Under MDR Article 7, every claim a manufacturer makes about a medical device. On a website, in a brochure, in a sales deck, in an IFU. Must stay inside the intended purpose for which the conformity assessment was carried out, and must be substantiated by the technical documentation and the clinical evaluation. Claims management is the process of tracking every public claim in a single register, linking each one to its evidence source, and refusing to publish any claim that does not trace to something inside the file. "Clinically proven" is not a sentence you get to write. It is a sentence you get to justify.

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

TL;DR

  • MDR Article 7 prohibits any claim that misleads a user or patient about a device's intended purpose, clinical benefits, safety, or performance. Across labelling, IFU, advertising, and all other communication.
  • MDR Article 2(12) defines the intended purpose as including the data supplied by the manufacturer in promotional and sales materials, which pulls every public claim into the regulated scope.
  • A claim is compliant only when the technical documentation and the clinical evaluation support it in the exact wording used. "Clinically proven" without specific, substantiated evidence is misleading by default.
  • Claims management is a register-based discipline: every claim listed, linked to its evidence, approved by a named reviewer, and re-verified on every change to the product or file.
  • The cheapest time to catch an overreaching claim is before it is written. The most expensive time is during a Notified Body audit reading the website next to the CER.

The founder's favourite sentence

Every founder wants to write the same sentence. It goes something like this: "Clinically proven to improve patient outcomes." Six words, strong verbs, a benefit, the word "clinically." It lands in pitch decks, on the homepage, in the first line of the sales email. It is the sentence the marketing consultant produces in the first workshop and the sentence the CEO approves in the first review.

It is also almost always non-compliant.

"Clinically proven" is a specific claim with a specific meaning. Under MDR it implies that the device has clinical evidence, in the Article 61 sense, that substantiates a defined clinical benefit in a defined patient population under defined conditions. "Improve patient outcomes" is a claim of clinical benefit. Together they assert that the clinical evaluation has demonstrated benefit. And unless the CER actually contains that demonstration with that wording, the sentence is a misleading claim under Article 7.

The first time most founders hear this, they think it is a technicality. It is not. It is the load-bearing example of how claims management works under MDR. The regulation does not ask whether the sentence is true in the ordinary-language sense. It asks whether the technical file supports the sentence in the exact form it reaches the user. Most founder sentences fail that test, and the ones that pass have been through a claims register.

What Article 7 actually prohibits

MDR Article 7 is the single claims rule for the whole regulation. It applies to labelling, instructions for use, making available, putting into service, and advertising of devices. (Regulation (EU) 2017/745, Article 7.)

Article 7 prohibits four things. Text, names, trademarks, pictures, or figurative signs that may mislead the user or the patient regarding the device's intended purpose, safety, or performance. Attributing functions and properties to the device which the device does not have. Creating a false impression regarding treatment or diagnosis, or functions or properties the device does not have, or failing to inform the user or patient of a likely risk associated with the use of the device in line with its intended purpose. 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.)

Read in the context of claims management, the pattern is clear. Every claim must do three things at once: stay inside the intended purpose, not attribute functions or properties the device does not have, and not omit any likely risk associated with use. A claim that is technically accurate about one property can still fail Article 7 by omitting a material risk or by implying a function outside the certified scope.

The Article 2(12) trap

This is the part founders miss. The MDR definition of intended purpose pulls promotional material into the regulated scope by construction. 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).)

The definition explicitly names promotional and sales materials as one of the sources of the intended purpose. Which means if the website says the device does X, the regulator treats X as part of what the manufacturer is claiming the device is for. The next question is whether the clinical evaluation and the technical documentation support X. If yes, the claim is fine. If no, the claim has either (a) overreached the certified intended purpose, making the promotional material non-compliant, or (b) quietly expanded the intended purpose beyond what the conformity assessment covered, which is a worse problem because now the certificate no longer covers what the manufacturer is placing on the market.

Claims management is the discipline that prevents both outcomes.

The claim audit. Green, yellow, red

The cleanest way to explain this in a workshop is to run a live claim audit. Pick any sentence from the website and colour-code it.

Green claims trace directly to the intended purpose, the IFU, and the clinical evaluation, in the same wording. "Designed for use by trained clinicians in a hospital setting". If that is what the intended purpose statement says, and the IFU says the same, and the CER evaluates the device in that context, the sentence is green. It can ship.

