date_gmt":"2026-02-17T08:05:43","guid":{"rendered":"https:\/\/www.chemsafe-consulting.com\/?p=27851"},"modified":"2026-06-23T09:27:55","modified_gmt":"2026-06-23T07:27:55","slug":"eudamed-mandatory-modules-may-2026","status":"publish","type":"post","link":"https:\/\/www.chemsafe-consulting.com\/it\/blog\/eudamed-mandatory-modules-may-2026\/","title":{"rendered":"EUDAMED is Now Mandatory: What has changed since May 2026"},"content":{"rendered":"

The European Database on Medical Devices, a key element of the European Union\u2019s regulatory framework for medical devices <\/strong>– introduced under Regulation (EU) 2017\/745 (MDR)<\/a><\/strong> and Regulation (EU) 2017\/746 (IVDR), is designed for enhancing transparency<\/strong>, traceability, and coordination among economic operators, notified bodies, competent authorities, and the public.<\/p>\n

EUDAMED is structured into different interconnected modules<\/strong>, each designed to collect and manage regulatory information throughout the lifecycle<\/strong> of medical devices and in vitro diagnostic devices. These modules allow stakeholders to submit, access, and exchange data related to devices, manufacturers<\/strong>, certificates, vigilance, and market surveillance activities.<\/p>\n

After years <\/strong>of delays, phased roolouts, and industry-wide anticipation, EUDAMED <\/strong>has finally become mandatory<\/strong>. As of May 28, 2026 the\u00a0 first four EUDAMED modules have been implemented for economic operators placing medical devices and in vitro diagnostic devices on the European market.
\nFor manufacturers, importers, and other stakeholders, this is more than just another regulatory requirement.
\nIt marks a significant shift toward greater transparency, traceability, and regulatory oversight across the entire device lifecycle.<\/p>\n

EUDAMED Modules: How do they work?<\/strong><\/h2>\n

EUDAMED is divided into six modules and each module focuses on a specific matter:<\/p>\n

    \n
  1. Actor Registration Module<\/span>
    \n<\/strong>This module enables economic operators, including manufacturers, authorized representatives, and importers, to register and obtain a Single Registration Number <\/strong>(SRN)<\/span>.Without a valid SRN, companies cannot fulfil several key MDR and IVDR obligations.
    \n<\/strong><\/li>\n
  2. UDI\/Device Registration Module<\/span>
    \n<\/strong>This module collects detailed information<\/strong> about devices placed on the EU market<\/strong>, including Unique Device Identification <\/strong>(UDI)<\/span> data. It supports device traceability, transparency, and improved post-market monitoring.
    \nFor many organizations this represents the most resource-intensive aspect<\/span> of EUDAMED compliance<\/strong>.Common challanges include:
    \n\u2022 Incomplete product data.
    \n\u2022 Tenuous UDI records.
    \n\u2022 Misalignment<\/span> between technical documentation and registration data.
    \n\u2022 Difficulties managing<\/span> UDI-DI Information<\/span>.<\/p>\n

    Companies that have not yet established robust UDI data management processes may face significant implementation challenges.<\/li>\n

  3. Notified Bodies and Certificates Module<\/span>
    \n<\/strong>This module contains information about notified bodies<\/span> designated under MDR\/IVDR<\/strong> and the certificates they issue, suspend, withdraw, or restrict.
    \nIts purpose is to provide greater transparency<\/span> regarding decive certification status and regulatory compliance.
    \n<\/strong><\/li>\n
  4. Clinical Investigations and Performance Studies Module<\/span>
    \n<\/strong>It manages applications, approvals, and monitoring<\/span> of clinical investigations<\/strong> and performance studies conducted in the EU.
    \n<\/strong><\/li>\n
  5. Vigilance and Post-Market Surveillance Module<\/span>
    \n<\/strong>This module enables reporting and monitoring<\/strong> of serious accidents<\/strong>, field safety corrective actions (FSCAs), and trend reporting.
    \n<\/strong><\/li>\n
  6. Market Surveillance Module<\/span>
    \n<\/strong>It facilitates cooperation among competent authorities<\/span> regarding market surveillance activities, including non-compliant devices and the implementation of corrective measures.
    \nThe coordinated market surveillance activities across the European Union contributes to faster identification of non-compliant devices<\/span> and more efficient implementation of corrective actions.<\/li>\n<\/ol>\n

    Mandatory Modules for Manufacturers<\/strong><\/h2>\n

    The first four modules have been mandatory since May 28, 2026<\/strong>, following\u00a0Decision (EU) 2025\/2371<\/a>, published on November 27, 2025.
    \nManufacturers need to store data in the EUDAMED and be compliant with the following modules:<\/p>\n