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Term of the Day

Natural history study

A natural history study is a preplanned observational study intended to track the course of a disease over time, identifying demographic, genetic, environmental and other variables that correlate with its development and outcomes in the absence of intervention, or under standard of care. Designs may be retrospective (chart review of existing records) or prospective (longitudinal follow-up of a cohort or registry).

Natural history data is particularly important in rare and paediatric diseases, where randomised placebo-controlled trials may be infeasible or unethical. The FDA (guidance on rare disease natural history studies, 2019) and the EMA accept well-designed natural history studies to define endpoints and biomarkers, identify patient subgroups, estimate sample sizes and, in some cases, serve as external or historical control arms for single-arm trials supporting orphan products.

Because they are non-interventional, natural history studies fall outside the CTR and are governed by national law (for example France's MR-003 or MR-004 reference methodologies) and by the GDPR. They typically involve secondary use of medical records, long-term follow-up, genetic data and small populations in which anonymisation is rarely achievable, so pseudonymisation, a DPIA and a robust research legal basis under Art. 9(2)(j) are essential. Registries maintained by patient organisations or academic consortia raise additional questions of joint controllership and data access governance.

E

EUDAMED

EUDAMED is the European Database on Medical Devices, an information system supporting the EU medical device and in vitro diagnostic frameworks. It connects information about economic operators, devices, certificates and regulatory oversight. Public access and restricted regulatory functions coexist, so not all information is visible to everyone.

Key Takeaways

  • EUDAMED has six interconnected modules, with different users, functions and implementation stages.
  • Four modules became mandatory on 28 May 2026, including market surveillance for competent authorities and the Commission.
  • Manufacturers should check device-specific transition rules rather than assuming every existing record had the same registration deadline.

Which EUDAMED Modules Are Operational?

ElementMeaning
Actors; UDI/devicesMandatory modules since 28 May 2026
Notified bodies/certificates; market surveillanceMandatory modules since 28 May 2026
Clinical investigations; vigilance/PMSSeparate implementation stages

The European Commission identifies actor registration, UDI/device registration, notified bodies and certificates, and market surveillance as the first mandatory modules. Its overview distinguishes these from clinical investigations/performance studies and vigilance/post-market surveillance. The system includes both public and restricted access. Always confirm the current module instructions and transitional provisions before preparing an upload; the start of mandatory module use is not the same as a single deadline for all historical devices.

Primary guidance: European Commission EUDAMED overview; FAMHP transition clarification.

Why It Matters for Data Protection

For a hypothetical diagnostic manufacturer, we recommend separating the regulatory registration owner from the person approving personal information for disclosure. Review contact details, certificates and attached documents before upload, particularly where a document prepared for a restricted audience may enter a public workflow. Maintain an internal record of the submitted version and correction process. A useful control is a two-person check of the destination, module and visibility level, rather than assuming that an authenticated portal guarantees confidentiality.

Frequently Asked Questions

Is all EUDAMED information public?

No. The system has public and restricted functions.

Is EUDAMED itself a device approval?

No. Database registration is distinct from conformity assessment and other regulatory obligations.

Are all six modules mandatory now?

No. Check the Commission’s current module status and applicable transitional rules.

Related reading: medical device regulation mdr; in vitro diagnostic regulation ivdr.

Explore iliomad’s medical devices support for your organisation.

Updated: 27 October 2026