Start with the audience and the complete message

The new rules amend the Unfair Commercial Practices Directive and the Consumer Rights Directive. They are particularly relevant where dressings, contact lenses, thermometers, blood-pressure monitors or other devices are promoted to individuals acting outside their trade or profession. Medical-device status does not create an exemption from consumer protection law.

This does not mean that every statement used only in a business-to-business transaction is automatically governed by the same consumer rules. Manufacturers should map the audience, jurisdiction, channel and overall impression of each claim. The official source is Directive (EU) 2024/825.

A claim is not limited to written copy. A trade name, sustainability badge, colour, image or combination of these elements may communicate an express or implied environmental benefit. A green pack carrying a leaf and the name “EcoDevice” can therefore require substantiation even without a sentence stating that the device is environmentally preferable.

Four medical-device scenarios to review

“Natural” or “biodegradable” dressings

A claim may appear to cover the complete device even when the evidence concerns only the backing material or outer packaging. “Biodegradable” can also imply breakdown in ordinary conditions, while a test may cover industrial composting under controlled conditions. Define the exact component, test conditions, time and disposal route.

Recycled content in syringe packaging

Do not transfer an attribute of the carton or secondary plastic tray to the sterile device. A specific recycled-content percentage can be useful only when the denominator, component and calculation method are clear and supported by current records.

“Climate neutral” contact lenses based on credits

The Directive adds a blacklist item for claiming, based on greenhouse-gas offsetting, that a product has a neutral, reduced or positive environmental impact in terms of greenhouse-gas emissions. Buying credits does not make that product claim permissible after the application date.

A manufacturer-created “Sustainable Choice” badge

A sustainability label may be displayed only where it is based on a qualifying certification scheme or established by public authorities. The rule is not limited to public ecolabels: a private scheme can qualify, but it must meet the Directive’s conditions, including third-party verification and transparent requirements.

Separate blacklist items from case-by-case risk

Precision matters. The categorical offset rule concerns product claims expressed in terms of greenhouse-gas emissions. It should not be restated as an automatic ban on every compensation-based claim about any environmental issue. For example, a “plastic neutral” programme is not caught by that exact blacklist item merely because it funds plastic collection. It may still be misleading if it suggests a property of the device, omits material conditions or lacks adequate evidence.

Generic claims such as “green”, “eco-friendly”, “environmentally friendly”, “biodegradable” or “biobased” are also blacklisted where the trader cannot demonstrate recognised excellent environmental performance relevant to the claim. Adding an accessible and prominent specification on the same medium can mean that a claim is no longer generic, but the specific claim must still be accurate and non-misleading under the wider rules.

Verified data are evidence, not permission

An environmental product declaration (EPD), product carbon footprint (PCF) or life-cycle assessment (LCA) may support a defined numerical statement. None of these documents gives blanket permission to call a product “green”. The communication must stay within the documented product identity, system boundary, declared or functional unit, data period, scenarios and limitations.

Comparative claims need an additional compatibility check. Two verified values are not necessarily comparable if the underlying product-category rules, units, use patterns or end-of-life scenarios differ. The technical guide Can an EPD Substantiate a Green Claim? explains how verified life-cycle information should be read before it is converted into public-facing copy.

How this fits an EU market-entry file

For a non-EU manufacturer, environmental copy should be reviewed alongside the intended purpose, regulated performance claims, label, instructions for use and distributor materials. The legal manufacturer remains responsible for its commercial claims. An authorised representative is not a general advertising approval body, but inconsistent or unsupported public claims can expose the market-entry relationship to authority requests and document-control problems.

A practical pre-launch review should therefore identify:

• every consumer-facing environmental statement, symbol, product name and visual cue;
• whether the claim covers the device, a component, the packaging or an external programme;
• the controlled evidence, method, owner and review date for each specific claim;
• all greenhouse-gas claims that depend on offsetting;
• the operator, rules, verification route and public information behind each sustainability label;
• translations and distributor copy that may broaden the original English statement.

What to complete before 27 September 2026

Build a claims register across labels, websites, catalogues, social media, point-of-sale materials and retailer listings. Remove prohibited product-level greenhouse-gas offset claims. Replace vague wording only where a narrower statement is both commercially useful and supported by evidence. Then route each revised claim through regulatory, legal and environmental review before artwork approval.

The deadline comes from Article 4 of Directive (EU) 2024/825. National enforcement and remedies depend on the implementing law in each Member State, so manufacturers should monitor the countries in which consumer-facing devices are sold rather than treating one label review as a substitute for market-specific legal assessment.