---
title: How to Apply for Clinical Investigation Approval with Your National Competent Authority
description: MDR clinical investigation approval application: Annex XV dossier contents, Article 70 timelines, and multi-state coordination for startup sponsors.
authors: Tibor Zechmeister, Felix Lenhard
category: Clinical Evaluation & Investigations
primary_keyword: MDR clinical investigation approval application
canonical_url: https://zechmeister-solutions.com/en/blog/clinical-investigation-approval-application
source: zechmeister-solutions.com
license: All rights reserved. Content may be cited with attribution and a link to the canonical URL.
---

# How to Apply for Clinical Investigation Approval with Your National Competent Authority

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

> **To apply for clinical investigation approval under MDR, the sponsor submits an application dossier to the competent authority of each member state where the investigation will run, using the national electronic system specified by that member state. The dossier content is prescribed by Annex XV Chapter II of Regulation (EU) 2017/745 and includes the application form, the investigator's brochure, the clinical investigation plan, the informed consent documents, proof of insurance, and the full regulatory dossier for the device. Under MDR Article 70, the competent authority validates the application within 10 days for most devices and has up to 45 days from validation to notify the sponsor of its decision, extendable by 20 days for expert consultation. Multi-state investigations require a coordinated submission to every member state concerned, with ethics committee approval handled in parallel under national procedures.**

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

---

## TL;DR

- The sponsor applies to the competent authority of every member state where the clinical investigation will be conducted. There is no single EU-wide submission for non-coordinated investigations.
- The dossier content is defined by Annex XV Chapter II of Regulation (EU) 2017/745. Miss a section, and the application does not even reach validation.
- Under Article 70, the competent authority has up to 10 days to validate the application and up to 45 further days to take a decision, extendable by 20 days if expert consultation is needed.
- For Class III devices and certain implantable or Class IIb active devices, Article 71 requires the authority to examine scientific and clinical aspects more deeply, and the timelines can run to the longer end of the legal window.
- Ethics committee opinion runs in parallel under national law and is a separate gate. The sponsor manages both tracks at once.
- Multi-state investigations are coordinated under Article 78 where the sponsor opts in, but the default is member-state-by-member-state submission.

---

## Why the application is the moment the investigation becomes real

For months before the application, a clinical investigation is a set of documents on a sponsor's laptop. The clinical investigation plan is in draft eight. The investigator's brochure has been through three reviewers. The insurance broker has a quote but the policy has not bound. The sites have been scouted but no contracts are signed. None of that is visible to a regulator.

The application changes all of it. The moment the dossier arrives in the national electronic system of a competent authority, the investigation is a real regulatory event with a clock on it. Every weakness in the dossier is now visible to people whose job is to find weaknesses. Every gap between what the plan promises and what the sponsor can actually execute is now in the record.

This is the point at which most startup sponsors discover whether the preceding six months of work were tight enough. The dossier is not the place to learn Annex XV. The dossier is the place to prove you already learned it.

## The MDR text. What Articles 70 to 78 and Annex XV actually say

The legal foundation for the application process lives in Chapter VI of Regulation (EU) 2017/745. The articles that matter most for the application itself are 70 through 78, with Annex XV providing the dossier content.

**Article 70. Application for clinical investigations.** Sets out the procedure. The sponsor submits the application to the member state or states in which the investigation is to be conducted, together with the documentation referred to in Chapter II of Annex XV. The competent authority checks, within a defined window, that the investigation falls within the scope of the Regulation and that the application is complete. The authority then has a further window to take a decision on whether to authorise the investigation.

**Article 71. Assessment by member states.** For certain higher-risk device categories, the competent authority conducts a deeper scientific and clinical review. This article specifies the additional grounds on which an authority may refuse authorisation.

**Article 72. Conduct of a clinical investigation.** Once authorised, the sponsor conducts the investigation in accordance with the clinical investigation plan, the Regulation, and the applicable standards. This is the article that governs what happens after approval lands.

