Common pitfalls during the CE marking of a Medical Device or IVD
A CE (Conformitè Europenne) Mark is mandatory for medical devices manufactured, designed, marketed, and supplied within the European Economic Area (EEA) & European Union (EU). The CE Mark is a representation of the manufacturer’s declaration that the product complies with the EU’s applicable directives/regulations. Compared to the MDD & IVDD, the current MDR 2017/745 &…
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