Mask yourself!
The debate about whether wearing face masks can really help in preventing the spread of COVID-19 or not is ongoing and hot. Fact is that in many of the affected areas - such as Austria, just to name one - masks have been made mandatory. The problem is: often masks are simply not available and pharmacies do not get enough supplies.
Do it yourself
For this reason, many people have enganged in often rather pittoresque attempts at fabricating their own masks using diverse materials, ranging from scarves to female absorbents. Also companies in some of the COVID-19 hotspots, such as Italy’s Calzedonia group or Spain’s Zara, have partly reconverted production to face masks. But are there any requirements when distributing face masks to public?
Face masks are medical devices
As per art. 1 par. 2 of the European Directive on medical devices no. 93/42/EEC any instrument that helps in preventing a disease is considered a “medical device”. The EU member states have passed national legislation to implement the directive. In the case of Germany, most provisions are to be found in the Medizinproduktegesetz (MPG). All in all, however, the legal framework is broadly comparable in all EU states.
In brief, considering face masks as medical devices means that before being put on the market (regardless of whether this happens for free or at a cost) they must be clinically tested and approved by the competent authorities. In addition, they must comply with a long list of safety and compatibility requirements and bare the well-known “CE” seal.
Under German law, producers of medical devices are also obliged to declare their activity to the competent authorities.
Finding a workaround
Quite obviously, companies whose main business is not the production of medical devices will hardly be capable of meeting all those requirements in such a short time as to be still useful to face the current emergency. In some cases (e.g. in Italy), governments have temporarily easened the requirements to put masks on the market in order to allow for a quicker response.
But wherever governmental action has not been taken, the only option is a workaround: face masks may be produced and sold (or given out for free) as by making sure that they are not advertised as “medical face masks”.
Details matter
It’s however not sufficient to simply declare that a mask is no “medical device”, if the way it’s advertised, including wording, pictures, context, descriptions etc. etc. clearly suggest that it helps in preventing contagion - because that would be exactly what a medical device is defined by.
Therefore, the utmost care must be used when describing the masks: no element may mislead customers into thinking that they are buying a disease-preventing instrument. Definitions such as “protective face mask” or “protective device”, let alone “medical mask”, may very well be regarded as misleading, while simply defining the product as “mask” or “face mask” should prove legally safe.
The same reasoning must be obviously applied to descriptions, pictures and any additional documentation: masks must basically be treated as standard clothing accessories, without any medical purpose or function.
Risks
Given the circumstances, offering masks to public may easily land in the limelight of public health, competition and consumer protection authorities and result in audits, sanctions or, as the case may be, even criminal investigations.
In addition, in Germany (and in any other country with a similar legal framework), competitors are entitled to exercise unfair competition claims: medical devices producers may therefore sue such newcomer masks producers for misleading the market, if the above-mentioned conditions are not met.