Under MDR Article 7, manufacturers are prohibited from using text, names, trademarks, pictures, and figurative or other signs that may mislead the user or patient about the device's intended purpose, safety, or performance. In practice this means every marketing claim must stay inside the boundary drawn by the intended purpose in the technical documentation and substantiated by the clinical evaluation. If the website says more than the technical file supports, the website is the nonconformity.

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

TL;DR

  • MDR Article 7 prohibits misleading text, names, trademarks, pictures, and signs in relation to a device's intended purpose, safety, or performance.
  • Marketing claims are not a separate domain from the technical file. They are part of it. Every public claim has to be traceable to the intended purpose, the clinical evaluation, and the technical documentation.
  • The claims hierarchy runs top down: intended purpose defines the boundary, clinical evaluation substantiates, technical documentation captures, labelling and IFU communicate, marketing reflects. Marketing is the last link, never the first.
  • Startups drift into misleading claims on LinkedIn posts, press releases, pitch decks, demo videos, and landing-page copy. Usually without realising the marketing moved beyond the certified scope.
  • A mismatch between marketing and the technical file is a nonconformity during audit and can trigger competent authority enforcement. The cheapest fix is to prevent it; the next-cheapest is to reduce the website; the most expensive is to reopen the conformity assessment.

Why this matters. The website that said too much

A company Tibor worked with had passed initial review and was deep into the conformity assessment process. The device was solid, the technical file was in good shape, the clinical evaluation substantiated the intended purpose as written. Then the auditor opened the website in a browser tab and started reading.

The website was the problem. Marketing had added claims over the months. Phrases that sounded good in pitch decks, benefits that testers had mentioned in feedback, outcomes that customers had reported informally. None of it was outrageous. None of it was invented. But several claims went beyond what the conformity assessment actually covered. The intended purpose in the technical documentation said one thing; the website said that thing plus a handful of extra benefits that had never been evaluated clinically and never been captured in the technical file.

The nonconformity was raised against the marketing. Not against the device. The device was fine. The marketing had drifted past what the technical documentation could defend, and under MDR Article 7 that is a compliance failure in its own right. The fix was not to add more clinical work. The fix was to reduce the website to claims the technical file could support, line by line, until every public statement was inside the certified scope.

This is the pattern Tibor sees most often with misleading claims under MDR. Not intentional deception. Marketing drift. A founder, a growth marketer, a sales lead, and a website copywriter each adding language over time, each small addition defensible in isolation, the cumulative result outside the boundary the regulation draws.

What Article 7 actually prohibits

MDR Article 7 is short, specific, and absolute. It 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 regards the device's intended purpose, safety, or performance. It prohibits attributing functions and properties which the device does not have. It prohibits creating a false impression regarding treatment or diagnosis, functions, or properties which the device does not have. It prohibits failing to inform the user or patient of a likely risk associated with the use of the device in line with its intended purpose. And it prohibits suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out. (Regulation (EU) 2017/745, Article 7.)

Each of those clauses matters independently. A startup can stay within the intended purpose on the product page and still violate Article 7 by using an image that implies a function the device does not have, or by posting a testimonial that creates a false impression of performance, or by omitting a risk that is in the IFU but absent from the sales pitch.

Article 7 applies to labelling, IFU, and advertising. Advertising is defined broadly in practice. It covers the website, press releases, trade show booths, product brochures, investor decks if they are public, LinkedIn posts from the company page, sales emails to potential buyers, demo videos, explainer videos, and conference talks where the product is shown. If a prospective user or patient could see it and form an impression of the device, it is in scope.

The claims hierarchy. How the regulation builds the boundary

Claims under MDR are not a free-standing category. They sit at the bottom of a hierarchy that starts with the intended purpose and works outward through clinical evaluation, technical documentation, labelling, IFU, and finally public communication.

The hierarchy runs like this.

Intended purpose. 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." (Regulation (EU) 2017/745, Article 2(12).) Read that definition carefully. It explicitly includes promotional and sales materials in the definition of intended purpose. What you say in your marketing is not separate from the intended purpose. It is one of the inputs that define it. If the website says the device does X, the regulator can treat X as part of the intended purpose, and the technical file had better support it.

Clinical evaluation. Annex XIV Part A requires the manufacturer to plan, conduct, and document a clinical evaluation that demonstrates conformity with the general safety and performance requirements relevant to the intended purpose. (Regulation (EU) 2017/745, Annex XIV, Part A.) Every claim about clinical benefit, diagnostic accuracy, therapeutic outcome, or performance has to be substantiated here. A claim that is not substantiated in the clinical evaluation cannot appear downstream.

Technical documentation. Annex II of the MDR sets out the structure of the technical documentation, which captures the intended purpose, the clinical evaluation, the risk management file, the verification and validation evidence, and everything that supports the conformity assessment. If a claim cannot be traced into the technical documentation, it does not exist as a regulatory matter.

