- Self-made respiratory masks are Class I medical devices and are subject to the Medical Devices Act.
- The designation of masks as protection should be avoided in order to prevent warnings.
- Homemade masks must make it clear that they do not offer sufficient protection.
- If offered commercially, imprint, data protection and consumer protection notices are required.
- Labeling in accordance with the Product Safety Act is necessary to avoid legal problems.
- Legal regulations must not be carelessly ignored in order to avoid legal proceedings.
- Caution and thoughtfulness are crucial before respiratory masks are offered online.
0Currently, there is demand everywhere for protective clothing such as respirators and, in addition to professional suppliers, numerous self-employed people are also entering the market and want to offer their own products via the Internet. But what do I need to pay attention to?
Currently, warnings are threatening, and probably some have already been sent, if you offer self-manufactured respiratory masks on platforms such as Ebay, Amazon or even in your own online store. Indeed, mouth masks and respirators are in principle Class I medical devices. The Medical Devices Act is therefore applicable to these. In any case, if it is intended by the supplier for use by humans for the purpose of preventing disease.This determination can be made, for example, as part of the description of the product on the platforms and if only to be found better through search engines (because you use the term Covid-19 or Corona) or to justify a higher price.
Even the name of the product as such is sufficient, which is why, for example, the word “protection” should not be used in any combination.
It is therefore imperative to refrain from presenting them as medical devices, and it must also be made absolutely clear that homemade masks probably do not offer any kind of adequate protection and must not be used professionally. Handle this differently, and you have to provide things like a CE mark, instructions for use, and other information, and of course put the mask through extensive testing.
Of course, other requirements should not be ignored. If you act commercially, and this is achieved more quickly than many suspect, things like imprint, data protection, consumer protection information and the statutory right of withdrawal must be observed. But also the labeling of the products with name and address according to the product safety law must probably be present, if one wants to prevent expensive warnings. Things like tax registration, accounting, business registrations and the like should also be considered if you want to appear publicly via platforms and not just produce 5-10 masks for family, close friends or the like.
In many places on the Internet, one now reads that it is now important to manufacture things like breathing masks at all, that laws should now not be applied so strictly and that warning about the MPG (Medical Devices Act) would be typical lawyer. I can only warn against this attitude. This opinion will not be heard by courts, even after the crisis is over. This is especially true because it is not forbidden in the least to offer masks over the Internet. The only thing is that the offer must not mislead consumers or suggest that these masks have any medical purpose, have any effect or can be used for any special purpose. Of course, this has an impact on the findability via search options and the level of the price. But you also save trouble with the MPG!
Therefore, proceed carefully and thoughtfully when offering, before the big check comes at some point!
