---
title: Informed Consent Under MDR Article 63: Requirements for Clinical Investigation Subjects
description: MDR Article 63 sets the informed consent rules for clinical investigations. Here is what the consent form must contain and how to draft it.
authors: Tibor Zechmeister, Felix Lenhard
category: Clinical Evaluation & Investigations
primary_keyword: MDR Article 63 informed consent clinical investigation
canonical_url: https://zechmeister-solutions.com/en/blog/informed-consent-mdr-article-63
source: zechmeister-solutions.com
license: All rights reserved. Content may be cited with attribution and a link to the canonical URL.
---

# Informed Consent Under MDR Article 63: Requirements for Clinical Investigation Subjects

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

> **MDR Article 63 requires that informed consent in a clinical investigation be given freely and in writing by the subject (or the subject's legally designated representative) after the subject has been informed, in a prior interview with a member of the investigating team, about the nature, objectives, benefits, implications, risks, and inconveniences of the investigation, the conditions under which it will be conducted, alternative treatments, subject rights, and the right to withdraw at any time without detriment. The information must be comprehensive, concise, clear, relevant, and understandable to the subject, documented on a signed and dated consent form, and made available in a language the subject actually understands. MDR Articles 64 to 68 add specific protections for incapacitated subjects, minors, pregnant and breastfeeding women, and subjects in emergency situations. The operational procedures are governed by EN ISO 14155:2020+A11:2024, the harmonised Good Clinical Practice standard.**

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

---

## TL;DR

- Informed consent under MDR Article 63 is freely given, informed, written consent, documented on a signed and dated form, after a prior interview with a member of the investigating team.
- The information given to the subject must be comprehensive, concise, clear, relevant, and understandable, and must be in a language the subject actually understands.
- Article 63 specifies the content the subject must be informed about — nature, objectives, benefits, implications, foreseeable risks, inconveniences, conditions, alternative treatments, and the right to withdraw at any time without detriment.
- MDR Articles 64 to 68 add protections for incapacitated adults, minors, pregnant and breastfeeding women, and subjects in emergency situations.
- EN ISO 14155:2020+A11:2024 operationalises the consent procedure and is the standard ethics committees and Notified Bodies expect to see applied.
- The consent form is typically the single most scrutinised document in the ethics committee submission. A copy-pasted template is the single most common reason a dossier bounces.

---

## The consent form that sank a submission

A founder running a small neurostimulation startup handed the consent form to his clinical research associate on a Friday afternoon and asked her to have it ready for the ethics committee submission on Monday. She copied the form from a prior study on the same indication, swapped in the new device name, adjusted two paragraphs, and sent it to the lawyer for sign-off. The lawyer checked the GDPR clauses and approved it. The submission went out.

The committee came back three weeks later with fourteen comments on the consent form alone. The risks section mentioned adverse events that did not apply to the new device and omitted two that did. The benefits section used language the committee flagged as promotional — the word "innovative" appeared four times. The withdrawal clause said subjects could withdraw "with reasonable notice," which is not what Article 63 says. The subject information was written at a reading level the committee's lay members considered inaccessible to the target population. The right-to-complain contact point pointed to the sponsor's legal mailbox rather than to an independent party. The patient information was only in German, but the planned site enrolled Turkish-speaking patients as well.

The founder rewrote the form with the principal investigator and the sponsor medical lead over two weeks. The second submission passed. The three weeks of bounce and two weeks of rewrite cost the project five weeks the runway had not budgeted for. None of the committee's findings were unreasonable. Every one of them was the predictable result of treating the consent form as a template to be swapped rather than a document to be drafted.

Informed consent is where a clinical investigation proves it respects the people it enrols. Article 63 sets the minimum content and procedure. This post walks the article, the vulnerable-subject provisions in Articles 64 to 68, the good-versus-bad pattern, and the drafting playbook that holds up in review. It is the companion to [Ethical Approval for Clinical Investigations: Ethics Committee Requirements Under MDR](/blog/ethics-committee-clinical-investigations-mdr), to [MDR Chapter VI: Clinical Investigations — The Full Regulatory Framework](/blog/mdr-chapter-vi-clinical-investigations), and to [What Is a Clinical Investigation Under MDR? When Your Startup Needs to Run a Study](/blog/what-is-clinical-investigation-mdr).

## What MDR Article 63 actually requires

MDR Article 63 is the provision that governs informed consent in clinical investigations. It is structured around two ideas: the conditions under which consent is valid, and the content the subject must be informed about before giving it.

**Consent must be freely given, informed, and in writing.** The subject, or where the subject is unable to give informed consent the subject's legally designated representative, dates and signs the consent form after having been properly informed. In cases where the subject is unable to write, consent may be given and recorded through appropriate alternative means in the presence of at least one impartial witness, with the conditions and documentation set by the national procedure.

