Before placing medical devices (MD), in vitro diagnostic devices (IVD) and implantable medical devices on the European market, the manufacturer has to affix the CE mark to the products.
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
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 itis 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.