Labelling and IFU. Annex I Chapter III governs the information supplied with the device. The label and the instructions for use. And requires that information to be clear, accurate, and complete for the device's intended users. (Regulation (EU) 2017/745, Annex I, Chapter III.) The labelling and IFU are the manufacturer's formal communication to the user about what the device is, what it does, and how to use it safely.

Advertising and marketing. The website, press releases, brochures, demo videos, LinkedIn content, and sales materials are the last link in the chain. Everything they say has to be already present, and already substantiated, in the layers above.

The rule that makes this tractable is simple. Marketing must be a strict subset of the labelling, IFU, and technical documentation. Never a superset. The moment marketing contains a claim that is not in the technical file, Article 7 is in play.

Why marketing must be a subset of the technical documentation

The one-line version of the rule: if it is not in the technical file, it cannot be in the marketing. The technical file sets the outer boundary; the marketing can fill any part of that boundary but cannot extend past it.

This inversion is the single most useful mental model for claims compliance under MDR. Startups instinctively do the opposite. They write marketing first. The copywriter drafts a landing page, the founder writes a LinkedIn post, the CEO gives a conference talk. And then someone on the regulatory side tries to retrofit the technical documentation to catch up. That sequence always loses. The marketing outruns the evidence, the technical file cannot stretch to cover it, and the auditor finds the gap.

The Subtract to Ship move is to reverse the sequence. Define the intended purpose first, substantiate it in the clinical evaluation, capture it in the technical documentation, fix the labelling and IFU to match, and only then write marketing that stays inside the boundary. When marketing is derived from the technical file rather than invented independently of it, misleading claims become structurally unlikely. The copywriter is not deciding what the product does. The technical file is. The copywriter is deciding how to say it in a way that a real user will understand.

How startups drift into misleading claims without noticing

In every case Tibor has seen, the drift into misleading claims was not deliberate. It was a series of small, separately defensible additions that added up to a public statement outside the certified scope.

The common entry points.

LinkedIn posts. Someone at the company writes a post celebrating a customer outcome. The outcome is real. The attribution of the outcome to a specific device function is an implicit performance claim. If that function is not in the intended purpose, the post is a misleading claim.

Press releases. A launch press release is drafted by a marketing agency that has never read the technical file. The agency knows how to write compelling product copy. It does not know the difference between a certified claim and a generic industry claim. Phrases slip in that sound standard but are not substantiated.

Pitch decks. Investor pitches often exaggerate modestly. "the product does X" where "X" is aspirational roadmap rather than certified function. Pitch decks that end up on the public internet or are emailed to large investor lists become advertising in the MDR sense.

Demo videos. A demo video shows the product in use. The voice-over describes what the viewer is seeing. If the voice-over describes a function that is not in the IFU, the video is a misleading claim. Videos are high-risk because they are evocative and memorable; a single inaccurate sentence lives in many viewers' heads.

Landing-page copy A/B tests. Growth teams iterate headlines to maximise conversion. Each variant is a public claim. Headlines that win conversion tests are often the ones that promise the most. And those are the ones most likely to step outside the intended purpose.

Testimonials. A customer writes a glowing testimonial. The testimonial attributes outcomes to the device that are not in the clinical evaluation. Publishing the testimonial without editing it to stay within the certified scope makes those attributions part of the manufacturer's advertising.

Conference talks. A founder gives a conference talk with slides that go beyond the IFU. The slides are shared on social afterwards. The talk becomes advertising.

In each case, the fix is not to stop doing marketing. It is to build a checkpoint where every public claim is matched against the intended purpose and the clinical evaluation before it ships.

The cost of a mismatch

A mismatch between marketing and the technical file is expensive on three fronts.

During notified body audit, the auditor can and will check public-facing materials. If claims on the website do not match the technical documentation, a nonconformity is raised. The resolution is either to reduce the marketing or to extend the technical documentation and the clinical evaluation. And extending the evidence base is almost always the slower and more expensive path.

Under competent authority enforcement, misleading claims can trigger corrective action, withdrawal from the market, and in serious cases fines and public enforcement records. Article 7 is enforceable law, not guidance. Competent authorities monitor advertising and can act on complaints from competitors, users, or patient organisations.

For Class III devices and implantables, the Summary of Safety and Clinical Performance under MDR Article 32 is a public-facing document written specifically to communicate the device's intended purpose, indications, contraindications, and clinical performance to patients and users. (Regulation (EU) 2017/745, Article 32.) The SSCP is the anchor public claims document for these devices, and marketing that contradicts the SSCP is straightforwardly misleading by the regulation's own logic.

