Your comfort product is not a medical device: how health claims creep into ad copy, and the law that decides

The line in the ad said the product helps with reflux and snoring. Another one said it was ideal after an operation or after giving birth. A keyword group was bidding on searches from people looking for a device to help them get out of bed.

The product is a piece of adjustable bedroom furniture. It is not a medical device, it has never been assessed as one, and the company that makes it has never claimed it was. Nobody sat down and decided to advertise it as a treatment. The claims arrived one at a time, over about two years, each one slightly bolder than the last, written by whoever was next to touch the account.

Claims accumulate because nobody owns them

This is the part I would stress to anyone running paid media on a product that sits anywhere near health. Ad copy is not written once. It is written continuously, by agencies, by freelancers, by a responsive search ad that recombines fifteen headlines into whatever converts, and increasingly by automated asset suggestions that the platform generates for you. Every one of those authors is optimising for click-through. None of them is reading the regulations.

So the drift is one-directional. "Raises the upper body" becomes "better sleeping position" becomes "helps with reflux" becomes "ideal after an operation". Each step is a small, defensible-sounding improvement on the last. The end state is an advertisement for a medical indication, attached to a product that has no medical approval behind it, and nobody in the chain ever made that decision.

When I audited a home and living brand's accounts across its German-speaking markets this week, I rewrote ten search ads, paused five keywords, and changed two site-wide callouts. Most of it was straightforward accuracy work — a founding year that was nine years out, "Made in Germany" on a product made elsewhere in Europe, a customer count that had been repeated so often nobody knew where it came from. But the health lines were a different category of problem, and they were the ones I pulled first.

Where the legal line actually sits

Two separate regimes decide this in Europe, and marketing teams routinely confuse them.

The first is what a medical device is. Under the EU Medical Device Regulation, that is determined by the intended purpose the manufacturer assigns to the product — including through its advertising. This is the trap. A product is not a medical device because of what it is made of; it can become one because of what you say it does. Claim a diagnostic, preventive, monitoring or treatment purpose for a disease, and you have potentially declared your furniture a regulated device, with all the conformity assessment that implies. You cannot get the marketing benefit of a medical claim while staying outside the regulatory perimeter. The claim is what puts you inside it.

The second is what you may say in an advertisement at all. In Germany the Heilmittelwerbegesetz prohibits misleading advertising in the health field, specifically including attributing an effect a product does not have. Section 12 and its annex go further and list conditions that may not be advertised to the public at all. These are not obscure provisions. They are routinely enforced through competitor warning letters, which is how most companies find out about them — by receiving one.

And then there is the platform layer, which is where it bites first in practice. Google's healthcare and medicines policy restricts health-related advertising by country and advertiser type, and disapprovals here are mechanical and unsympathetic. You do not get a conversation. You get an ad that stops serving.

A claim is not a sentence in an ad. It is a position you have taken, and somebody else decides what it means.

What a claim register looks like

The fix is not a lawyer on retainer. It is one document that almost no mid-sized company has: a list of the things you are allowed to say about each product, with a source next to each one.

For this brand it took an afternoon. Pull the manufacturer's own product pages. Write down the specification claims that are verifiably true — the angle of adjustment, the weight capacity, the dimensions, where it is manufactured, the warranty, the return period per market. Write down the founding year and the customer count from the company's own records. Then, separately, write down the claims that are not approved: any disease named, any clinical outcome, any "helps with", any "ideal after".

That second list is the valuable one, because it is what you hand to an agency, paste into the brief, and check ad copy against. It also gives you something to search for. I ran the not-approved list as a literal text scan across the ad accounts, the product templates and the live pages, and it found hits in places nobody would have audited by hand — a product page template that renders on every product in a market, a callout extension shared across twelve campaigns including paused ones in two other countries.

Paused campaigns matter more than they look. The copy in them is frozen at whatever it said the day someone switched it off, and it starts serving again the moment anyone turns it back on, usually in a hurry, usually before a seasonal peak. Several of the worst lines I found this week were in campaigns that were not running. They were a loaded gun pointed at the next person under time pressure.

The honest version usually performs fine

Here is what I did not expect the first time I did this exercise, years ago. Replacing a medical claim with a specific physical fact rarely hurts performance, and often helps. "Helps with reflux" is a promise a stranger has no reason to believe. "Raises the upper body up to 59 degrees, under your existing mattress" is a thing they can picture, measure against their own bed, and act on.

People shopping for this kind of product already know why they are shopping. They do not need you to name their condition back at them. They need to know whether it fits.

I have written before about clinics advertising into empty appointment slots and about why invented testimonials are a liability rather than a shortcut. Same underlying issue every time: a claim that nobody can stand behind is not a marketing asset. It is a dated liability sitting in an account, waiting for the right person to read it.

Go and read your own ads as if you were a competitor's lawyer. It takes an hour, and you will find something.

Sources & further reading

External
European Commission — Medical devices: new EU regulations (MDR 2017/745)
Heilmittelwerbegesetz § 3 — Irreführende Werbung
Heilmittelwerbegesetz § 12 — Werbung für bestimmte Krankheiten
Google Ads — Healthcare and medicines policy

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