Advertising medical devices under the Medical Device Regulation (MDR) - Free initial assessment of your case

Medical Devices Regulation (MDR) provides exhaustive rules for medical devices

Medical devices and in vitro diagnostic devices no longer fall within the scope of Section 3 HWG. This is because misleading claims for these products are regulated exhaustively by EU law, namely by Article 7 of the Medical Devices Regulation (Regulation (EU) 2017/745 of 5 April 2017 on medical devices (MDR)) and Article 7 of the In Vitro Diagnostic Medical Devices Regulation (Regulation (EU) 2017/746 of 5 April 2017 on in vitro diagnostic medical devices).

Unlawful advertising for medical devices is often challenged by means of a cease-and-desist letter under competition law or an application for an interim injunction.

Definition of “medical device”

The definition of “medical device” is set out in Article 2(1) of Regulation (EU) 2017/745 on medical devices (Medical Devices Regulation – MDR): A “medical device” is an item intended by the manufacturer for use in humans, alone or in combination, for one or more of the following specific medical purposes:

• diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of diseases,
• diagnosis, monitoring, treatment or alleviation of, or compensation for, injuries or disabilities,
• investigation, replacement or alteration of the anatomy or of a physiological or pathological process or state,
• Obtaining information through in vitro examination of samples originating from the human body—including organ, blood and tissue donations

and its principal intended effect in or on the human body is not achieved by pharmacological, immunological or metabolic means, but may be assisted by such means. The following also qualify as medical devices:

• Products for preventing or promoting conception,
• Products for cleaning, disinfecting or sterilising medical devices and accessories

Essential for pharmacists and drugstore operators:

“Advertising for Health and Beauty with Legal Certainty”



The practical guide to medicines advertising law and advertising for food supplements, health claims, foods for special medical purposes, medical devices and cosmetics – available from bookshops or Amazon

Advertising for health-related products is subject to particularly extensive regulation. Case law imposes strict requirements on health-related claims. Advertising for medicines and other remedies, medical devices, food supplements, foods for special medical purposes and cosmetics is also restricted by specific laws and regulations. The risk of cease-and-desist letters and legal disputes is particularly high for these products. This book sets out the current law through several hundred examples from case law.

Contents:

• Selection of terms, texts and media
• Advertising with Trademarks
• General principles of competition law, misleading and comparative advertising, advertising with prices and discounts
• Search engine optimisation and advertising, social media and influencer marketing
• General requirements for health-related advertising
• Prohibitions and restrictions under medicines advertising law
• Advertising for medicinal products, pharmaceutical price controls, and advertising discounts and benefits
• Advertising medical devices
• Advertising food supplements, especially HEALTH CLAIMS
• Advertising for foods for special medical purposes
• Advertising for cosmetic products

Back to table of contents

1st edition, November 2024, 408 pages, XchangeIP Verlag, available from bookshops or Amazon

ISBN 978-3-00-079406-3

Advertising a medical device? A medical device must have an intended medical purpose

An object designed by its manufacturer for use on humans to examine a physiological process falls within the definition of a “medical device” only if it is intended for a medical purpose (ECJ v. 22.11.2012 – C-219/11 (Brain Products GmbH/BioSemi VOF). A product is therefore not intended for medical purposes if its labelling, instructions for use and advertising clearly rule out use for medical purposes.

Example:

A company offered a system for measuring and recording human brainwaves. The product carried the following notice:

"Notice: B. products are intended for use only in research applications. Our products are not marketed as medical devices within the meaning of EU Directive 93/42/EEC. Our products have not been developed or intended for use in diagnosing or treating diseases.“

That was sufficient to rule out medical purposes and thus classification as a medical device (Federal Court of Justice, judgment of 18 April 2013 – I ZR 53/09 – Measuring device II).

Distinguishing a medical device from a medicinal product

Unlike medicines, which have a pharmacological effect, medical devices have a physical effect. This physical effect can be produced not only by an object, but also by a substance (“substance-based medical device”).

Examples of medical devices

A substance-based medical device is, for example, a

• Bowel-cleansing powder that works by osmotic and physical means (Federal Court of Justice, judgment of 10 Dec 2009 - I ZR 189/07 - Distinguishing between medicinal products and medical devices (Macrogol)).

A medical device is also

• a vascular scaffold to improve blood flow (stent). This applies even if an active substance is released to prevent excessive tissue growth and the scaffold is bioresorbable, meaning it dissolves in the body after some time (BGH, judgment of 1.2.2018 – I ZR 82/17 – Gefäßgerüst).

Further examples of medical devices

The courts have classified the following as medical devices:

• Condoms (see LG Düsseldorf, judgment of 7 March 2018 – 12 O 76/17 – CE marking of medical devices; see now also expressly Article 2(1), third subparagraph, first indent of the Medical Devices Regulation)
• Glasses (Federal Court of Justice, judgment of 6 November 2014 – I ZR 26/13 – Free Second Pair of Glasses)
• Incontinence briefs (OLG Hamburg, judgment of 20 June 2019 – 3 U 137/18 – Incontinence briefs)
• “Health mats” (KG, judgment of 21 December 2018 – 5 U 138/17 – Unlawful advertising using health claims)
• Healing clay (Higher Regional Court of Frankfurt am Main, judgment of 2 December 2021 – 6 U 121/20 – Healing clay for detoxification)
• Cough syrups and cough lozenges (OLG Karlsruhe, judgment of 22 June 2022 – 6 U 259/21 – productive cough)
• Devices for stimulating muscles with electrical or magnetic impulses (LG Düsseldorf, judgment of 21 June 2023 – 12 O 115/22 – THE BODY OF YOUR DREAMS WITHOUT ANY EXERCISE!)