**Consent follows a prior interview.** The information is given to the subject in a prior interview with a member of the investigating team who is appropriately qualified under national law. The subject is given adequate time to consider the decision to participate. Questions are answered. Nothing about the consent process may be rushed or coerced.

**The information must be comprehensible.** Article 63 requires that the information given to the subject be comprehensive, concise, clear, relevant, and understandable to the subject. In practice this means plain language, in the language the subject actually understands, with technical terms explained. It means the reading level is matched to the target population, not to the regulatory team drafting the document.

**The content list.** The subject must be informed about the nature, objectives, benefits, implications, foreseeable risks, and inconveniences of the clinical investigation; the conditions under which it will be conducted; the alternative treatments available, including follow-up measures if the subject's participation is discontinued; the subject's rights and guarantees regarding his or her protection, in particular the right to refuse to participate and the right to withdraw from the clinical investigation at any time without any resulting detriment and without having to provide any justification; the conditions under which the investigation is to be conducted including the expected duration of the subject's participation; and the possible alternatives and the contact point where further information can be obtained. The content of the data protection notice under the GDPR is handled alongside but is not itself set by Article 63.

**The right to withdraw.** The right to withdraw at any time without detriment and without having to justify the decision is an absolute provision of Article 63. A consent form that conditions withdrawal on notice periods, on completion of procedures, or on any form of detriment is not compliant.

## Vulnerable subjects — MDR Articles 64 to 68

Article 63 sets the baseline. Articles 64 to 68 layer additional protections on top of it for subjects who cannot give fully autonomous consent or whose situation requires enhanced safeguards.

**Article 64 — incapacitated subjects.** A clinical investigation on an incapacitated subject who has not given, or has not refused to give, informed consent before the onset of the incapacity may be conducted only where the specific conditions of Article 64 are met, including that informed consent has been obtained from the legally designated representative, that the subject has received information adapted to his or her capacity to understand, and that an explicit wish of the subject capable of forming an opinion and assessing the information is respected.

**Article 65 — minors.** A clinical investigation on a minor may be conducted only where the specific conditions of Article 65 are met, including that the informed consent of the legally designated representative has been obtained, that the minor has received information from the investigators in a way adapted to his or her age and mental maturity, and that any explicit wish of a minor capable of forming an opinion and assessing that information to refuse participation or to withdraw is respected.

**Article 66 — pregnant or breastfeeding women.** A clinical investigation on a pregnant or breastfeeding woman may be conducted only where the specific conditions of Article 66 are met, including that the investigation has the potential to produce a direct benefit for the woman or the embryo, foetus, or child after birth outweighing the risks and burdens involved, or where the research cannot be carried out on women who are not pregnant or breastfeeding and poses only minimal risk and minimal burden.

**Article 67 — additional national measures.** Member states may maintain or introduce additional measures regarding persons performing mandatory military service, persons deprived of liberty, persons who, due to a judicial decision, cannot take part in clinical investigations, or persons in residential care institutions.

**Article 68 — emergency situations.** By way of derogation, where due to the urgency of the situation it is impossible to obtain prior informed consent from the subject or from the legally designated representative, the investigation may be initiated only where the specific conditions of Article 68 are met, including that the subject is informed as soon as possible and that consent to continue participation is requested as soon as practicable.

Each of these articles has its own conditions, and a sponsor drafting a consent process that touches any of these populations must read the relevant article in full and reflect its conditions in the consent materials and in the CIP. A generic adult consent form does not cover minors, does not cover incapacitated adults, and does not cover emergency situations.

## EN ISO 14155:2020+A11:2024 — how the consent procedure actually runs

EN ISO 14155:2020+A11:2024 — Clinical investigation of medical devices for human subjects — Good clinical practice — is the harmonised standard that operationalises compliance with MDR Chapter VI, including the informed consent procedure. Where Article 63 sets the what, ISO 14155 sets the how: who conducts the interview, how the subject is given time to consider, how the consent form is signed and dated, how the signed copy is filed, how re-consent is handled when new information becomes available during the study, and how the process is documented in the site file. Ethics committees and Notified Bodies expect the consent procedure to follow ISO 14155. A sponsor who operationalises consent outside the standard is creating audit findings before the first subject is enrolled.

## Good versus bad — what a compliant consent form looks like

A compliant consent form is short enough to read, specific to the investigation, and written in the language of the subject. A non-compliant consent form is any one of these things: generic, promotional, unreadable to the target population, silent on withdrawal, or in the wrong language.

**A compliant benefits section** states the direct benefits to the subject if any are expected and clearly says so if none are expected. "This study does not offer a direct benefit to you. The purpose is to evaluate whether the device works and is safe, which may benefit future patients with this condition." That is a compliant sentence. "This innovative investigation offers you access to a cutting-edge treatment" is not.

