---
title: MDR Article 62(4)(g): Financial Compensation and Insurance for Clinical Investigations
description: MDR Article 62(4)(g) requires sponsors to arrange financial compensation and insurance for clinical investigation subjects. Here is what that means in practice.
authors: Tibor Zechmeister, Felix Lenhard
category: Clinical Evaluation & Investigations
primary_keyword: clinical investigation insurance MDR Article 62
canonical_url: https://zechmeister-solutions.com/en/blog/clinical-investigation-financial-compensation-insurance
source: zechmeister-solutions.com
license: All rights reserved. Content may be cited with attribution and a link to the canonical URL.
---

# MDR Article 62(4)(g): Financial Compensation and Insurance for Clinical Investigations

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

> **MDR Article 62(4)(g) requires that before a clinical investigation may be authorised and begin, the sponsor has arranged financial compensation for subjects in the event of injury suffered as a consequence of participation in the investigation, either through an insurance policy or through an equivalent arrangement that covers the liability of the sponsor and the investigator. Article 69 of Regulation (EU) 2017/745 obliges Member States to ensure that systems for compensation for any damage suffered by a subject are in place, in the form of insurance, a guarantee, or a similar arrangement that is equivalent as regards its purpose and appropriate to the nature and extent of the risk. Annex XV Chapter II requires the clinical investigation plan to describe these arrangements. In practice, this means a startup sponsor must buy a specific clinical trial insurance policy — not general product liability, not general professional indemnity — sized to the Member State's rules and the study's risk profile, and have the certificate in hand before the competent authority application and the ethics committee submission go out.**

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

---

## TL;DR

- MDR Article 62(4)(g) makes subject compensation arrangements a pre-authorisation condition for every clinical investigation conducted to demonstrate conformity.
- MDR Article 69 requires each Member State to ensure a system for compensation for damage is in place — through insurance, guarantee, or equivalent arrangement proportionate to the risk.
- Annex XV Chapter II requires the clinical investigation plan to describe the insurance and compensation arrangements in writing.
- The required coverage is specific clinical trial insurance. General product liability and professional indemnity policies do not satisfy Article 62(4)(g) on their own.
- Coverage rules, minimum sums, and no-fault requirements are set at Member State level and differ significantly between countries where the investigation will run.
- A startup sponsor should price and bind the policy early — weeks before the Article 70 application, not after — because the certificate is part of the submission package.

---

## Why this is the article that surprises startup sponsors

Founders who read MDR Article 62 for the first time usually stop at the scientific requirements: scientific soundness, ethics approval, informed consent, sponsor obligations. Then they reach paragraph (4)(g) and realise that compensation and insurance are not a post-authorisation administrative task. They are a pre-authorisation condition. No insurance, no authorisation. No authorisation, no investigation. No investigation, no clinical evidence.

This catches sponsors who built their budget around patients, sites, monitors, and the clinical investigation plan itself, and who left insurance as a line item they would sort out "closer to the study." The policy itself is usually affordable relative to the rest of the study budget. The problem is never the cost. The problem is the timeline and the specificity of the cover. Clinical trial insurance for a medical device investigation is a niche product, underwriters ask detailed questions, brokers need the clinical investigation plan to quote, and the certificate has to name the specific sites, the specific Member State rules, and the specific sum assured that each national regime requires. A founder who starts this conversation two weeks before the Article 70 application will not have the certificate ready, and the application will not be submittable.

This post walks through what Article 62(4)(g) actually says, what Article 69 adds, how Annex XV ties it into the clinical investigation plan, how Member States vary, how to actually buy the cover, and the mistakes we see most often.

For the broader context of what a clinical investigation is and when one is required, see our post on [what a clinical investigation is under MDR](/blog/what-is-clinical-investigation-mdr). For the document this insurance certificate gets attached to, see [writing a clinical investigation plan under MDR Article 62](/blog/write-clinical-investigation-plan-cip).

## What MDR Article 62(4)(g) requires

Article 62(4) lists the cumulative conditions under which a clinical investigation may be conducted. Point (g) reads, in substance, that a clinical investigation may be conducted only where the subject — or, where the subject is not able to give informed consent, his or her legally designated representative — has been informed of the right to withdraw and where the sponsor has provided for compensation of subjects in the event of injury in accordance with the applicable national law through an insurance or an equivalent guarantee covering the liability of the sponsor and the investigator. (Regulation (EU) 2017/745, Article 62, paragraph 4, point (g).)

Four things follow from that sentence, and each one changes how the sponsor plans the investigation.

First, the requirement is a pre-condition of authorisation. The sponsor cannot start the investigation unless the arrangement is in place. The competent authority verifies it. The ethics committee verifies it. Without the evidence of cover, the application is incomplete.

