Under MDR Article 7, every piece of promotional material for a medical device. Website copy, brochures, trade-show banners, demo videos, LinkedIn posts, sales decks. Must stay inside the intended purpose for which the conformity assessment was carried out, and must not use any text, name, trademark, picture, or figurative sign that could mislead the user or patient about the device's intended purpose, safety, or performance. Promotional material is not a free creative surface. It is a regulated output of the technical file, and anything it says that the technical documentation does not support is a nonconformity in its own right.

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

TL;DR

  • Article 7 of Regulation (EU) 2017/745 prohibits misleading promotional material across all channels. Labelling, IFU, advertising, and any other communication visible to users or patients.
  • Promotional material is bound by the intended purpose defined under Article 2(12), which explicitly includes promotional and sales materials as an input to the intended purpose itself.
  • Four things are forbidden: attributing functions the device does not have, creating a false impression about treatment or diagnosis, omitting likely risks, and suggesting uses outside the conformity-assessed intended purpose.
  • Comparative claims against competitor devices are allowed only when they can be substantiated with objective, verifiable data. Otherwise they are misleading by default.
  • Social media posts, pitch decks, and conference slides count as promotional material the moment they reach a user or patient audience. Founders routinely forget this and the audit finds it.

Why Article 7 is where startups first meet enforcement

The first time most startups encounter Article 7 is during a Notified Body audit, when the auditor opens a browser, types the company name, and starts reading the website. Everything up to that moment has been internal. The technical file, the QMS procedures, the clinical evaluation report, the risk management file. Article 7 is the first requirement where the auditor leaves the binder and checks what the company is actually telling the world.

It is also the cheapest obligation to get wrong. A single LinkedIn post drafted by someone who has not read the intended purpose can step outside the certified scope in one sentence. A brochure printed for a trade show can carry a claim that the clinical evaluation never substantiated. A demo video voice-over can describe a function the IFU does not list. Each of these, individually, is defensible-looking marketing. Cumulatively, they are the pattern that produces nonconformities raised against the promotional material rather than against the device.

The useful reframe: promotional material is not a communications problem. It is a regulatory output. Every sentence on the website, every line in a brochure, every frame in a demo video is a claim about a regulated product, and every claim has to trace to something in the technical file. When promotional material is treated as a separate creative domain. Owned by marketing, written by copywriters, signed off by the CEO. The gap with the technical documentation widens until the audit exposes it.

The scope of Article 7

MDR Article 7 applies to the labelling, the instructions for use, the making available, the putting into service, and the advertising of devices. (Regulation (EU) 2017/745, Article 7.) That list covers nearly every surface where a device communicates with the outside world. The word "advertising" in Article 7 is not narrowly construed. In practice it covers any communication that could shape a user's or patient's perception of the device. From a banner at a medical congress to a tweet from the company account.

Article 7 prohibits four specific things in all of these channels. First, text, names, trademarks, pictures, or figurative signs that may mislead the user or patient about the device's intended purpose, clinical benefits, safety, or performance. Second, attributing functions and properties to the device which it does not have. Third, creating a false impression regarding treatment or diagnosis, functions, or properties that 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. Fourth, 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 these four prohibitions is independently enforceable. A piece of promotional material can stay inside the intended purpose in its words and still fail Article 7 by using an image that implies a function the device does not have, or by omitting a risk that the IFU lists.

What counts as promotional material

Founders routinely underestimate how broad this category is. The default mental model is "the website and the brochures." The regulatory reality is larger.

Promotional material includes the product pages of the company website, marketing landing pages, SEO pages, blog posts written by the company, email newsletters, printed brochures, leave-behinds, trade-show booth graphics, roll-up banners, conference slides when the slides are about the product, demo videos whether on the website or on YouTube, explainer animations, product photography used publicly, press releases, company statements quoted in trade press, LinkedIn posts from the company page, LinkedIn posts from employees speaking about the product in their professional capacity, sales decks sent to prospective customers, pitch decks when they reach public or semi-public audiences, onboarding emails to new customers that describe the device, and the copy on any reseller or distributor site that the manufacturer has approved or supplied.

Anything the user or patient can see that shapes their perception of the device is promotional material in the Article 7 sense. The format does not matter. The distribution channel does not matter. The question is whether it could form an impression in the mind of a user or patient about the device's intended purpose, safety, or performance. If yes, Article 7 applies.

The intended purpose subset rule

Article 2(12) of the MDR 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 sentence slowly. The definition of intended purpose explicitly includes promotional and sales materials as one of the inputs. Promotional material is not a downstream reflection of the intended purpose. It is one of the sources the regulator treats as constitutive of the intended purpose. If the website says the device does X, the regulator can and will treat X as part of what the manufacturer claims the device is for. The question then is whether the technical documentation and the clinical evaluation support X.

