Selling medical respiratory masks without CE marks

While so-called “community masks” without the CE mark can be placed on the market, these are not suitable for use in the clinical sector, for instance. However, for medical respiratory masks which are also marketable in the United States of America, Canada, Australia or Japan, Section 11 (1) of the German Medical Devices Act allows the competent authority to issue special permits and, where necessary or applicable, also to declare such masks without CE marks as marketable in Germany.

According to the German Medical Devices Act (Medizinproduktegesetz - MPG), respiratory masks that are to be marketed within this framework must meet the relevant requirements. In particular, they must bear the CE mark.

If the CE mark is lacking, problems may arise with customs, especially when importing such masks into the EU. While so-called “community masks” without the CE mark can be placed on the market, these are not suitable for use in the clinical sector, for instance. However, for medical respiratory masks which are also marketable in the United States of America, Canada, Australia or Japan,  Section 11 (1) of the MPG allows the competent authority to issue special permits and, where necessary or applicable, also to declare such masks without CE marks as marketable in Germany.

Recommendation: Importers of medical respiratory masks affected must comply with the requirements of the Medical Devices Act. Register the products concerned, including the relevant test certificates or foreign approval certificates, for special approval at medizinprodukte@bfarm.de

TMK Retail Service & Consulting GmbH will advise you on the preparation of the documents for submission. Boris Berndt at TMK will be pleased to answer your questions; please phone +49/40/54090410-8 or send an e-mail message to info@retailconsult.info.

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