---
title: EUDAMED Clinical Investigation Module: Registration Requirements
description: The EUDAMED clinical investigation module registers studies, sponsors, and outcomes. Here is what it requires and when the obligation applies.
authors: Tibor Zechmeister, Felix Lenhard
category: EUDAMED, UDI & Registration
primary_keyword: EUDAMED clinical investigation module
canonical_url: https://zechmeister-solutions.com/en/blog/eudamed-clinical-investigation-module
source: zechmeister-solutions.com
license: All rights reserved. Content may be cited with attribution and a link to the canonical URL.
---

# EUDAMED Clinical Investigation Module: Registration Requirements

*By Tibor Zechmeister (EU MDR Expert, Notified Body Lead Auditor) and Felix Lenhard.*

> **The EUDAMED clinical investigation module is the fourth of the six EUDAMED modules established under MDR Article 33. It holds sponsor applications, clinical investigation plans, summaries, notifications of serious adverse events and device deficiencies, and the final clinical investigation reports for studies conducted under MDR Articles 62 to 82 and Annex XV. Its central legal feature is the single-submission mechanism in MDR Article 73: once that provision applies, a sponsor running a clinical investigation across several Member States submits a single application through EUDAMED, and that single submission reaches every concerned Member State. Mandatory use of the module is tied to the Article 34 functional-declaration mechanism, and until the Commission declares the module functional and the transitional period ends, national application and notification procedures remain in force in parallel.**

**By Tibor Zechmeister and Felix Lenhard. Last updated 10 April 2026.**

---

## TL;DR

- The EUDAMED clinical investigation module is the electronic system for clinical investigations required by MDR Article 73 and referenced throughout Articles 62 to 82 and Annex XV.
- MDR Article 73 establishes a single-submission route: one sponsor application, filed once through EUDAMED, reaches every Member State in which the investigation is planned.
- The module captures sponsor identity, the clinical investigation plan required by Annex XV, the investigator's brochure, ethics and competent authority decisions, serious adverse event and device deficiency reports under Article 80, and the clinical investigation report required by Article 77.
- Sponsor obligations under MDR Article 72 do not shrink because a small startup is the sponsor. They are the same obligations a multinational carries, executed through the same system.
- Mandatory use is governed by MDR Article 34. Until the Commission declares this specific module functional and the transitional period ends, national procedures under Articles 70, 74, and 78 continue to apply.
- Parts of the module feed the public EUDAMED transparency layer. Summaries of clinical investigations become visible through the public side of the database, by design of MDR Article 33(2).

---

## A founder opens Article 73 for the first time

A founder working on a Class IIb device reads MDR Article 62 and understands that a clinical investigation is on the project plan. They keep reading. Article 70 talks about applications to Member States. Article 73 talks about an electronic system and a single submission. Article 74 talks about investigations using already CE-marked devices within their intended purpose. Article 78 talks about a coordinated assessment procedure. Somewhere in the middle they stop and ask the question every sponsor eventually asks: am I submitting this to a national authority, to EUDAMED, to an ethics committee, or to all three. And in what order?

This post answers that question for the EUDAMED side specifically. It covers what the clinical investigation module does, what Article 73 means by "single submission," what data actually lives in the module, what the sponsor is responsible for, and what the public transparency layer exposes. The clinical investigation itself. Whether you need one, when exemptions apply, how to run one on a startup budget. Is covered in the cluster pillar, [what is a clinical investigation under MDR](/blog/what-is-clinical-investigation-mdr), and in the deep-dive posts linked at the end.

## What the module does

The EUDAMED clinical investigation module is one of the six modules described in [the EUDAMED pillar post](/blog/what-is-eudamed-european-database-medical-devices). It exists because MDR Article 73 requires an "electronic system on clinical investigations" to be set up, managed, and maintained by the Commission as part of EUDAMED. The purpose of that system, read together with Article 33(2), is to handle the regulatory workflow of clinical investigations electronically and to support the transparency objectives of the Regulation for clinical research on devices.

The module serves three functions at once. First, it is a workflow tool: sponsors file applications, receive Member State decisions, and report events through it. Second, it is a recordkeeping system: the clinical investigation plan, the investigator's brochure, and the final report are stored in it. Third, it is a public-transparency surface: parts of the data are made accessible to the public in line with Article 33(2), including summaries of investigations and their outcomes.

Read against Articles 62, 70, 71, 72, 73, 74, 75, 77, 78, and 80. The main substantive provisions on clinical investigations. The module is the electronic backbone that those articles assume exists. Annex XV specifies, in detail, the content of the clinical investigation plan, the investigator's brochure, and the reporting requirements that flow through it.