**Article 73. Electronic system on clinical investigations.** Establishes the EU electronic system that will eventually host clinical investigation information. Until that system is fully functional, national electronic systems or paper-based national procedures apply.

**Article 74. Clinical investigations regarding devices bearing the CE marking.** Governs post-market clinical follow-up investigations on already-certified devices where the investigation is not intended to modify the intended purpose.

**Article 75. Substantial modifications to clinical investigations.** Changes to the authorised investigation must be notified and, where they are substantial, authorised before they take effect.

**Article 76. Corrective measures to be taken by member states.** The authority's powers when an investigation is not being conducted in compliance.

**Article 77. Information from the sponsor at the end of a clinical investigation or in the event of a temporary halt or early termination.** Reporting obligations at the end of the study.

**Article 78. Coordinated assessment procedure for clinical investigations.** The voluntary coordinated procedure for multi-state investigations, under which one member state acts as coordinating member state for the scientific assessment.

**Annex XV Chapter II. Documentation regarding the application for clinical investigation.** Lists the content of the application dossier. This is the checklist the sponsor must satisfy before the dossier is even accepted for validation.

Every sponsor preparing an application reads these articles and Annex XV Chapter II personally. Not in a summary, not in a consultant's presentation. The articles are short. The time cost is an afternoon. The consequence of skipping it shows up as an avoidable non-validation six weeks later.

## The application dossier. Annex XV Chapter II contents

Annex XV Chapter II specifies what the application dossier contains. Read as a working sponsor checklist, the content covers:

- **The application form** in the format required by the national electronic system of the member state concerned.
- **The investigator's brochure**, containing the clinical and non-clinical information on the investigational device that is relevant for the investigation and available at the time of application.
- **The clinical investigation plan (CIP)**, containing the rationale, objectives, design, methodology, monitoring, statistical considerations, organisation, and conduct of the investigation.
- **Information related to the sponsor**. Identification, legal form, contact person for the application, and declaration that the sponsor takes responsibility for the investigation.
- **Information related to the principal investigator, the coordinating investigator where applicable, and the investigation sites**. Qualifications, role, and site suitability.
- **Documentation on the device under investigation**. Description of the device, its intended purpose, the manufacturing process summary, the results of risk analysis, and the pre-clinical evidence package supporting the safety of starting the investigation.
- **The informed consent form and the subject information sheet**, in the language or languages of the subjects, with the content required by Article 63.
- **Proof of insurance or indemnification arrangements** for damages to subjects arising from their participation, as required by Article 62(4).
- **The documents used to obtain informed consent**, including any supplementary information materials.
- **The procedures for recording and reporting adverse events and device deficiencies** under Article 80.
- **A statement that the clinical investigation will be conducted in accordance with the Regulation** and with the applicable version of EN ISO 14155:2020+A11:2024.
- **Additional documentation required by the specific member state** under national procedures.

That last item is the one startup sponsors most often underestimate. Annex XV Chapter II is the EU floor, not the national ceiling. Every member state has its own electronic system, its own language requirements, and in most cases its own additional documentation. Fee schedules, national declarations, data protection impact assessments, specific investigator declarations, or national-form versions of the consent materials.

Before the dossier is assembled, the sponsor downloads the exact national checklist from the competent authority website of every member state concerned and maps Annex XV Chapter II content to the national form fields. Any mismatch is resolved by producing the national-specific content, not by submitting a generic EU dossier and hoping.

## Article 70. Validation and decision timelines

Article 70 structures the timelines on the authority side into two distinct phases.

**Phase one. Validation.** On receipt of the application, the competent authority checks within a defined window whether the application is within scope, whether the device is a medical device covered by the Regulation, and whether the dossier contains the documentation required by Annex XV Chapter II. For most device categories, this validation window is up to 10 days. During validation, the authority can raise questions and request missing items. Until the dossier is validated, the clock on the substantive decision has not even started.