Second, the arrangement must cover both the sponsor and the investigator. A policy that insures only the sponsor leaves the investigator — and therefore the site and the institution — exposed, which is the quickest way to have a site refuse to participate.

Third, the arrangement must be in the form of an insurance policy or an equivalent guarantee. Self-insurance by a two-person startup is not an equivalent guarantee. An equivalent guarantee in practice means a financial instrument that a regulator would accept as a real substitute for an insurance policy, and very few startups have access to one.

Fourth, the scope of cover is defined by "injury in accordance with the applicable national law." This is the crucial handoff from MDR to the Member State. Article 62(4)(g) does not tell you what a covered injury is. Article 69 and the national law of the Member State where the investigation runs do.

## What MDR Article 69 adds

Article 69 — titled damage compensation — obliges Member States to ensure that systems for compensation for any damage suffered by a subject as a result of participation in a clinical investigation conducted on their territory are in place in the form of insurance, a guarantee, or a similar arrangement that is equivalent as regards its purpose and which is appropriate to the nature and the extent of the risk.

Article 69 is the Member State–level rule that sits behind the sponsor obligation in Article 62(4)(g). It tells Member States: you must have a national compensation system; the sponsor must use it. It also introduces the principle of proportionality. The arrangement must be appropriate to the nature and the extent of the risk. A first-in-human investigation of a novel implantable device is not the same risk profile as a post-market usability study of a low-risk device, and Article 69 allows (indeed requires) the arrangement to scale with that difference.

Read together, Article 62(4)(g) and Article 69 mean the following for a sponsor: the insurance policy is not a generic product. It is tailored to the specific study, to the specific Member State's national regime, and to the specific risk the subject is actually exposed to.

## What the policy has to cover in practice

The policy must respond when a subject suffers injury as a consequence of participating in the investigation. In practical terms, the cover must include, at a minimum:

- Bodily injury, death, or health impairment of subjects arising from the investigation, whether caused by the device under investigation, by the procedures required by the clinical investigation plan, or by any other aspect of participation.
- The liability of the sponsor and of the investigator, as Article 62(4)(g) explicitly requires. Many national regimes also require cover for the institution hosting the investigation.
- Defence costs and legal expenses associated with claims.
- Compensation in line with the national law of each Member State where the investigation is conducted, including any statutory minimum sums, no-fault elements where required, and claims-reporting windows that can extend years after the end of the investigation.

The policy must not be limited to "device defects" or "manufacturing liability." Clinical investigation insurance is broader than product liability because the injury can arise from anything the subject is exposed to by virtue of being in the study — the device, the procedure, the follow-up visit, the imaging, the rescue medication, the investigator's action. A general product liability policy written for the manufacturer's commercial product is not, on its own, enough to satisfy Article 62(4)(g).

## No-fault compensation — the concept that changes the math

Several Member States require, either by statute or by regulator expectation, that the compensation arrangement be no-fault. No-fault compensation means the subject who suffers injury as a consequence of the investigation can be compensated without having to prove negligence by the sponsor or the investigator. It is enough to demonstrate the injury and the causal link to participation in the study.

For the sponsor, no-fault cover is usually more expensive and more demanding on policy wording than fault-based cover. For the subject, it is far more protective. For the Regulation, it fits the proportionality principle in Article 69 — the higher the inherent risk of participation, the stronger the compensation system must be.

A startup sponsor writing the clinical investigation plan under Annex XV Chapter II needs to know, before the broker is contacted, whether the Member States on the target list require no-fault cover. This determination is a legal question answered by national law in each country. Get it wrong and the policy you buy will not be accepted by the competent authority or the ethics committee in the country where it matters.

## Member State variation — the part that cannot be generalised

MDR harmonises the principle. Member States operate the compensation systems. The consequence for a sponsor running a multi-country investigation is that the insurance arrangement is not one policy sized to one rule. It is one policy that satisfies the strictest regime on the site list, or separate arrangements per country, or a combination — and the broker will need the country list before the quote can be written.

We do not list country-by-country minimum sums or rules in this post on purpose. They change, they are interpreted locally, and a founder who relies on a number from a blog post to size the cover will buy the wrong policy. The correct sequence is: finalise the country and site list, engage a broker who specialises in clinical trial cover in those countries, provide the draft clinical investigation plan so the underwriter can assess the risk, and let the broker confirm the exact requirements against each country's current rules. This is one of the specific moments where a regulatory advisor who has done multi-country MDR investigations before earns the fee — knowing which broker, in which country, writes this cover at startup scale and at sensible terms.

## How to obtain the cover — the practical sequence

The sequence that works for startup sponsors looks like this.