Beyond the regulatory cost, there is a reputational cost that is harder to quantify but often larger. Medical device buyers. Clinicians, hospital procurement teams, reimbursement bodies. Read the IFU. When the IFU and the website disagree, trust drops. A buyer who catches the discrepancy will not ask for an explanation. They will move on.

How to keep marketing aligned. The Subtract to Ship angle

The Subtract to Ship approach to claims compliance is mechanical, repeatable, and cheap once set up.

The framework runs as four checks before any public claim ships.

Check 1. Is this claim in the intended purpose? Open the intended purpose statement in the technical file. Read the claim. If the claim is not present. Either literally or as a direct consequence. The claim does not ship.

Check 2. Is this claim substantiated in the clinical evaluation? Open the clinical evaluation report. Find the evidence for the claim. If the evidence is not there, the claim does not ship.

Check 3. Does this claim match the labelling and IFU? Open the current IFU. Confirm the wording is consistent. If the IFU says the device is indicated for A and the marketing says A and B, the B does not ship.

Check 4. Would the auditor find this acceptable if they read it next to the technical file? Imagine the auditor reading the public claim with the technical file open. If you would be comfortable defending the match, the claim ships. If not, it does not.

This is the subtraction move. Instead of writing marketing first and scrambling to justify it later, the marketing is derived from the certified scope. Everything that does not pass the four checks is cut. What remains is defensible by construction.

Practically, this means one person. Usually the PRRC or a delegated regulatory reviewer. Signs off on every public claim before it goes live. That person has the technical file open and the marketing copy open and checks them against each other. The cost is small. An hour a week in most startups. And it prevents the cascade of nonconformities that marketing drift produces.

Reality Check. Where do you stand?

  1. Does someone at your company read every public-facing claim against the intended purpose before it ships, and is that person named and empowered?
  2. Can you show, for every claim on your website, which section of the technical documentation substantiates it?
  3. When did you last audit your LinkedIn posts, press releases, demo videos, and sales decks for claims that exceed the certified scope?
  4. Does your marketing agency or copywriter have access to the intended purpose statement and the IFU before they write?
  5. If a notified body auditor opened your website during an audit, which claims would you be least comfortable defending?
  6. For Class III or implantable devices, does your marketing match the SSCP word-for-word on intended purpose, indications, and contraindications?
  7. Have you drawn a visible line inside the company between "things the product does today that are certified" and "things the product might do in the future". And do your public channels respect the line?

Frequently Asked Questions

Is my LinkedIn post considered advertising under MDR Article 7? Yes, if the post is from the company page or from an employee in their professional capacity and describes the product in a way that could influence a user or patient's perception of it, it counts as advertising for Article 7 purposes. The regulation does not distinguish between a website and a social post. It applies to any text or image that may mislead the user or patient about the device.

Can I make claims in a pitch deck that go beyond the certified intended purpose? Not if the pitch deck is public or circulated broadly. Investor-only decks shared under NDA are in a grey area that depends on the audience and distribution, but any pitch deck that reaches public view or is shared widely online becomes advertising and must stay within the certified scope.

What happens if my marketing says more than my technical file supports? If a notified body auditor finds it during audit, a nonconformity is raised and you will be required to either reduce the marketing or extend the technical documentation. If a competent authority finds it, enforcement action is possible, up to market withdrawal and fines. The cheapest resolution is almost always to reduce the marketing to match the technical file.

Can I promote off-label uses if customers are using the device that way? No. Article 7 explicitly prohibits suggesting uses other than those stated to form part of the intended purpose for which the conformity assessment was carried out. If the use is not in the intended purpose, you cannot promote it. Even if customers are doing it spontaneously.

Who is responsible inside a startup for making sure marketing claims are compliant? The manufacturer is responsible under MDR. In practice, the Person Responsible for Regulatory Compliance under Article 15 is the natural reviewer, but the legal responsibility sits with the manufacturer as a whole. Whoever signs off on public claims should have access to the technical file and the authority to block or edit marketing that steps outside the certified scope.

What is the SSCP and how does it relate to marketing? The Summary of Safety and Clinical Performance under MDR Article 32 is required for Class III and implantable devices. It is a public document that summarises the intended purpose, indications, contraindications, and clinical performance for patients and users. Marketing for these devices must be consistent with the SSCP. Any claim that contradicts the SSCP is misleading by definition.

Sources

  1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, Article 7 (claims), Article 2(12) (intended purpose), Article 32 (Summary of Safety and Clinical Performance), Annex I Chapter III (information supplied with the device), Annex XIV Part A (clinical evaluation). Official Journal L 117, 5.5.2017.

This post is part of the Technical Documentation & Labeling series in the Subtract to Ship: MDR blog. Authored by Felix Lenhard and Tibor Zechmeister. Claims compliance is where many startups first meet the enforcement edge of the MDR. Usually after they have already said too much. The fix is structural: derive the marketing from the technical file, not the other way around.