## The Article 73 single-submission concept

The most important legal feature of the module is the single-submission mechanism for multi-Member-State investigations. It sits in MDR Article 73 and the surrounding provisions on coordinated assessment.

Before the MDR, a sponsor running a clinical investigation of a medical device in several EU countries had to file a separate application in each one, each with its own national forms, its own language requirements, and its own administrative cycle. The MDR replaces that pattern with a single electronic submission. Under the scheme contemplated by Articles 73 and 78, a sponsor who intends to run an investigation across multiple Member States files one application via the EUDAMED clinical investigation module. The application is then distributed to each concerned Member State, and the assessment is coordinated between them.

The single submission does not remove national competence. Each concerned Member State still has a role in authorising or refusing the investigation on its territory, and ethics committee review remains a national procedure governed by national law. What changes is the administrative entry point and the coordination layer on top of it. One file, one submission, one reference. The substantive assessment stays with the authorities that are responsible for it under MDR and under national procedure.

Two points matter for a founder planning their first investigation. First, the single-submission mechanism is only one piece of the picture. Ethics committee approval is required in every Member State where the investigation runs, and that approval is obtained through national ethics procedures, not through EUDAMED. Second, mandatory use of the single-submission route depends on the module being declared functional under MDR Article 34. Until the Commission publishes the functional declaration and the transitional period for this specific module ends, the national application and notification routes under MDR Articles 70 and 74 continue to apply in parallel.

## What data the module captures

The data captured by the EUDAMED clinical investigation module reflects the substantive requirements of MDR Articles 62 to 82 and Annex XV. The list below is the skeleton of what a sponsor submits, updates, and files through the module across the lifecycle of an investigation.

**Sponsor identity and contact data.** The legal entity acting as sponsor under Article 72, its address, its contact persons, and. Where the sponsor is established outside the Union. The legal representative designated under Article 62(2).

**The clinical investigation plan.** Annex XV Chapter II specifies the content of the clinical investigation plan: study design, objectives, endpoints, statistical considerations, inclusion and exclusion criteria, procedures, risk-benefit analysis, and monitoring plan. The plan is the core document the module stores.

**The investigator's brochure.** Annex XV requires the investigator's brochure to contain clinical and non-clinical information on the device relevant for the investigation. It is filed and updated through the module.

**Information on the device under investigation.** The technical description, risk class, and safety-relevant data required by Annex XV Chapter II.

**Application and notification records.** The records of submissions made under Articles 70, 74, and 78, together with the decisions of the concerned Member States.

**Ethics and regulatory decisions.** The module records that authorisations have been obtained. Ethics committee opinions themselves are issued under national procedure and reflected in the module record.

**Serious adverse event and device deficiency reports.** Under Article 80, sponsors report serious adverse events and certain device deficiencies to the concerned Member States within defined timelines, through the electronic system.

**Interim and final reports.** Article 77 requires the sponsor to submit a clinical investigation report within defined timeframes after the end, temporary halt, or early termination of the investigation, together with a summary presented in terms easily understandable to the intended user.

**Substantial modifications.** Substantial modifications to the investigation are notified and recorded through the module under Article 75 and the surrounding provisions.

**End-of-investigation notifications.** The notification that the investigation has ended in each Member State, or has been halted or terminated early, flows through the module under Article 77.

Read together, the module content is the administrative and scientific record of the investigation across its whole lifecycle, from first application to final report.

## Sponsor obligations and the module

MDR Article 72 places the responsibility for the initiation, management, and financing of a clinical investigation on the sponsor, together with responsibility for setting up the investigation in accordance with the Regulation. Article 72 and the surrounding provisions create a specific set of obligations that the sponsor discharges partly through the EUDAMED clinical investigation module.

The obligations that touch the module most directly are:

- Filing the initial application under Article 70 (single Member State) or Articles 73 and 78 (multi-Member-State coordinated assessment) via the electronic system.
- Ensuring that the clinical investigation plan, the investigator's brochure, and the device documentation are in the module in the form required by Annex XV.
- Reporting serious adverse events and device deficiencies under Article 80 within the prescribed timelines.
- Notifying substantial modifications under Article 75.
- Filing the end-of-investigation notification and the clinical investigation report under Article 77.
- Keeping the sponsor's own record in the module current.