This creates a one-way rule that makes claims compliance tractable. Promotional material must be a strict subset of the intended purpose declared and substantiated in the technical documentation. Never a superset. The IFU, the labelling, and the technical file describe the complete certified scope. Promotional material can describe any part of that scope, in any language the user can understand, with any level of emphasis marketing chooses. What it cannot do is add a single claim that is not already in the file. The moment it does, Article 2(12) pulls the new claim into the legal intended purpose. And the technical file does not support it, so the conformity assessment is no longer covering what the manufacturer is actually placing on the market.

The four prohibitions in practice

The four prohibitions in Article 7 translate into concrete failure patterns on the ground.

Attributing functions the device does not have. A physiological monitoring device is certified to measure heart rate and SpO2. The website says "measures stress levels." Stress measurement is not a certified function. The website has attributed a function the device does not have.

Creating a false impression about treatment or diagnosis. A wellness app is certified as a lifestyle tool. A marketing video shows a clinician recommending it to a patient as part of a treatment plan. The video creates a false impression that the app is a medical device delivering treatment. Article 7 violation.

Omitting a likely risk. The IFU lists a contraindication for patients with active implantable cardiac devices. The website product page does not mention it. A prospective user with an ICD reads the website, forms the impression the device is safe for them, and uses it. The omission is the Article 7 failure, independent of whether any harm occurred.

Suggesting uses outside the conformity assessment. A device is certified for use by trained clinicians in a clinical setting. A brochure aimed at consumer health spas suggests the device can be used by non-clinical staff. The brochure has suggested a use outside the intended purpose for which the conformity assessment was carried out. Even if no spa ever buys the device, the brochure is non-compliant.

Each of these failures has the same shape: a gap between what the technical file covers and what the promotional material claims. The fix for each is the same: reduce the promotional material to what the file supports, or. If the claim is truly important to the commercial strategy. Go back and extend the intended purpose, the clinical evaluation, and the technical documentation to cover it, then update the conformity assessment. There is no middle path.

Comparative claims against other devices

Comparative claims. "our device is more accurate than Competitor X," "faster than the leading alternative," "the only device that does Y". Are a high-risk subcategory. They are not forbidden by default, but they are bound by the same misleading-claim prohibition as any other promotional statement.

The rule is substantiation. A comparative claim is acceptable under Article 7 only if it can be backed by objective, verifiable evidence that supports the specific comparison. "More accurate than Competitor X" needs head-to-head data, published or internal, with defined endpoints and matching conditions. "The only device that does Y" needs a defensible definition of Y and evidence that no other currently marketed device does Y. "Faster than the leading alternative" needs a definition of "leading," a definition of "faster," and data for both.

Without that evidence, the comparative claim is misleading by construction. It attributes a relative property to the device that cannot be verified, which is exactly what Article 7 prohibits. Competitors can and do file complaints with competent authorities over unsubstantiated comparative advertising, and the investigation lands on the manufacturer that made the claim, not the one that complained.

The practical rule for startups: avoid comparative claims unless you have the data and have reviewed the data against the specific wording of the claim. The rhetorical gain from "better than" is rarely worth the regulatory exposure.

Social media, pitch decks, and the quiet channels

The promotional material audit findings that surprise founders most often come from channels the team never thought of as regulated. Three recur.

LinkedIn posts. An employee posts about a customer outcome. The outcome is real. The post attributes it to a device function. If the function is not in the intended purpose, the post is a misleading claim under Article 7, and the fact that it came from a personal account rather than the company page does not save it when the employee is speaking in their professional capacity.

Pitch decks. Investor decks routinely contain forward-looking claims. "the product does X" where X is roadmap rather than certified function. When the pitch deck circulates beyond a narrow NDA-protected audience, it becomes advertising in the Article 7 sense. Screenshots from pitch decks show up on trade blogs, in LinkedIn posts by attendees, and in competitor research, and the manufacturer is still the source.

Conference slides. A founder gives a conference talk. The slides describe the product in language the IFU does not use. The slides are shared publicly after the talk, either by the organiser or by attendees. The talk is now promotional material, and every claim on every slide is subject to Article 7.

The common thread in all three: founders assume these channels are different from "real" advertising, and they are not. The regulator does not care about the distinction.

Common mistakes startups make

A short list, each one a mistake Tibor has seen more than once.

  • Writing promotional copy before the intended purpose is finalised, then treating the promotional language as fixed and asking the regulatory team to "make the file match."
  • Letting a marketing agency or external copywriter produce material without giving them the intended purpose statement and the IFU as source documents.
  • Assuming personal LinkedIn posts by employees are outside the scope of Article 7.
  • Using stock images of clinicians or patients that imply an intended use context different from the one certified.
  • Running landing-page A/B tests where the winning headline happens to overreach the intended purpose and nobody notices.
  • Publishing customer testimonials verbatim when the testimonial attributes outcomes the clinical evaluation does not substantiate.
  • Treating press releases as PR rather than regulatory documents and skipping the claims review step before release.
  • Allowing distributors and resellers to produce their own material under the manufacturer's brand without review.
  • Forgetting that older promotional material on the website. The blog post from 2022, the legacy product page. Is still live and still subject to Article 7 today.