**A compliant risks section** lists the foreseeable risks of the device and the procedures, in plain language, matched to the risk management file under EN ISO 14971:2019+A11:2021 and to the investigator's brochure. It does not mention risks from a different device. It does not omit known risks because they are uncomfortable to read. It does not bury the risks at the end of a ten-page document.

**A compliant withdrawal clause** says the subject may withdraw at any time, without giving a reason, without any detriment to their care, and without affecting their relationship with the investigator. It does not require notice. It does not condition withdrawal on the completion of procedures. It does not make withdrawal feel like a breach.

**A compliant contact block** gives the subject two contact points: the principal investigator for study-related questions, and an independent point for complaints or concerns — typically the ethics committee or a patient representative — not the sponsor's legal mailbox.

**A compliant language section** means the form is available in every language the enrolment population speaks. If the site enrols Turkish-speaking patients as well as German-speaking patients, there are two validated versions. Translations are back-translated and documented.

## The informed consent drafting playbook

The sequence that produces a consent form that passes the ethics committee on the first cycle.

**Step 1 — Start from the risk management file, not from a template.** The risks the subject needs to be informed about are the risks in the risk management file under EN ISO 14971:2019+A11:2021, translated into plain language, not the risks from a template form for a different device. Open the risk file and the investigator's brochure. Work from there.

**Step 2 — Draft with the principal investigator and the sponsor medical lead.** The people who understand the device and the investigation are the people who draft the form. A CRA, a lawyer, or a template service can format and review, but cannot originate the content.

**Step 3 — Write at the target reading level.** The form is written for the subject, not for the regulatory team. Match the reading level to the target population. Short sentences. Plain words. Technical terms explained on first use. A good heuristic: if a teenager with no medical background cannot follow it, it is not ready.

**Step 4 — Cover the Article 63 content list explicitly.** Nature, objectives, benefits, implications, foreseeable risks, inconveniences, conditions, duration, alternatives, right to refuse, right to withdraw without detriment, contact points. Run the list as a checklist. A section that is missing is a committee finding waiting to happen.

**Step 5 — Handle vulnerable-subject provisions if applicable.** If the investigation enrols minors, incapacitated adults, pregnant or breastfeeding women, or subjects in emergency situations, reflect the specific conditions of Articles 64 to 68 in the consent materials — including assent forms for minors, representative consent for incapacitated adults, and delayed-consent procedures for emergency situations.

**Step 6 — Translate and back-translate.** Every language the enrolment population speaks has its own validated version. Back-translation is documented in the site file.

**Step 7 — Pressure-test against EN ISO 14155 and a lay reader.** One pass against the ISO 14155 consent requirements. One pass by a lay reader — someone not on the investigating team and not in the sponsor's regulatory group — to catch language that the drafters can no longer see as unclear.

**Step 8 — Submit the consent form with the CIP, the investigator's brochure, and the other Annex XV content to the ethics committee.** The consent form does not travel alone. It travels inside the dossier specified by Annex XV and reviewed by the committee as a whole.

## Common mistakes startups make

**Copying a template.** The single most common error. Consent forms from prior studies, from template banks, or from other sponsors almost never match the specific risks, benefits, procedures, and population of the current investigation. Committees read carefully and catch it immediately.

**Writing at a regulatory reading level.** A consent form drafted by lawyers reads like a contract. Subjects do not read contracts. The form has to be comprehensible to the actual population enrolling, not to the team writing it.

**Understating risks or overstating benefits.** Committees read consent forms looking for exactly this. Marketing-sounding language in a consent form is a red flag. "Innovative," "cutting-edge," "breakthrough" — all banned from consent vocabulary.

**Conditioning withdrawal.** Any language that makes withdrawal feel like a breach, that requires notice, or that ties withdrawal to detriment is non-compliant with Article 63.

**Ignoring vulnerable-subject provisions.** Enrolling minors or incapacitated adults without reading Articles 64 and 65 and reflecting their conditions in the consent materials is a finding waiting to happen.

**Skipping the language coverage.** Running a site with a multilingual population and providing the consent form in only one language is both an Article 63 issue and an ethics committee finding.

## Reality Check — Where do you stand?

1. Is your consent form drafted specifically for this investigation, starting from the risk management file and the investigator's brochure, rather than copied from a template?
2. Is the form written at a reading level your actual target population can follow, verified by a lay reader outside the sponsor team?
3. Does the form cover every item on the Article 63 content list — nature, objectives, benefits, implications, risks, inconveniences, conditions, duration, alternatives, rights, withdrawal, contact points?
4. Is the right to withdraw stated as "at any time, without reason, without detriment," with no conditions and no notice requirements?
5. If the investigation enrols minors, incapacitated adults, pregnant or breastfeeding women, or emergency subjects, have you reflected the specific conditions of Articles 64 to 68 in the consent materials?
6. Is the form available in every language the enrolment population speaks, with back-translation documented in the site file?
7. Does your consent procedure follow EN ISO 14155:2020+A11:2024, with the prior interview, adequate time for consideration, signed and dated form, and re-consent procedure all documented in SOPs?

