Requirements relating to Breathing Masks from Manufactories (“community masks”)

The provision of breathing masks from manufactories (“community masks”) is possible if certain rules are followed. The decisive factor is the correct labelling of the masks, which must be clearly distinguishable from medical products or personal protective equipment. Affected manufacturers and importers of breathing masks that do not comply with the Medical Products Act must observe the requirements of the Product Safety Act.

The scarcity of protective equipment for personal use in times of the corona pandemic, especially breathing masks, induces many manufacturers to alleviate this need and provide face masks for end customers. The manufacturers’ aim is to meet the level of demand as fast as possible. As a rule, there is not enough time to prove compliance with legal regulations, e.g. the Medical Products Act.

The provision of such masks referred to as “community masks” is nevertheless possible if certain rules are complied with. The decisive factor is the correct labelling of the masks, which must be clearly distinguishable from medical products or personal protective equipment.

Affected manufacturers and importers of breathing masks that do not comply with the Medical Products Act must observe the requirements of the Product Safety Act.

Recommendation: “Community masks" must likewise be labelled in accordance with the law. TMK Retail Service & Consulting GmbH will advise you quickly and unbureaucratically on the correct labelling of your “community mask”. If you have any questions, please call Boris Berndt on +49/40/54090410-8 or send an e-mail message to info@retailconsult.info.