Eudamed, an database in EU for century

EUDAMED overview

EUDAMED is the European database for medical devices and in vitro diagnostic devices established under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). It centralizes regulatory information about devices and the economic operators who place them on the EU market. Who must register: manufacturers, authorised representatives, importers, system and procedure pack producers, and other economic operators involved in placing devices on the EU market.

EUDAMED structure and modules

EUDAMED is organised as six interconnected modules plus a public-facing website:

Actor registration — registration of economic operators and their roles. (deadline May 28, 2026)

UDI / Device registration — unique device identifiers and device records. (deadline May 28, 2026)

Notified Bodies and Certificates — information on conformity assessment bodies and issued certificates. (deadline May 28, 2026)

Clinical Investigations and Performance Studies — records of clinical investigations and performance studies. (deadline May 28, 2026)

Vigilance and Post‑market Surveillance — incident reporting, field safety corrective actions, and PMS activities.

Market Surveillance — information used by competent authorities to monitor compliance and take action.

Key differences compared with typical FDA and NMPA databases

Integrated modular design: EUDAMED groups all regulatory functions into six linked modules; FDA and NMPA information is spread across multiple, often separate public registries and reporting systems.

Vigilance and PMS integration: EUDAMED includes a dedicated vigilance and post‑market surveillance module that is tightly connected to device and actor records; FDA uses separate adverse‑event systems (e.g., MAUDE) that are less tightly coupled.

Market surveillance focus: EUDAMED explicitly supports market surveillance workflows for competent authorities; comparable functions in FDA and NMPA are implemented across different agencies and datasets.

Search and discoverability limitations: EUDAMED currently offers limited ways to search by clinical product code or to flag innovative products, making it harder to locate devices by therapeutic area or novelty compared with some FDA datasets.

Governance and verification: The process for verification and cross‑checking of submitted information in EUDAMED is less transparent to stakeholders than the more established publication and approval trails used by FDA and NMPA.

Practical challenges observed

Role concentration: Many foreign manufacturers rely on a single EU distributor to act as authorised representative, importer, and distributor. This multi‑role setup creates risks for maintaining accurate, up‑to‑date EUDAMED records.

Data readiness: Keeping regulatory information current in EUDAMED is operationally demanding, especially when responsibilities are split across organisations.

Search limitations: It can be difficult to locate devices by clinical product code (for example cardiovascular categories) or to identify truly innovative products within EUDAMED.

Governance and verification: It is not always clear how the European Commission and Member State competent authorities verify and validate the information submitted, or how automated acceptance rules are defined.

Recommendations and strategic suggestions

For manufacturers and distributors: avoid over‑consolidating roles in a single distributor where possible; define clear contractual responsibilities and designate a responsible EUDAMED administrator.

For authorities and the European Commission: publish clearer templates and machine‑readable schemas for the data EUDAMED accepts, and clarify verification workflows between the Commission, Member States, and notified bodies.

For stakeholders: establish standardised product coding or tagging for innovative devices to improve discoverability and regulatory traceability within EUDAMED.

Services we can provide

Outsourced EUDAMED administration: act as a dedicated user administrator on behalf of foreign manufacturers to manage actor registration, device records, UDI entries, and certificate tracking.
Role management and readiness: maintain up‑to‑date contact and role information for EU authorised representatives, importers, and distributors to reduce regulatory gaps.

Vigilance and PMS support: help prepare and submit vigilance reports and post‑market surveillance data in the required formats.

Data hygiene and monitoring: regular audits of EUDAMED entries to ensure consistency across modules and readiness for inspections or market surveillance actions.

EUDAMED 是欧盟为 MDR/IVDR 建立的集中数据库，要求制造商、授权代表、进口商和分销商等在欧盟市场上相关的经济主体进行注册并维护信息。

我们可提供的支持

角色梳理与授权书模板：明确谁负责 EUDAMED 的哪一模块并签署书面授权。

账号与演员注册代办：为制造商或其欧盟代表创建并维护用户管理员账号，定期更新联系人与职责。

UDI/器械登记与证书关联：整理技术资料、UDI 数据并在 EUDAMED 中建立设备记录，关联已发证书与通告。

警戒与上市后监测支持：协助准备不良事件报告、召回与 PMS 文档并按要求提交。