The company TMK Retail Service & Consulting GmbH, established in 2014, provides manufacturers, importers and retailers with external quality management services for non-food products. The objective is to proactively accompany the manufacturing or procurement process and to help verify all aspects of product marketability. This means that TMK customers are protected as far as possible from legal warning letters and can successfully focus on sourcing new customers and developing new fields of activity. TMK is independent of inspection institutes, combining many years’ expertise with modern process management and thus enabling customers to obtain product conformity at low prices.
Distributors of e-cigarettes must always ensure that all ingredients they contain are known and declared. Germany’s state investigation offices carry out random checks in this regard. Recommendation: Not only does e-cigarette hardware need to be marketed in full legal compliance; special attention must also be paid to the liquids used.
A simplified test procedure for the approval of PPE masks as medical masks has already been in place since the corona pandemic began. The Central Office of the Federal States for Safety Technology (ZLS) has now published a new revision of the test procedure with the issue date 2 June 2020. The new features include additional criteria for labelling the masks. TMK Retail Service & Consulting GmbH will support you in selecting a suitable market access procedure and evaluating the necessary documentation.
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.