A simplified test procedure for the approval of PPE masks as medical masks has already been in place since the corona pandemic began. This procedure is always suitable when there is no other test evidence for the efficiency of the mask. 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. For instance, no CE mark may be applied to the mask or its packaging.
This applies to manufacturers and importers of oronasal breathing masks.
Requirements: Medical Needs Health Care Ordinance-MedBVSV
Recommendation: Persons affected should weigh the pros and cons of the various options for placing respiratory masks on the market. While the ZLS test procedure offers relatively fast market access, it may call for a change in the labelling of masks.
TMK Retail Service & Consulting GmbH will support you in selecting a suitable market access procedure and evaluating the necessary documentation.
Boris Berndt at TMK will be pleased to answer your questions; please call +49/40/54090410-8 or send an e-mail message to firstname.lastname@example.org.