**Phase two. Decision.** Once the application is validated, the competent authority has up to a further window. Commonly up to 45 days from validation. To notify the sponsor of its decision. During this window the authority conducts the substantive assessment: the scientific soundness of the design, the risk-benefit justification, the adequacy of the informed consent, the qualifications of the investigators, the insurance arrangements, and the protection of subjects. Where the authority requires expert consultation for higher-risk device categories, the decision window can be extended by a further period. Commonly up to 20 days. Which the authority notifies to the sponsor in writing.

For implantable devices, Class III devices, and certain Class IIb active devices, Article 71 adds substantive assessment criteria that push the authority toward the longer end of the legal window. Sponsors of these devices plan the application timeline around the upper bound, not the lower bound.

Two practical consequences follow from these timelines. First, any question the authority raises during validation pauses the clock and pushes the decision date out. A dossier that takes three rounds of clarification to validate loses weeks. Second, the clock runs on calendar days as defined by the national procedure. Not on the sponsor's working days. Holiday periods in the relevant member state affect planning, especially in July and August and around year end.

Where this post references day counts, sponsors confirm the exact current numbers for the member state of interest against the consolidated text of Article 70 and the relevant national procedure before committing to a project timeline. The mechanism. A short validation window, a substantive decision window measured in weeks, and a defined extension for expert consultation. Is the structure every application planning exercise is built around.

## Multi-state investigations and the coordinated procedure

The default assumption in MDR Chapter VI is that a clinical investigation runs in one member state and the sponsor applies to that state's competent authority. The reality for most startups running a pivotal investigation is that they want to run in two, three, or more member states to hit recruitment targets, diversify sites, and build evidence across health systems.

For multi-state investigations, two pathways exist.

**The default. Parallel national submissions.** The sponsor submits an application to the competent authority of every member state where the investigation will run, using each member state's national electronic system, with the national-specific adaptations of the dossier. Each authority runs its own assessment on its own clock. The sponsor manages multiple review tracks in parallel. This is operationally heavy but legally straightforward, and it is the pathway most sponsors use today where the coordinated procedure is not yet available or not yet chosen.

**The coordinated procedure under Article 78.** Where the sponsor opts in and the procedure is available, one member state acts as the coordinating member state for the scientific assessment. The scientific part of the assessment is conducted once for all participating member states, while each member state retains its own decision on aspects such as informed consent content, liability, and compensation arrangements under its national law. The coordinated procedure reduces duplication on the scientific side but adds its own procedural steps.

Whichever pathway is used, the ethics committee opinion runs on a separate, parallel track under the national law of each participating member state. Ethics approval is not subsumed into the competent authority review. It is a second, independent gate. A sponsor planning for a multi-state investigation plans both tracks from day one.

## The parallel track. Ethics committee opinion

Article 62(4) requires that every clinical investigation under MDR has a positive opinion from the ethics committee of the member state or states where it will be conducted. The ethics committee pathway, the composition of the committee, and the procedural timelines are defined by the national law of each member state. The MDR defers to national procedure here.

This has two consequences for application planning. First, the sponsor begins the ethics committee submission process in parallel with, not after, the competent authority application. In several member states the two submissions are administratively linked through a single national portal; in others they are separate. Either way, the sponsor tracks them as two deliverables. Second, the ethics committee can require changes to the consent documents, the subject information sheet, or the protocol that have to be reflected in the competent authority dossier. A well-run application keeps both versions in lockstep and avoids the scenario where the ethics committee approves one version of the consent form and the competent authority reviews a different one.

## Test. A realistic timeline scenario

A two-site single-member-state investigation for a Class IIb active device. Sponsor is a startup running its pivotal study in Germany.