"Measures heart rate continuously with ±2 bpm accuracy in the 40–200 bpm range under resting conditions" is green if the performance evaluation in the technical file substantiates that specification with those numbers and those conditions. The sentence is a subset of the file.

Yellow claims are in the neighbourhood of the file but use language the file does not. "Easy to use" is yellow. The file probably has usability evaluation data under EN 62366-1:2015 + A1:2020, but "easy" is not a defined term and can mislead about training requirements. "Trusted by clinicians worldwide" is yellow. It is a vague social-proof claim, not a performance claim, but the word "worldwide" can imply regulatory approval in jurisdictions where the device is not registered. Yellow claims need rewriting before they ship. Either tighten the language to match the file, drop it, or add the qualifier that makes it accurate.

Red claims assert something the file does not support. "Clinically proven to improve outcomes" without a CER that demonstrates the specific outcome improvement. "The only device of its kind" without a substantiated market analysis. "Faster than leading competitors" without head-to-head data. "Reduces hospital readmission rates by 30%" without a clinical study that shows exactly that, for exactly the population the device is intended for. Red claims cannot ship. Full stop. The response is either to remove the claim or to generate the evidence that substantiates it. And generating new clinical evidence means updating the CER, which goes through the notified body.

A typical early-stage website has roughly 60% green, 30% yellow, 10% red. The first pass of a claims audit catches the red ones immediately. The yellows take longer because each one requires a judgement call about whether the wording is defensible. The exercise is not elegant. It is necessary.

The claims register. What it looks like

A claims register is a single table that every marketing and regulatory person can see. It has six columns.

Claim. The exact wording. Not a paraphrase. The sentence as it appears on the website, in the brochure, in the deck.

Channel. Where the claim lives. Homepage hero, product page Section 3, brochure p. 4, sales deck slide 7, IFU Section 2. If the same claim appears in five places, it gets five rows. Because a change to one copy does not automatically propagate.

Evidence source. The specific document and section that substantiates the claim. CER Section 4.2. Technical file Section 6.1.3. Performance evaluation report Section 8. ISO 14971 risk file. Usability validation report. If there is no evidence source, the claim is red and cannot ship.

Reviewer. The named person. Usually the PRRC under Article 15. Who has signed off on the claim. (Regulation (EU) 2017/745, Article 15.) Sign-off is dated and logged.

Status. Green, yellow, or red. Yellow claims get a follow-up action and a deadline. Red claims are blocked until resolved.

Last verified date. When the claim was last checked against the current version of the file. A claim that passed six months ago may no longer be supportable if the CER or the intended purpose has been updated since.

The register sits in the QMS. It is reviewed quarterly and on every material change to the product, the CER, the IFU, or the intended purpose. It is the single artefact a notified body auditor can ask for to understand how claims compliance is being managed, and the existence of a real register. As opposed to "we review stuff as it comes up". Is itself a signal of a mature QMS.

How the register gets populated

The honest answer is that the first pass is a crawl. Someone. Usually the founder, sometimes an outside regulatory consultant. Sits down with the website open in one browser tab and the technical file open in another, and works through every page, extracting every claim into the register. Homepage. About page. Product pages. Blog. Press releases. Customer stories. Case studies. Every tab that says anything about the device.

This is slow the first time. A typical startup website produces between 50 and 200 distinct claims in the first pass. The second time. When the register exists and only new or changed claims need to be added. It is a 30-minute job per review cycle.

After the website comes everything else. Brochures. Trade-show materials. Pitch deck. Sales deck. Email templates. Onboarding content. Training materials. Demo videos. The same crawl applies. And then the ongoing work: every new piece of public content gets its claims extracted into the register before it is published, not after.

Intended purpose is the anchor

If a claim is not inside the intended purpose, the answer is never "let's just phrase it more carefully." The answer is either to cut it or to change the intended purpose. And changing the intended purpose means updating the technical documentation, the clinical evaluation, and, depending on the change, the conformity assessment itself. This is the hard part to internalise. Claims management is downstream of the intended purpose, not upstream. Marketing does not get to decide what the device is for. The technical file decides. Marketing decides how to phrase what the file already says in language the user will understand. The relationship between intended purpose and intended use is the deepest anchor for everything downstream.

