Crowdfunding rarely works for regulated medical devices under the MDR. Article 7 prohibits misleading claims and attributes functions the device does not have, which is exactly what a crowdfunding pitch is designed to do. Article 5 prohibits making the device available before CE marking, which is what a pre-order effectively does. Equity crowdfunding is the one path that can work, because it funds the company rather than pre-selling the device.

By Tibor Zechmeister and Felix Lenhard.

TL;DR

  • Reward-based crowdfunding (Kickstarter, Indiegogo) for an uncertified medical device is almost always a legal trap. The pitch content triggers MDR Article 7; the pre-order mechanics brush against Article 5.
  • MDR Article 7 prohibits text, names, trademarks, pictures, and figurative or other signs that may mislead the user or patient regarding the device's intended purpose, safety, or performance. A crowdfunding campaign's hero video is exactly the kind of content Article 7 scrutinises.
  • Article 5 prohibits placing a device on the market before CE marking. Accepting money today for delivery of a device after certification looks like placing on the market to competent authorities, even if the word "pre-order" is used.
  • Equity crowdfunding — where backers buy shares in the company, not the device — is a legitimate path because it funds the manufacturer, not the device sale.
  • The intended purpose stated in a crowdfunding campaign effectively freezes your device's future regulatory path. Public claims made in a campaign become part of the evidence your notified body will eventually review.

Why this matters

Crowdfunding is seductive for early-stage MedTech founders. It promises non-dilutive capital, market validation, and a built-in community of early adopters. The model has worked spectacularly for consumer hardware, fitness wearables, and design products. The natural question: why not medical devices?

The answer is not that the MDR contains an explicit ban on crowdfunding. It does not. The answer is that the mechanics of a reward-based crowdfunding campaign collide with two of the MDR's most fundamental rules — Article 5 on market placement and Article 7 on promotional claims — in ways that are difficult to avoid. Most campaigns that try end up either (a) breaking the rules and facing enforcement, or (b) so heavily sanitised that they fail to attract backers.

This post explains what the MDR actually says, where the specific traps are, and which crowdfunding variants can work. It is written from the perspective of a notified body auditor who has seen founders walk into this wall more than once.

What MDR actually says

Article 5(1) — Placing on the market and putting into service. A device may be placed on the market or put into service only if it complies with the MDR. "Placing on the market" is defined in Article 2(28) as the first making available of a device on the Union market. "Making available" is defined in Article 2(27) as any supply of a device for distribution, consumption, or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge.

A pre-order that collects money today in exchange for a promise to deliver a device tomorrow is commercial activity. The supply occurs at delivery — so the legal violation crystallises when the device ships, not when the money is collected. But the promotional material promising that supply runs into Article 7 immediately.

Article 7 — Claims. This is the provision that closes the door on most reward-based crowdfunding campaigns. Article 7 prohibits, in the labelling, instructions for use, making available, putting into service, and advertising of devices, the use of text, names, trademarks, pictures, and figurative or other signs that may mislead the user or the patient as to the device's intended purpose, safety, or performance by:

  • attributing functions and properties to the device which it does not have,
  • creating a false impression regarding treatment or diagnosis, functions, or properties which the device does not have,
  • failing to inform the user or patient of a likely risk associated with the use of the device,
  • suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.

The last point is crucial. A device that has not yet undergone conformity assessment cannot have advertising that suggests uses consistent with a certified intended purpose — because there is no certified intended purpose yet. Any claim about what the device does is made in the absence of the regulatory verification that would normally support it.

Intended purpose freezing. MDR Article 2(12) defines intended purpose as the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation. Promotional materials are explicitly inside the definition. That means the claims in your crowdfunding campaign become part of the evidence establishing the device's intended purpose — and your notified body will, during the conformity assessment, look at the consistency between those public claims and the device as designed, tested, and documented.

