The defendant was a wholesaler of:
- fabric masks with cartoon motifs, which covered the mouth and nose; and
- 'mouth and nose' masks, which were resold to the retail trade.
The applicant asserted claims for injunctive relief under unfair competition law in relation to the distribution of these masks. Her application for an injunction was successful before the regional court insofar as it was directed against the distribution of the 'mouth and nose' masks. With immediate appeal, the applicant contested the part of the regional court's order that dismissed her claims concerning the fabric masks.
The applicant claimed that the fabric masks were medical devices within the meaning of Section 3.1 of the Act on Medical Devices (MPG), because:
- it was possible that they had been displayed in the retail trade alongside face masks that looked like medical masks; and
- in the opinion of the scientific community, the legislature of the ordinance on protection against infection and the targeted public, they were considered to have a protective effect against the spread of COVID-19.
The applicant further claimed that the defendant had not complied with the provisions of the MPG on the distribution of medical devices. If the fabric masks were not medical devices, the defendant should have clarified this or indicated that they served non-medical purposes at the point of sale.
The Hamm Higher Regional Court rejected the applicant's immediate appeal as unfounded.
The fabric masks did not constitute medical devices within the meaning of Section 3.1 of the MPG because they lacked a medical purpose that was defined by the manufacturer. The possibility of the fabric masks being displayed alongside medical face masks in the retail trade was inconsequential, because this was not attributable to the defendant. Nor was it decisive if the public attributed to the masks a protective effect against the spread of COVID-19, because the defendant did not envisage this medical purpose. Moreover, the Federal Institute for Drugs and Medical Devices was also of the opinion that fabric masks in the form of mere everyday masks were not medical devices.
It was not necessary to clarify that the fabric masks were not medical devices or that they served non-medical purposes. The public did not get the impression that they were medical devices. Instructions for use or other information were not necessary, because no special rules had to be observed when using them.
While the court's decision did not reinvent the wheel of product law, it dealt with an important issue in a clear manner.
Its statements on the qualification of fabric masks as medical devices were convincing. They aligned with established case law, which states that the qualification of a medical device depends on the manufacturer's subjective purpose, as established by the information that the public takes from:
- the labelling;
- the usage instructions; or
- the advertising.(1)
The court also issued clear explanations on the implications of:
- displaying fabric masks alongside medical face masks; and
- any protective effects that are attributed to the fabric masks.
The court's finding that the defendant did not have to clarify what the fabric masks were not was also correct. A contrary view would have strange consequences: even throat sweets would have to be labelled as not a medical device.
However, further clarification would have been desirable, for example to what extent the court took into account the comic motifs of the fabric masks when classifying them and how this would relate to medical products that are intentionally trivialised (eg, decorative plasters for children).
The decision showed the importance of labelling, presentation and the placement of products on the market and highlighted the pitfalls that lurk in this area.
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