Caution with the Designation of COVID-19 Masks
In the course of the COVID-19 pandemic, all 16 German federal states have now introduced compulsory masks. In most of the federal states this duty to wear masks is to apply to shops and public transport. It is sufficient in all federal states to wear ordinary fabric masks (hereafter "mouth-nose coverings"; see also e.g. for Bavaria the Regulation amending the Second Bavarian Infection Control Regulation of 21 April 2020). For this reason, there is at present a very high demand for such mouth-nose coverings which more and more companies and individuals are striving to meet. The manufacturers of such mouth-nose coverings should pay attention to the correct terminology when naming and describing them.
1. No guaranteed protective effect
Mouth-nose coverings are masks which are sewn (partly in own production on the basis of instructions provided on the Internet) from commercially available materials. Such mouth-nose coverings are intended in particular to slow down the speed of the wearer's breath and droplet emission (e.g. when coughing). This is intended to reduce the risk of infection of the wearer's immediate environment. In addition, however, such masks do not guarantee protection for the wearer's surroundings, and certainly not for the wearer himself.
Compared to a medical mouth-nose protection that is to be classified as a medical device (e.g. surgical mask), the mouth-nose covering therefore provides (if at all) considerably less protection for others. In addition, a mouth-nose covering does not provide self-protection and must therefore be distinguished from so-called "personal protective equipment" (e.g. filtering half masks). There are also differences in legal terms, as simple mouth-nose coverings do not meet the relevant requirements for medical devices and personal protective equipment or have undergone the statutory verification procedures.
2. Designation and description of mouth-nose coverings must not suggest a protective effect
Manufacturers of mouth-nose coverings must therefore take care when designating and describing them, to avoid giving consumers the impression that they are medical devices or personal protective equipment. In particular, the designation and description must not suggest that the masks have a protective effect. This is also pointed out by the Federal Institute for Drugs and Medical Devices ("BfArM") in its Recommendation of 31 March 2020. It is therefore problematic if mouth-nose coverings are, for instance, referred to as "respiratory protection mask" or "mouth protection". This way, consumers are made believe that there is a (tested) protection which is just not available for mouth and nose coverings.
3. Legal consequence: Violation of the prohibition to mislead
If mouth-nose coverings are placed on the market under a name and/or a description which suggests a protective effect to consumers, this constitutes a violation of the prohibition of misleading information according to section 4 (2) German Medical Devices Act (MPG). If the mouth-nose coverings are also advertised in this way, this advertising also violates the prohibition of misleading advertising as laid down in section 3 German Act on the Advertising of Therapeutic Products (HWG) and section 5 German Unfair Competition Act (UWG). An intentional violation of the two aforementioned prohibitions of the MPG and the HWG even constitutes a criminal offence.
4. How can manufacturers avoid violations?
Manufacturers of mouth-nose coverings should therefore make sure that the designation and description do not indicate a protective function. Accordingly, the terms "respiratory protection" or "protective mask" should be avoided. Apart from the term "mouth-nose coverings" used here, a designation as "mouth cover", "mouth-nose mask", " auxiliary mask" or "community mask", for instance, is also not objectionable. To rule out any risk of misleading consumers, the manufacturer should also expressly point out in the product description that it is neither a medical device nor personal protective equipment.
Dr David Moll