- **Week 0.** Clinical investigation plan locked at version 1.0. Investigator's brochure finalised. Insurance bound. Both site contracts signed. All Annex XV Chapter II content assembled and mapped to the BfArM national checklist. Ethics committee submission prepared in parallel.
- **Week 1.** Sponsor submits to BfArM through the national electronic system and to the responsible ethics committee through the national pathway. Both clocks start.
- **Weeks 2-3.** Validation window. BfArM raises two minor validation questions. A missing version number on the investigator's brochure, and a clarification on the principal investigator's qualification documentation. Sponsor responds within 48 hours both times. Validation completes at the end of week three.
- **Weeks 4-9.** Substantive assessment window. Ethics committee issues questions on the consent form wording and on the data protection arrangements. Sponsor updates the consent form, feeds the updated version to BfArM so both tracks stay synchronised, and responds to ethics. Ethics approval lands in week 7. BfArM decision lands in week 9.
- **Week 10.** Both approvals in hand. Site initiation visits scheduled. First subject enrolment planned for week 12.

The numbers in this scenario are realistic for a well-prepared Class IIb application in a single German-speaking member state. A multi-state application, a Class III device, or a dossier that required more validation rounds would run meaningfully longer. A dossier that does not survive validation on the first attempt is back at the sponsor's desk with weeks lost.

## Ship. The application checklist

Before submission, the sponsor confirms every item:

- [ ] Sponsor legal entity identified and authorised signatory confirmed
- [ ] National electronic system account active in every member state concerned
- [ ] Annex XV Chapter II content complete and mapped to the national checklist of every member state
- [ ] Clinical investigation plan locked at a named version, dated, signed
- [ ] Investigator's brochure locked at a named version, dated, signed
- [ ] Principal investigator CVs, GCP training certificates, and qualification assessments in the dossier for every site
- [ ] Site suitability documentation for every site
- [ ] Pre-clinical evidence package complete and referenced from the CIP
- [ ] Risk management file current and referenced
- [ ] Informed consent form and subject information sheet in the correct language or languages for every site
- [ ] Insurance or indemnification arrangement bound, certificate in the dossier, coverage verified against the national requirements of every member state concerned
- [ ] Article 80 adverse event reporting procedure documented in the CIP and in the sponsor's QMS
- [ ] Ethics committee submission prepared and queued for parallel submission
- [ ] Fees paid or queued per the national procedure of every member state concerned
- [ ] Internal project plan reflecting the validation and decision windows, with buffer for clarification rounds

A dossier that is missing any one of these items is not ready to submit. The sponsor who submits before the checklist is clean spends the next three weeks answering validation questions instead of running the study.

## Reality Check. Where do you stand?

1. Have you personally read Article 70 and Annex XV Chapter II, or only a consultant summary?
2. Is every Annex XV Chapter II section in your dossier and mapped to the national checklist of every member state where you will submit?
3. Is your clinical investigation plan locked at a named version, with change control in place so mid-review updates do not desynchronise the dossier?
4. Is your insurance policy bound, with the certificate in the dossier, and does the coverage meet the national requirements of every member state concerned?
5. Do you have ethics committee submissions prepared for parallel filing with the competent authority application?
6. Have you confirmed the current validation and decision windows applicable to your device class and member state against the consolidated MDR text?
7. Do you have a named person who monitors the national electronic system daily during the validation window and can turn around clarification responses within 48 hours?
8. For multi-state investigations, have you decided between parallel national submissions and the Article 78 coordinated procedure, and does your project plan reflect that decision?
9. Is your pre-clinical evidence package strong enough that a substantive assessor will conclude the risk-benefit balance is justified on the first read?
10. If the competent authority asks a question that requires a change to the CIP, do you have a process for updating the plan, the ethics submission, and every site contract in lockstep?

## Frequently Asked Questions

**How long does MDR clinical investigation approval take?**
Under MDR Article 70, the competent authority validates the application within a defined window (commonly up to 10 days for most device categories) and then has a further window (commonly up to 45 days from validation) to take a decision, extendable where expert consultation is needed. For Class III and certain implantable or Class IIb active devices covered by Article 71, sponsors plan toward the upper bound. Sponsors confirm the exact current day counts against the consolidated text of Regulation (EU) 2017/745 before planning the project timeline.

