In a decision dated December 15, 2020 (Case No. I-4 W 116/20), the 4th Civil Senate of the Higher Regional Court of Hamm had to deal with the question of whether an “everyday mask” in the form of a “textile mouth-nose covering” is a medical device and – if this were not the case – whether this would have to be clearly indicated.

Key Facts

The 4th Civil Senate of the Higher Regional Court of Hamm dealt with the classification of "everyday masks".
The applicant company from Isernhagen wanted to have the sale of "fabric masks" banned.
The Regional Court of Münster prohibited the sale of the "mouth and nose mask", but rejected the application for the "fabric mask".
The "fabric mask" was not considered a medical device within the meaning of the Medical Devices Act.
The assessment depends on the manufacturer's determination, not on retail use.
According to the manufacturer, the "everyday mask" did not serve a medical purpose and was not assigned to any particular product protection category.
It was not necessary for the distributor to clarify that the product was not a medical device in accordance with the applicable infection control regulations.

In summary proceedings, the applicant company from Isernhagen is demanding that a wholesaler from Drensteinfurt stop selling a “fabric mask” suitable for covering the mouth and nose and a “mouth and nose mask”.

The Münster Regional Court, which initially dealt with the matter, prohibited the company from Drensteinfurt from distributing the “mouth and nose mask” by order dated November 6, 2020 (Case No. 025 O 89/20). It rejected the further application with regard to the “fabric mask”. The applicant company from Isernhagen has filed an immediate appeal against this decision.

Without success!

The distribution of the mask – according to the Senate – would not be prevented by the Medical Devices Act (MPG), which is intended to regulate the circulation of medical devices and thereby ensure the safety, suitability and performance of the medical devices as well as the health and necessary protection of patients and users of the devices in particular.

This is because the “fabric mask” is not a medical device within the meaning of Section 3 No. 1 of the MPG. For the assessment of whether a product – as required for classification as a medical device – serves a medical purpose, it is the (subjective) determination of the manufacturer that is important, as it results from the information that can be taken from the labeling, the instructions for use or the advertising.

The mask itself was not provided with an indication of usability for medical purposes. Also according to its design and presentation, it could not be assumed that the mask could be used for medical purposes: The mask was printed with a drawing – in the style of a comic drawing – of an open mouth with gaps in the teeth on a green background. The packaging of the mask also does not contain any indication of usability for medical purposes.

The fact that the mask may have been displayed at retail along with medical-looking face masks was not attributable to the manufacturer or importer, nor to the wholesaler from Drensteinfurt. In the language of the currently applicable infection protection regulations for protection against new infections with the corona virus, the mask in question is no more than a so-called “everyday mask” in the form of a “textile mouth-nose covering” (cf. Section 3 (1) of the currently applicable North Rhine-Westphalian Corona Protection Ordinance).

The fact that such an “everyday mask” is considered to have a protective effect against the spread of the coronavirus in the opinion of the scientific community, the legislator responsible for the protection against infection and the relevant public does not change the fact that it does not serve any medical purpose according to the manufacturer’s specifications. Also, water and soap would not become “medical devices” because regular hand washing is generally considered and recommended by the competent authorities to have a protective effect against infection with coronavirus.

The wholesaler against whom the claim was made also did not have to make it clear that the “fabric mask” was not a “medical device” when it was distributed. In particular, it is absurd that the relevant public would classify the “everyday mask” in question as belonging to a product category that is specifically regulated by law in terms of consumer protection, protection against infection, health protection or safety.

Author: Marian Härtel

Marian Härtel ist Rechtsanwalt und Fachanwalt für IT-Recht mit einer über 25-jährigen Erfahrung als Unternehmer und Berater in den Bereichen Games, E-Sport, Blockchain, SaaS und Künstliche Intelligenz. Seine Beratungsschwerpunkte umfassen neben dem IT-Recht insbesondere das Urheberrecht, Medienrecht sowie Wettbewerbsrecht. Er betreut schwerpunktmäßig Start-ups, Agenturen und Influencer, die er in strategischen Fragen, komplexen Vertragsangelegenheiten sowie bei Investitionsprojekten begleitet. Dabei zeichnet sich seine Beratung durch einen interdisziplinären Ansatz aus, der juristische Expertise und langjährige unternehmerische Erfahrung miteinander verbindet. Ziel seiner Tätigkeit ist stets, Mandanten praxisorientierte Lösungen anzubieten und rechtlich fundierte Unterstützung bei der Umsetzung innovativer Geschäftsmodelle zu gewährleisten.

Tags: Consumer Consumer protection Regulation Sicherheit