## Frequently Asked Questions

**What does MDR Article 63 require for informed consent in a clinical investigation?**
MDR Article 63 requires that informed consent be freely given, informed, and in writing, with the subject (or the legally designated representative where the subject cannot give consent) signing and dating the consent form after a prior interview with a member of the investigating team. The subject must be informed about the nature, objectives, benefits, implications, foreseeable risks, inconveniences, conditions, duration, alternative treatments, and rights, including the right to withdraw at any time without detriment and without justification.

**What has to be in the subject information sheet under MDR Article 63?**
The content list in Article 63 covers the nature, objectives, benefits, implications, foreseeable risks, and inconveniences of the investigation; the conditions under which it is conducted including expected duration; alternative treatments and follow-up if the subject discontinues; the subject's rights and guarantees, including the right to refuse and withdraw without detriment; and the contact point for further information. The information must be comprehensive, concise, clear, relevant, and understandable to the subject.

**In what language does the informed consent form have to be?**
MDR Article 63 requires that the information given to the subject be understandable to the subject. In practice this means the consent form must be in a language the subject actually speaks and reads. A site with a multilingual enrolment population requires validated translations for every language represented, with back-translation documented in the site file.

**What protections apply to vulnerable subjects under MDR?**
MDR Articles 64 to 68 add protections beyond Article 63 for specific populations: Article 64 for incapacitated subjects, Article 65 for minors, Article 66 for pregnant or breastfeeding women, Article 67 for additional national measures regarding persons in special circumstances, and Article 68 for subjects in emergency situations. Each article has its own conditions that the consent materials and procedure must reflect.

**Can a subject withdraw from a clinical investigation once consent has been given?**
Yes. MDR Article 63 establishes the right to withdraw at any time without any resulting detriment and without having to provide any justification. A consent form that conditions withdrawal on notice, on completion of procedures, or on any form of detriment is not compliant with Article 63 and will be flagged by the ethics committee.

**Which standard governs the informed consent procedure in practice?**
EN ISO 14155:2020+A11:2024 — Clinical investigation of medical devices for human subjects — Good clinical practice — operationalises the informed consent procedure for MDR clinical investigations. It specifies how the prior interview is conducted, how the subject is given time to consider, how the form is signed and filed, and how re-consent is handled when new information becomes available.

**Who should draft the informed consent form?**
The consent form should be drafted by the people who understand the device, the investigation, and the risks — typically the principal investigator and the sponsor medical lead, working from the risk management file and the investigator's brochure. A CRA, lawyer, or template service can review and format but cannot originate the content, because a copy-pasted form will not match the specific risks, benefits, and procedures of the investigation.

## Related reading

- [Ethical Approval for Clinical Investigations: Ethics Committee Requirements Under MDR](/blog/ethics-committee-clinical-investigations-mdr) — the committee that scrutinises the consent form and the dossier it sits inside.
- [MDR Chapter VI: Clinical Investigations — The Full Regulatory Framework](/blog/mdr-chapter-vi-clinical-investigations) — the article-by-article walkthrough of the chapter that houses Article 63.
- [What Is a Clinical Investigation Under MDR? When Your Startup Needs to Run a Study](/blog/what-is-clinical-investigation-mdr) — the definitional groundwork for sponsors deciding whether consent requirements apply.
- [Writing a Clinical Investigation Plan (CIP) Under MDR Article 62](/blog/write-clinical-investigation-plan-cip) — the CIP that the consent form must match for risk-benefit language and procedures.
- [Investigator's Brochure Under MDR Annex XV](/blog/investigators-brochure-mdr-annex-xv) — the source document the consent form's risk section must trace back to.

## Sources

1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, Article 62 (general requirements regarding clinical investigations), Article 63 (informed consent), Article 64 (clinical investigations on incapacitated subjects), Article 65 (clinical investigations on minors), Article 66 (clinical investigations on pregnant or breastfeeding women), Article 67 (additional national measures), Article 68 (clinical investigations in emergency situations), Annex XV (clinical investigations — documentation content). 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 drafting the informed consent materials for an MDR clinical investigation and want the form pressure-tested against Article 63, the vulnerable-subject provisions of Articles 64 to 68, and the ethics committee expectations of the member states where you will enrol, Zechmeister Strategic Solutions walks that drafting with founders — line by line, risk by risk, population by population, before the dossier reaches the committee.*

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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).*