BfArM special approval of masks was restricted

Up until now, it has been possible to market dust protective breathing masks with test certificates for FFP2, KN95 or N95 as medical devices for customers in the healthcare sector by special approval from the Federal Institute for Drugs and Medical Devices (BfArM). According to the BfArM, many masks were unfortunately put into circulation via this route with the aid of forged certificates that fail to meet what they promise. In addition, the market is once again sufficiently supplied with regularly certified masks, which means that special approval will only be granted for masks for which a test certificate in conformity the corona test procedures of the Central Office of the Federal States for Safety Technology (ZLS) is in hand. Accordingly, for the time being KN95 or N95 respiratory masks are no longer marketable as medical devices without verification. TMK Retail Service & Consulting GmbH supports you by reviewing the available documents, estimating the costs and selecting possible market access.

Up until now, it has been possible to market dust protective breathing masks with test certificates for FFP2, KN95 or N95 as medical devices for customers in the healthcare sector by special approval from the Federal Institute for Drugs and Medical Devices (BfArM). According to the BfArM, many masks were unfortunately put into circulation via this route with the aid of forged certificates that fail to meet what they promise. In addition, the market is once again sufficiently supplied with regularly certified masks, which means that special approval will only be granted for masks for which a test certificate in conformity the corona test procedures of the Central Office of the Federal States for Safety Technology (ZLS) is in hand. Accordingly, for the time being KN95 or N95 respiratory masks are no longer marketable as medical devices without verification.

This applies to manufacturers and importers of oronasal breathing masks.

Requirements: Medical Products Directive 93/42/EEC

Recommendation: Before marketing, parties affected should be aware of which market access channels are open for their particular product. TMK Retail Service & Consulting GmbH supports you by reviewing the available documents, estimating the costs and selecting possible market access.

Boris Berndt at TMK will be pleased to answer your questions; please call +49/40/54090410-8 or send an e-mail message to info@retailconsult.info.