Article 120 — Transitional provisions. The crowdfunding question does not change under the transitional provisions extended by Regulation (EU) 2023/607. Article 5 and Article 7 apply regardless of which certification pathway or timeline the device is on.

A worked example

A Berlin startup is developing a wearable device that monitors atrial fibrillation. The device is Class IIa. CE marking is twelve months out. The founders plan a Kickstarter campaign targeting EUR 500,000 from approximately 3,000 backers.

The draft campaign page says: "Our device detects atrial fibrillation with 95 percent accuracy, helping you catch dangerous heart rhythm problems before they cause a stroke." Backers who pledge EUR 199 will receive a device at the end of the campaign period, estimated delivery in nine months.

This campaign violates the MDR in three distinct ways:

First, the accuracy claim. The 95 percent figure comes from internal validation testing, not from a CE-marked device with a completed clinical evaluation. Article 7 prohibits attributing functions or properties to the device unless supported by the evidence the conformity assessment requires. Publishing the claim before that assessment is complete is misleading by the MDR's own definition.

Second, the intended purpose lock-in. By publicly stating that the device "detects atrial fibrillation," the founders are establishing an intended purpose that the notified body will scrutinise during the conformity assessment. Every clinical data point, every risk analysis, every label element will be measured against that claim. If the evidence does not fully support "95 percent accuracy for AFib detection," the CE marking will be delayed or denied — and the founders will have collected money from 3,000 backers for a device they cannot legally deliver.

Third, the pre-order mechanics. Delivery in nine months, before CE marking, would require placing an uncertified device on the market. That is prohibited by Article 5. Even if delivery is delayed until after CE marking, the transaction — payment today for a device tomorrow — will be examined by competent authorities as a commercial arrangement made for an uncertified device at the time of sale. Some authorities will treat this as acceptable if delivery is genuinely contingent on CE marking; others will not. The legal uncertainty alone makes this a poor foundation for a funded company.

A legally cleaner version of the campaign would: describe the problem (AFib prevalence, stroke risk) without making device performance claims, describe the company's mission and development status, state clearly that the device is under development and will require CE marking before delivery, and structure the backer contribution as an equity investment or a donation with no device delivery commitment.

Alternatively, the founders can raise equity crowdfunding through a platform like Seedrs or Companisto, where backers buy shares in the company rather than pre-ordering a device. That path avoids Article 5 entirely because no device transaction occurs.

The Subtract to Ship playbook

1. Default position: reward-based crowdfunding is not for medical devices. Start from the assumption that Kickstarter-style campaigns are not a viable path for a CE-regulated device. The burden of proof is on the founder to show that a specific variant avoids both Article 5 and Article 7. Most cannot.

2. If you crowdfund, crowdfund equity. Equity crowdfunding platforms exist in most European jurisdictions — Seedrs, Crowdcube, Companisto, FundedByMe, among others. Backers purchase shares in the company under prospectus exemptions or similar regimes. This is legally equivalent to raising seed capital from many small investors. No device is being sold, no pre-order is being accepted, and Article 5 is not triggered.

3. Even equity crowdfunding is not free of Article 7. A campaign page promoting the company is also, indirectly, promoting the device. Article 7 applies to promotional material regardless of the transaction type. Keep device claims vague, factual, and unambitious. Describe the problem being addressed, the team, the regulatory pathway, and the clinical rationale — not specific performance numbers you cannot yet substantiate.

4. Avoid framing the investment opportunity around device sales projections. The standard equity crowdfunding pitch emphasises market size, revenue projections, and expected returns. For a pre-CE device, those projections implicitly claim the device will perform as described and will receive CE marking on schedule. Both claims are uncertain, and aggressive framing invites scrutiny from competent authorities who may view the entire campaign as indirect promotion of an uncertified device.

5. Coordinate the campaign with your notified body — or at least anticipate what they will see. Whatever you publish will be visible to your future notified body auditors. Some auditors will check past press coverage, archived campaign pages, and social media. A campaign that contradicts the intended purpose in your technical file, or that made claims you cannot support with clinical evidence, will come up during the audit. Write every public word with that audit in mind.