None of these obligations scale down because the sponsor is a startup. A two-person company running a 20-subject single-site investigation has the same legal sponsor responsibilities under Article 72 as a multinational running a 2,000-subject multi-centre study. The module is the channel through which many of those responsibilities are discharged. A founder planning an investigation should build sponsor operations competence. Or bring it in through an advisor or CRO. Before the first submission, not during it. The companion post [sponsor obligations under MDR Articles 62 and 72](/blog/sponsor-obligations-mdr) covers the sponsor role in full.

## Public transparency implications

Article 33(2) sets transparency as an explicit goal of EUDAMED, and the clinical investigation module is one of the surfaces where that transparency becomes visible. Parts of the data in the module are designed to be publicly accessible.

In particular, the summary of the clinical investigation. Drafted in terms understandable to the intended user and required to accompany the clinical investigation report under Article 77. Is designed to be made public through EUDAMED. The same is true for the existence and broad parameters of an investigation once it has been authorised. The public transparency layer is narrower than the full regulatory record (internal sponsor data, full plans, and event-level clinical information are not publicly posted wholesale), but it is wide enough that a founder should treat anything destined for the module as semi-public from the moment it is drafted.

The practical consequence is that a clinical investigation planned under MDR is not a private scientific exercise. The fact of the investigation, the sponsor's identity, the device, the purpose, and eventually the summary of results become part of the public regulatory record. For a startup this has three implications. First, the lay summary required by Article 77 is a piece of founder-facing writing as much as a regulatory deliverable. It is one of the documents that hospital procurement teams, investors, and competitors will eventually read. Second, a halted or prematurely terminated investigation is also visible, which is a reason to design small, honest studies rather than over-scoped ones that are more likely to fail publicly. Third, regulatory transparency and commercial positioning are no longer separable. They share a surface, and the surface is EUDAMED.

## The Subtract to Ship angle

The EUDAMED clinical investigation module is a place where the Subtract to Ship discipline pays back quickly. The work required by the module is finite and defined by MDR Articles 70, 72, 73, 74, 75, 77, 78, and 80, plus Annex XV. Everything else. Elaborate pre-submission rehearsal binders, custom dashboards, speculative tooling, "EUDAMED readiness" packages sold as a separate engagement. Either traces to one of those provisions or does not belong in the plan.

Strip the work to five things. One clinical investigation plan that conforms to Annex XV. One investigator's brochure. One clean sponsor record. One defined process for Article 80 event reporting that actually runs. One disciplined drafting of the Article 77 report and lay summary. When a founder shows a module work plan that is longer than that list, every extra item has to be defended against a specific article. Usually the extras come out. The framework is covered in full in [the Subtract to Ship framework for MDR](/blog/subtract-to-ship-framework-mdr).

## Reality Check. Where do you stand?

1. Do you know whether your planned investigation will run in a single Member State or several, and whether the Article 73 single-submission route is the one you will use?
2. Have you read MDR Article 34 and confirmed the current functional status of the clinical investigation module before assuming a submission route?
3. Is your sponsor entity under Article 72 clearly identified, with the Article 62(2) legal representative in place if the sponsor is outside the Union?
4. Is your clinical investigation plan drafted against the explicit content requirements of Annex XV Chapter II, not against a generic template?
5. Do you have a defined process to file Article 80 serious adverse event and device deficiency reports within the required timelines, and is a specific person on your team accountable for it?
6. Have you planned the Article 77 final report and lay summary as first-class deliverables, knowing the summary is designed to become public?
7. For each document you intend to file through the module, can you point to the specific article or Annex XV section that requires it?

If you cannot answer four or more of these cleanly, the clinical investigation module is a knowledge gap in your plan, not a checkbox.

## Frequently Asked Questions

**What is the EUDAMED clinical investigation module?**
It is the electronic system on clinical investigations required by MDR Article 73 as part of EUDAMED. It holds sponsor applications, clinical investigation plans, investigator's brochures, notifications, serious adverse event and device deficiency reports under Article 80, and the final clinical investigation report under Article 77 for studies conducted under MDR Articles 62 to 82 and Annex XV.

**What does the Article 73 single submission actually do?**
It lets a sponsor planning a clinical investigation in more than one Member State file a single application through EUDAMED, which is then distributed to every concerned Member State. It replaces the pre-MDR pattern of filing separate national applications for the same study. It does not replace ethics committee approval, which remains a national procedure governed by national law in each Member State.

**Is the EUDAMED clinical investigation module mandatory?**
Mandatory use is tied to MDR Article 34, which conditions the enforceability of EUDAMED-based obligations on the Commission publishing a functional declaration for the system or the specific module, followed by a transitional period. Until that happens for the clinical investigation module, the national application and notification procedures under Articles 70, 74, and 78 continue to apply in parallel. A sponsor should check the current status of the module before assuming a route.

