The Medical Device Regulation (MDR (EU) 2017/745) and the In Vitro Diagnostic Medical Device Regulation (IVDR (EU) 2017/746) are the two Regulations which define product categories requiring CE marking.

How to reproduce the CE mark
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All medical devices, with the exception of the risk class I, require the involvement of a so-called Notified Body. MDSS Consulting GmbH supports you with determining whether your device falls under one of the relevant directives or whether it is instead a cosmetic product, a biocidal product or a medicinal product.

Our expert team supports you from the beginning up to the successful declaration of conformity, including the affixing of the CE mark.