6. Do not use pre-orders, deposits, or conditional purchases. Every variant of "pay today, receive later" for an uncertified device carries legal risk. Even if the money is refundable and the delivery is explicitly contingent on CE marking, the arrangement creates commitments that will be scrutinised. Non-dilutive funding that does not involve promising a device is always safer.

7. Consider non-dilutive grants instead. European and national grant programmes — EIC Accelerator, Horizon Europe, national innovation agencies — exist precisely to fund the pre-CE phase of MedTech development. Grant funding is slow and administratively heavy, but it is legally clean and does not create promotional obligations.

8. Write every campaign sentence as if a regulator will read it — because one might. Competent authorities monitor crowdfunding platforms, particularly after complaints from competitors or disappointed backers. A campaign that attracts attention also attracts scrutiny. Treat every sentence as if it were part of your technical file, because indirectly, it is.

Reality Check

  • Can you describe your campaign plan without using any specific performance claims about the device?
  • Does any part of the campaign mechanics involve money flowing in exchange for a future device, even with refundable deposits or conditional delivery?
  • If the campaign is equity-based, have you confirmed compliance with your jurisdiction's prospectus rules and the crowdfunding regulation (EU 2020/1503)?
  • Have you written down the intended purpose statement you are willing to live with for the next ten years — because public campaign statements effectively freeze it?
  • Does your campaign text avoid claims that attribute functions or safety characteristics the device has not yet been tested for?
  • Would your notified body auditor be comfortable reading your campaign page word-for-word next to your technical file?
  • Have you considered non-dilutive grants as a safer alternative for the same capital amount?
  • Do you have legal counsel familiar with both crowdfunding regulation and medical device law reviewing the campaign before launch?

Frequently Asked Questions

Can we do a Kickstarter if we wait to deliver the device until after CE marking? It is less risky but not risk-free. Article 7 still applies to the campaign content, and any promotional claims about the device's performance made during the campaign become evidence during the conformity assessment. Competent authorities in some member states have taken action against campaigns of this type. Legal review is essential.

What about a "wellness version" of the device that does not require CE marking? This is the two-phase approach — launching a non-medical wellness product first, then developing a regulated medical device in parallel. The wellness product can be crowdfunded because it is not a medical device. The catch is that the wellness product must genuinely not make medical claims, and the boundary between wellness and medical is narrow. If the crowdfunding campaign leaks medical claims onto the wellness product, you have created a borderline or an illegally marketed medical device.

Is equity crowdfunding under EU Regulation 2020/1503 different from reward-based crowdfunding? Yes, fundamentally. Equity crowdfunding is a regulated investment activity. Backers buy securities, not devices. The regulation applies to the investment offering, not to the device. MDR Article 5 is not triggered because no device sale occurs.

Can we accept donations from supporters to fund development? Yes, donations with no device delivery commitment are legally clean under the MDR. Charitable donations, patron-style support, and sponsorship contributions are not device sales. The risk is that the tax and solicitation rules governing donations vary widely between member states.

What if a backer receives a non-medical thank-you item instead of the device? That works, if the thank-you item is genuinely unrelated to the medical function. A branded t-shirt, a thank-you letter, a name in the credits — none of these trigger MDR obligations. The moment the reward is the device itself, or anything that functions as the device, you are back in Article 5 territory.

Has any European MedTech successfully crowdfunded a medical device? A few have tried; most have run into regulatory issues or restructured the campaign. The more durable examples are companies that used equity crowdfunding to fund the manufacturer rather than the device, or that crowdfunded a non-medical wellness precursor to the eventual device.

Sources

  1. Regulation (EU) 2017/745 on medical devices, consolidated text. Articles 2, 5, 7, 120.
  2. Regulation (EU) 2020/1503 on European crowdfunding service providers for business.