**Who is the sponsor for the purposes of the module?**
The sponsor is the legal entity. Typically the manufacturer or a CRO acting on its behalf. That takes responsibility under MDR Article 72 for the initiation, management, and financing of the clinical investigation. For sponsors established outside the Union, Article 62(2) requires a legal representative within the Union. The sponsor is the account holder in the module and carries the full set of obligations behind every submission.

**What gets published from the module?**
Under MDR Article 33(2) and the provisions on clinical investigation reporting, elements of the clinical investigation record. Including the summary required under Article 77. Are designed to become publicly accessible through EUDAMED. Internal sponsor data and full event-level clinical data are not published wholesale. The public layer is narrower than the full record but wide enough that a founder should treat module content as semi-public from the moment it is drafted.

**Does the module replace ethics committee review?**
No. Ethics committee review is governed by national law in each Member State where the investigation runs and is obtained through national ethics procedures. The EUDAMED clinical investigation module records that the required authorisations are in place and holds the regulatory workflow around them, but it does not issue or replace an ethics committee opinion.

## Related reading

- [What is EUDAMED? The European Database on Medical Devices explained for startups](/blog/what-is-eudamed-european-database-medical-devices) – the cluster pillar covering all six modules.
- [The EUDAMED certificates module](/blog/eudamed-certificates-module) – how Notified Body certificates appear in EUDAMED.
- [What is a clinical investigation under MDR?](/blog/what-is-clinical-investigation-mdr) – the cluster pillar on clinical investigations and when they are required.
- [MDR Article 62 general requirements for clinical investigations](/blog/mdr-article-62-general-requirements) – the baseline article on clinical investigation design and conduct.
- [Sponsor obligations under MDR Articles 62 and 72](/blog/sponsor-obligations-mdr) – what the sponsor role actually requires of a startup.
- [Annex XV content of the clinical investigation plan](/blog/annex-xv-clinical-investigation-plan) – the specification the module expects every plan to meet.
- [MDR Article 80 serious adverse event reporting](/blog/mdr-article-80-serious-adverse-event-reporting) – the reporting obligation that runs through the module during an active investigation.
- [The Subtract to Ship framework for MDR](/blog/subtract-to-ship-framework-mdr) – the methodology for cutting module work down to what the Regulation actually requires.

## Sources

1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, Article 33 (European database on medical devices), Article 34 (functioning of Eudamed), Article 62 (general requirements regarding clinical investigations conducted to demonstrate conformity of devices), Article 70 (application for clinical investigations), Article 71 (assessment by Member States), Article 72 (conduct of a clinical investigation), Article 73 (electronic system on clinical investigations), Article 74 (clinical investigations regarding devices bearing the CE marking), Article 75 (substantial modifications to clinical investigations), Article 77 (information from the sponsor at the end of a clinical investigation or in the event of a temporary halt or early termination), Article 78 (coordinated assessment procedure for clinical investigations), Article 80 (recording and reporting of adverse events that occur during clinical investigations), Annex XV (clinical investigations). Official Journal L 117, 5.5.2017.
2. Commission Implementing Regulation (EU) 2021/2078 of 26 November 2021 laying down rules for the application of Regulation (EU) 2017/745 as regards the European Database on Medical Devices (Eudamed). OJ L 426, 29.11.2021.
3. EN ISO 14155:2020+A11:2024. Clinical investigation of medical devices for human subjects. Good clinical practice.
4. European Commission, EUDAMED information page. Current module status, user guides, and Commission notices on functional declarations. (Readers should consult the Commission page directly for the live mandatory/voluntary status of the clinical investigation module before acting.)

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*This post sits in the EUDAMED, UDI and Registration cluster of the Subtract to Ship: MDR blog. Authored by Felix Lenhard and Tibor Zechmeister. If the functional status of the clinical investigation module has shifted since the last updated date on this post, the living companion on EUDAMED status supersedes any time-sensitive statements here, and MDR Articles 33, 34, 73, and the rest of Chapter VI remain the binding legal reference.*

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*This post is part of the [EUDAMED, UDI & Registration](https://zechmeister-solutions.com/en/blog/category/eudamed-udi) cluster in the [Subtract to Ship: MDR Blog](https://zechmeister-solutions.com/en/blog). For EU MDR certification consulting, see [zechmeister-solutions.com](https://zechmeister-solutions.com).*