Each of these is preventable with a single structural move: every public-facing claim passes through a reviewer who has the intended purpose and the IFU open at the moment of review.

The Subtract to Ship angle

The Subtract to Ship approach to promotional material inverts the default startup sequence. The default is: marketing writes the copy first, regulatory reviews it afterwards, and the back-and-forth wastes weeks while the copy is either watered down or forced through. The subtraction move is the opposite. The intended purpose and the IFU come first. The promotional material is derived from them. Marketing is not deciding what the product does. The technical file is. Marketing is deciding how to say what the technical file already documents in language that the intended user will understand and act on.

This is not a constraint on creativity. It is a constraint on invention. Marketing can still choose tone, structure, emphasis, imagery, layout, sequencing, and the voice of the copy. What it cannot do is invent new functions, new indications, new use contexts, or new claims of performance. Inside that boundary there is plenty of room for good marketing. Outside it there is only regulatory risk.

The practical implementation is a single reviewer. Usually the PRRC under Article 15 or a delegated regulatory lead. Who signs off on every piece of promotional material before it goes public. The reviewer has the intended purpose, the IFU, the clinical evaluation, and the risk file open at the moment of review. They ask four questions: is this claim in the intended purpose, is it substantiated in the clinical evaluation, does it match the IFU, and would it defend itself in front of an auditor reading it next to the technical file. Anything that cannot answer all four with yes is cut or rewritten. The cost is small. An hour a week for most startups. And it prevents the cascade of nonconformities that late-stage audit discoveries produce.

Reality Check. Where do you stand?

  1. Does one named person at your company sign off on every piece of promotional material before it goes public, with the intended purpose and the IFU open in front of them?
  2. For every claim currently on your website, can you point to the section of the technical documentation that substantiates it?
  3. When did you last audit your LinkedIn feed, your employees' professional posts, your press releases, and your sales decks for claims that step outside the intended purpose?
  4. If you make comparative claims against other devices, do you have head-to-head evidence for every specific comparison. And has that evidence been reviewed against the exact wording of the claim?
  5. Do the images on your product pages imply a use context (clinical setting, user type, patient group) that matches the certified intended purpose?
  6. Do the risks in your website copy match the contraindications, warnings, and precautions in your IFU, or is the IFU the only place where they appear?
  7. Are your legacy blog posts and archived press releases still on the site, and have you checked them against the current intended purpose?

Frequently Asked Questions

Is a LinkedIn post from my personal account promotional material under Article 7? If you are speaking in your professional capacity as a representative of the manufacturer, and the post describes the device in a way that could influence a user or patient, yes. The channel does not change the regulatory classification. What matters is whether the content could shape perception of the device's intended purpose, safety, or performance.

Can I make comparative claims against a competitor device? Only if you can substantiate the specific comparison with objective, verifiable evidence. A general "better than" claim without data is misleading by default. A specific comparison on a defined endpoint, backed by head-to-head data and accurate wording, is acceptable. Most startup comparative claims fail because the wording is broader than the data supports.

What is the risk if the website says more than the intended purpose? During a Notified Body audit, the auditor can and will read the website. A mismatch produces a nonconformity against the promotional material, and the resolution is either to reduce the website or to extend the conformity assessment. And extending the assessment is almost always slower and more expensive. Competent authorities can also act independently on misleading advertising, up to market withdrawal.

Do employee testimonials and customer quotes count as promotional material? Yes. If the manufacturer publishes or approves a testimonial that attributes outcomes or properties to the device, the testimonial becomes a claim by the manufacturer. Publishing a customer quote that attributes a benefit outside the intended purpose makes that benefit a claim under Article 7.

Who is responsible for promotional material compliance inside a startup? The manufacturer is legally responsible. In practice, the Person Responsible for Regulatory Compliance under Article 15 is the natural reviewer, but the ultimate accountability sits with the manufacturer as a whole. Whoever signs off on public claims needs both access to the technical documentation and the authority to block or rewrite material that falls outside the certified scope.

Does Article 7 apply to material we produced before CE marking? Article 7 applies to devices placed on the market. Material published before CE marking that is still live after CE marking is subject to Article 7 from the moment the device is placed on the market. Old blog posts and legacy pages do not become exempt because they were written earlier. If they are visible today, they are subject to today's obligations.

Sources

  1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, Article 7 (claims, promotional materials), Article 2(12) (intended purpose). Official Journal L 117, 5.5.2017.

This post is part of the Technical Documentation & Labeling cluster in the Subtract to Ship: MDR blog. Authored by Felix Lenhard and Tibor Zechmeister. Promotional material is the channel where many startups first discover that the regulation reaches beyond the binder. And the fix, as always, is to derive the material from the technical file rather than the other way around.