The following are not medical devices

• FFP2 face masks (Brandenburg Higher Regional Court, order of 18 March 2021 – 6 W 15/21; LG Hamburg, judgment of 9 February 2023 – 312 O 42/21 - Prämienwelt)
• Cloth face masks (Higher Regional Court of Hamm, order of 15 December 2020 – I-4 W 116/20 – Cloth Face Mask)

Absolute advertising bans on certain medical devices when directed at the general (non-professional) public

Under Section 12(1) No. 2 HWG, advertising certain medical devices to people outside professional circles is generally prohibited. These are medical devices relating to the diagnosis, prevention, elimination or alleviation of the diseases and conditions in humans listed under Nos. 1, 3 and 4 of the Annex to Section 12 HWG. Advertising for in vitro diagnostics under Annex 3 to Section 3(4) of the Medical Devices Dispensing Regulation is exempt.

Misleading advertising for medical devices and in vitro diagnostics

Article 7 of the Medical Devices Regulation and Article 7 of the In Vitro Diagnostic Medical Devices Regulation govern misleading advertising for these products. The provisions are identical in content. As under the law governing the advertising of medicinal products, Article 7 of the Medical Devices Regulation and Article 7 of the In Vitro Diagnostic Medical Devices Regulation prohibit only misleading product advertising. Misleading advertising about a company is governed by the general rules on misleading commercial practices under competition law.

Misleading efficacy claims

Under Article 7(a) of the Medical Devices Regulation and Article 7(a) of the In Vitro Diagnostic Medical Devices Regulation, it is prohibited to mislead as to the intended purpose (see Article 2(12) of the Medical Devices Regulation), safety or performance by attributing functions and properties to a product that it does not have. However, when applying Article 7(a) of the Medical Devices Regulation, the criteria established by case law on § 3 HWG may be relied upon (Higher Regional Court of Frankfurt am Main, 2.12.2021 – 6 U 121/20 – Healing clay for detoxification; Higher Regional Court of Hamm, 21.4.2022 – 4 U 39/22 – Prohibition on misleading health-related advertising for a medical device – wound dressings). The principles governing health-related advertising also apply to medical devices, in particular the “strictness principle” (Higher Regional Court of Frankfurt am Main, 2.12.2021 – 6 U 121/20 – Healing clay for detoxification; Higher Regional Court of Hamm, 21.4.2022 – 4 U 39/22 – Prohibition on misleading health-related advertising for a medical device – wound dressings).

Medical devices may be offered only with CE marking in accordance with Article 20 of the Medical Devices Regulation

A medical device may only be placed on the market if it bears a CE marking in accordance with Article 20 of the Medical Devices Regulation (Regulation (EU) 2017/745) and an EU declaration of conformity has been drawn up. The CE marking may only be affixed if the product meets the applicable safety and performance requirements.

The CE marking must be affixed visibly, legibly and permanently to the product or its sterile packaging (Article 20(3) of the Medical Devices Regulation). If the nature of the product makes it impossible or impractical to affix the CE marking to the product or its sterile packaging, the CE marking must be placed on the packaging (unit packaging, sales packaging or commercial packaging). The CE marking must also appear in every instruction for use and on every commercial package.

CE marking does not indicate the efficacy of a medical device

Who must carry out the conformity assessment procedure under Article 52 of the Medical Devices Regulation depends on the product’s risk class. Only for the lowest risk class, Class I, may the manufacturer carry out the conformity assessment procedure itself. For all other medical devices, the conformity assessment procedure is carried out by a “Notified Body” (a private medical device certification body). The Notified Body does not itself assess the efficacy of the medical device. It issues the certificate of conformity solely on the basis of the documents provided by the manufacturer (see Article 45 of the Medical Devices Regulation). CE certification therefore does not rule out judicial review of an efficacy claim (see OLG Karlsruhe, judgment of 22 June 2022 – 6 U 259/21 – Produktiver Husten).

Further grounds for finding medical devices misleading

Under Article 7 of the Medical Devices Regulation and Article 7 of the In Vitro Diagnostic Medical Devices Regulation, it is also prohibited to mislead about the intended purpose (see Article 2(12) of the Medical Devices Regulation or the In Vitro Diagnostic Medical Devices Regulation), safety or performance by

• creates a false impression among patients or users about the treatments or diagnoses, or the product’s functions or properties (Article 7(b) of the Medical Devices Regulation or the In Vitro Diagnostic Medical Devices Regulation),
• foreseeable risks of use are omitted (Article 7(c) of the Medical Devices Regulation or the In Vitro Diagnostic Medical Devices Regulation),
• other uses for the product are recommended than those for which the conformity assessment was carried out in accordance with the intended purpose (Article 7(d) of the Medical Devices Regulation or the In Vitro Diagnostic Medical Devices Regulation). 

Special requirements for environmental claims under the EmpCo Directive

From 27 Sep 2026, advertising using environmental claims will be subject to the strict rules of the EmpCo Directive. Such environmental claims include, for example

“environmentally friendly”, “environmentally compatible”, “biodegradable” or “bio-based”. Warning letters may be issued over environmental claims and sustainability labels.

Author: Thomas Seifried,
Lawyer specialising in medicinal product advertising law and
Specialist lawyer for intellectual property law