First, lock the scope. Intended purpose, device class, investigation type (first-in-human, confirmatory, post-market follow-up), number of subjects, number of sites, target countries, duration of subject participation, and follow-up window. Without these, no quote.

Second, draft the clinical investigation plan to the point where the design, endpoints, population, and procedures are stable. The underwriter needs this — not the final version, but a version that will not be rewritten the week before the application.

Third, engage a broker specialised in clinical trial insurance in the Member States where the investigation will run. This is not a general commercial broker. Ask the broker for references from other medical device sponsors and for evidence they have placed cover compliant with Article 62(4)(g) in the specific countries on your list.

Fourth, provide the broker with the draft clinical investigation plan, the draft investigator's brochure, the risk management file extract relevant to the investigation, and the list of sites and investigators. Expect underwriter questions on the risk file, the pre-clinical evidence, and the safety precautions in the clinical investigation plan.

Fifth, bind the policy and obtain the certificate. The certificate is what goes into the Article 70 application and the ethics committee submission. Annex XV Chapter II requires the clinical investigation plan itself to describe the compensation arrangements in writing — this is where the certificate details get reflected in the CIP text.

Sixth, keep the cover in force for the full duration of the investigation and for the tail period required by national law. Claims can arise years after the last subject visit. The policy tail matters.

## Common mistakes we see

**Assuming product liability is enough.** The general commercial product liability policy the startup already holds for its commercialised products does not, on its own, satisfy Article 62(4)(g). Clinical trial cover is a separate, more specific product.

**Leaving insurance to the last week.** Brokers need the clinical investigation plan and the risk file to quote. Underwriters take time to assess. Certificates specify Member States, sites, sums, and named insureds. Two weeks is not enough. Six to eight weeks before the planned Article 70 application is a safer working target.

**Buying cover that names only the sponsor.** Article 62(4)(g) requires cover for both the sponsor and the investigator. The policy has to reflect that — and many national regimes and institutional contracts additionally require the hosting institution to be named or covered.

**Ignoring the tail.** Claims can arise after the investigation ends. Clinical trial policies have reporting periods measured in years. Letting cover lapse the day the last subject visit closes is exactly how a preventable claim becomes a sponsor insolvency event.

**Using one country's minimum sum for a multi-country study.** The country with the highest requirement sets the floor for the whole study, not the country where the sponsor happens to be headquartered.

**Leaving the CIP text out of sync with the policy.** Annex XV Chapter II requires the clinical investigation plan to describe the compensation arrangements. The description in the CIP must match the certificate actually bound. Reviewers compare the two.

## The Subtract to Ship angle

[Subtract to Ship](/blog/subtract-to-ship-framework-mdr) applied to Article 62(4)(g) does not mean cutting cover. It means cutting everything around the cover that does not add protection. One specialised clinical trial policy that matches the strictest Member State regime on your site list, bound early, with the certificate in the Article 70 package and the wording reflected in the CIP — that is the minimum that works. Stacking three partial policies in the hope that together they satisfy the rule is exactly the kind of diligence-theatre the framework exists to strip out. A single correctly scoped policy is simpler to defend, simpler to administer, and simpler for the ethics committee and competent authority to read.

The subtraction happens on the surrounding noise: the generic liability coverage that does not respond to clinical trial risks, the draft quotes from non-specialist brokers that cannot actually place the business in the target countries, the internal debates about self-insurance that a two-person startup has no standing to conduct. Cut those. Keep the one policy that actually satisfies Article 62(4)(g), Article 69, and the Annex XV Chapter II description in the CIP.

## Reality Check — Where do you stand?

1. Have you read MDR Article 62(4)(g) in its current consolidated form and identified it explicitly as a pre-authorisation condition in your project plan?
2. Do you know which Member State or States your clinical investigation will run in, and have you confirmed the current national-law requirements for compensation and insurance in each?
3. Is your planned insurance arrangement specific clinical trial cover, not a general product liability or professional indemnity extension?
4. Does the policy you are quoting cover both the sponsor and the investigator, as Article 62(4)(g) explicitly requires?
5. Have you determined whether any of your Member States require no-fault compensation, and priced the cover accordingly?
6. Have you engaged a broker with documented experience placing clinical trial cover for medical device sponsors in your target countries?
7. Has the underwriter seen the current draft of the clinical investigation plan and the relevant risk management file extract, and are their questions answered?
8. Will the certificate be in hand in time to be part of the Article 70 application and the ethics committee submission — with a buffer, not on the day of?
9. Does the insurance and compensation section of your clinical investigation plan match the policy you have actually bound, word for word where it matters?
10. Does the policy tail extend far enough into the post-investigation period to cover claims that arise after the last subject visit?