**Where do I submit the application?**
To the competent authority of every member state where the investigation will be conducted, using the national electronic system specified by that member state. There is no EU-wide single submission system for non-coordinated clinical investigations. For investigations that opt into the coordinated procedure under Article 78, one member state acts as the coordinating member state for the scientific assessment, but each participating member state still takes its own decision.

**What documentation does MDR Annex XV Chapter II require?**
Annex XV Chapter II specifies the content of the application dossier: the application form, the investigator's brochure, the clinical investigation plan, sponsor and investigator information, a full description of the device under investigation with the pre-clinical evidence package, the informed consent documents, proof of insurance or indemnification, the adverse event reporting procedures, and a statement of compliance with the Regulation. Member states add national-specific documentation on top of this EU floor.

**Does ethics committee approval come from the competent authority?**
No. Ethics committee opinion runs on a separate track under the national law of each member state. The sponsor submits to the ethics committee in parallel with the competent authority application. Both approvals are required before the first subject can be enrolled. In some member states the two submissions are administratively linked through a single national portal, but the decisions are issued by separate bodies.

**Can I submit to multiple member states at once?**
Yes. For multi-state investigations, the default pathway is parallel national submissions to every member state concerned, with each authority running its own assessment. Alternatively, where available and where the sponsor opts in, the Article 78 coordinated assessment procedure consolidates the scientific part of the assessment under a coordinating member state, while each member state retains its own decision on national aspects such as informed consent and liability arrangements.

**What happens if the competent authority asks questions during validation?**
The clock on the substantive decision does not start until the application is validated. Every clarification round during validation extends the overall timeline. Sponsors plan for one clarification round as realistic, and target a dossier clean enough that validation completes on the first review. A dossier that needs three rounds of clarification has a problem that no speed of response on the sponsor side can fully compensate for.

**Do I need approval before starting the investigation?**
Yes. Under MDR, a clinical investigation conducted to demonstrate conformity cannot begin enrolment in a member state until the competent authority has authorised it (or the authorisation is deemed to have been granted under the applicable procedure) and the ethics committee has issued a positive opinion. Site initiation, subject screening, and enrolment all wait on both approvals.

## Related reading

- [The Sponsor's Obligations in Clinical Investigations Under MDR Article 62(4)](/blog/sponsor-obligations-clinical-investigations-mdr) – the legal obligations the sponsor carries into the application.
- [MDR Chapter VI Clinical Investigations. The Full Framework](/blog/mdr-chapter-vi-clinical-investigations) – the article-by-article map of Articles 62 to 82.
- [Ethics Committee Approval for Clinical Investigations Under MDR](/blog/ethics-committee-clinical-investigations-mdr) – the parallel track the sponsor runs alongside the competent authority application.
- [Writing a Clinical Investigation Plan (CIP) Under MDR Article 62](/blog/write-clinical-investigation-plan-cip) – the core document in the Annex XV Chapter II dossier.
- [Investigator's Brochure Under MDR Annex XV](/blog/investigators-brochure-mdr-annex-xv) – the companion document in the dossier.

## Sources

1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical 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 76 (corrective measures to be taken by member states), 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), Annex XV (clinical investigations), Chapter II (documentation regarding the application for clinical investigation). Official Journal L 117, 5.5.2017.
2. EN ISO 14155:2020+A11:2024. Clinical investigation of medical devices for human subjects. Good clinical practice.

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*This post sits in the Clinical Evaluation & Clinical Investigations cluster of the Subtract to Ship: MDR blog. Authored by Felix Lenhard and Tibor Zechmeister. If you are preparing an Annex XV Chapter II dossier for submission to a national competent authority and want a pre-submission review against Article 70 and the national checklist before the clock starts, Zechmeister Strategic Solutions works with founders on exactly that review.*

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*This post is part of the [Clinical Evaluation & Investigations](https://zechmeister-solutions.com/en/blog/category/clinical-evaluation) 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).*