For a longer treatment of the channels on which Article 7 is enforced. From LinkedIn posts to conference slides. See the companion post on promotional material under Article 7. For the broader misleading-claims prohibition and how competent authorities act on it, see misleading claims under MDR.

The Subtract to Ship angle

Most startups try to manage claims reactively. Marketing writes copy. Regulatory reviews it. Back and forth, week after week, claim by claim. The system creates permanent friction between the two functions and still produces mistakes because the reviews are serial and memory-dependent.

The subtraction move is to build the register once and let it do the work. The register is the single source of truth for what can be said. Marketing pulls from it when writing new copy. Not as a constraint, as a palette. Regulatory maintains it. New claims are added when the evidence exists to support them, not when marketing wants to use them. The meetings stop because the arguments have already been settled in the register.

The register is not a creative constraint. It is a creative floor. Marketing can still decide which green claims to use, which ones to emphasise, how to structure the page, what visuals to pair with the copy, what tone to take. What marketing stops doing is inventing claims at the point of writing. That one change. Claims are picked, not invented. Eliminates most Article 7 risk at the source.

Reality Check. Where do you stand?

  1. Do you have a single document listing every public claim about your device, with its channel, its evidence source, its reviewer, and its last verification date?
  2. If a Notified Body auditor asked you to show the evidence for the first three sentences on your homepage, could you do it in under five minutes?
  3. Has the wording "clinically proven" ever appeared in your marketing? If yes, does the clinical evaluation report substantiate that exact claim for the population and conditions it implies?
  4. When the intended purpose or the CER is updated, who is responsible for re-checking every public claim against the new version?
  5. Are your comparative claims against other devices backed by head-to-head evidence that matches the specific wording of the comparison?
  6. Has anyone audited the yellow claims. Vague performance words, social-proof phrases, undefined benefit language. On your website for Article 7 exposure?
  7. Are new public claims added to the register before they are published, or only after a problem is flagged?

Frequently Asked Questions

Can I say "clinically proven" on my website? Only if the clinical evaluation report substantiates a specific clinical claim with evidence that matches the wording you use. "Clinically proven" implies demonstrated clinical benefit in the Article 61 sense. If the CER does not demonstrate the specific benefit the sentence asserts, the claim is misleading under Article 7 regardless of how accurate it feels in ordinary language.

What is the difference between a claim and a marketing headline? There is none in the regulatory sense. Article 7 treats any statement that could shape a user's or patient's perception of the device's intended purpose, safety, or performance as a claim. Whether it is a headline, a bullet point, a body-copy sentence, or an image caption. The format does not change the classification.

Who should own the claims register inside a startup? The PRRC under Article 15 is the natural owner because claims compliance is part of regulatory compliance. In very small startups, this may be the same person as the founder or the regulatory lead. What matters is that ownership is named, documented, and empowered to block non-compliant claims from shipping.

How do I handle customer testimonials and case studies? A testimonial becomes a manufacturer claim the moment the manufacturer publishes or approves it. If the customer attributes a benefit that is not in the intended purpose or not substantiated by the CER, publishing it makes that benefit a claim under Article 7. Testimonials go through the claims register like any other claim.

What about forward-looking claims in investor decks? Investor decks containing roadmap claims. Features not yet in the intended purpose, studies not yet completed. Are promotional material the moment they circulate beyond a narrow protected audience. Screenshots reach trade press and LinkedIn. The safer approach is to mark forward-looking content explicitly as "future product direction, not currently CE-marked" and to keep it out of any channel that could be seen by a user or patient.

Does the claims register need to be in the QMS formally? Yes. Claims management is a process the QMS covers because it is downstream of the intended purpose and the clinical evaluation, both of which are QMS outputs. A claims register that lives in a marketing spreadsheet outside the QMS is not traceable in an audit. Bringing it into the QMS formalises the review cadence, the sign-off authority, and the record-keeping.

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 15 (Person Responsible for Regulatory Compliance), Article 61 (clinical evaluation). Official Journal L 117, 5.5.2017.

This post is part of the Classification & Conformity Assessment cluster in the Subtract to Ship: MDR blog. Authored by Felix Lenhard and Tibor Zechmeister. Claims management is where marketing instinct meets regulatory text, and the startups that survive that collision are the ones that built a claims register before they needed it.