## Frequently Asked Questions

**What does MDR Article 62(4)(g) require for insurance and compensation?**
MDR Article 62(4)(g) requires that before a clinical investigation conducted to demonstrate conformity may take place, the sponsor has arranged compensation for subjects in the event of injury suffered as a consequence of participation, through an insurance policy or an equivalent guarantee covering the liability of the sponsor and the investigator. The requirement is a pre-condition of authorisation, not a post-authorisation task. (Regulation (EU) 2017/745, Article 62, paragraph 4, point (g).)

**Is general product liability insurance enough to satisfy Article 62(4)(g)?**
No. Clinical trial insurance is a specific product that responds to injury suffered by subjects as a consequence of participation in the investigation — including injury caused by the device, by the protocol-required procedures, and by other aspects of the study. A general product liability policy written for the sponsor's commercialised product does not, on its own, cover the range of exposures created by a clinical investigation.

**What is the difference between Article 62(4)(g) and Article 69?**
Article 62(4)(g) places the obligation on the sponsor to have compensation arrangements in place before the investigation may take place. Article 69 places the obligation on the Member State to ensure that compensation systems — insurance, guarantees, or equivalent arrangements appropriate to the nature and extent of the risk — exist on its territory. Together they create a two-sided system: the Member State sets the rules, and the sponsor must comply with them for each country where the investigation runs.

**Does the insurance have to be no-fault?**
It depends on the Member State. Some national compensation regimes require no-fault cover, meaning a subject who suffers injury as a consequence of the investigation can be compensated without proving negligence. Others operate on a fault basis. The sponsor must determine the rule in each Member State where the investigation will run, because the correct answer drives both the policy wording and the premium.

**When should the sponsor buy the policy?**
Well before the Article 70 application and the ethics committee submission. The certificate is part of the submission package, and the CIP under Annex XV Chapter II must describe the arrangements. Underwriters need the draft clinical investigation plan and the risk file to quote, and specialist brokers take weeks, not days, to bind cover in niche markets. Six to eight weeks before the planned application is a safer working target than the week of.

**Does the policy have to cover the investigator as well as the sponsor?**
Yes. Article 62(4)(g) explicitly requires the arrangement to cover the liability of the sponsor and the investigator. In many national regimes and institutional contracts, the hosting institution also needs to be named or covered. A policy that protects only the sponsor is not compliant with Article 62(4)(g) and will not be accepted by investigators who understand the risk they are taking on.

**Where is the compensation arrangement documented in the clinical investigation plan?**
Annex XV Chapter II of the MDR requires the clinical investigation plan to describe the arrangements for compensation and insurance. The description in the CIP must match the certificate that has actually been bound — reviewers at the competent authority and the ethics committee compare the two, and a mismatch is a finding.

## Related reading

- [What Is a Clinical Investigation Under MDR?](/blog/what-is-clinical-investigation-mdr) — the framing post for when a clinical investigation is required and when it is not.
- [Do You Need a Clinical Investigation? The MDR Decision Tree](/blog/do-you-need-clinical-investigation-mdr-decision-tree) — the decision path that precedes insurance planning.
- [MDR Article 62 General Requirements for Clinical Investigations](/blog/mdr-article-62-general-requirements) — the article-by-article treatment of the provision this post drills into.
- [Writing a Clinical Investigation Plan (CIP) Under MDR Article 62](/blog/write-clinical-investigation-plan-cip) — the document the insurance certificate is referenced in.
- [How to Design a Clinical Investigation as a Startup](/blog/design-clinical-investigation-startup) — the design work that drives the risk profile the underwriter will price.
- [Competent Authority Application Under MDR Article 70](/blog/competent-authority-application-mdr-article-70) — the submission package the certificate is part of.
- [Ethics Committee Submission for MDR Clinical Investigations](/blog/ethics-committee-submission-mdr-clinical-investigations) — the second review stream that requires evidence of cover.
- [Sponsor Obligations Under MDR Articles 62 and 72](/blog/sponsor-obligations-mdr) — the accountability layer around the insurance obligation.
- [The Subtract to Ship Framework for MDR Compliance](/blog/subtract-to-ship-framework-mdr) — the methodology behind the scoping discipline in this post.

## 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 conducted to demonstrate conformity of devices), Article 62(4)(g) (compensation and insurance as a pre-condition of authorisation), Article 69 (damage compensation — Member State obligation), Annex XV Chapter II (content of the clinical investigation plan, including description of compensation arrangements). 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.

---

*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 sizing the insurance arrangement for a clinical investigation under MDR Article 62(4)(g) and want a sparring partner who has placed this cover before in the specific Member States on your site list, Zechmeister Strategic Solutions works with founders at exactly that moment — after the clinical investigation plan is drafted, before the broker conversation goes live.*

---

*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).*