A CE mark is required for all new products that are subject to one or more of the EU Directives or Regulations (e.g., EU MDR 2017/745 and EU IVDR 2017/746). Most new products that are marketed and sold in the European Economic Area (EEA) will require a CE mark.
*Source: ies.co.uk
To obtain CE certification for your medical device, perform the following steps:
*Source: emergobyul.com
Your CE mark should be affixed to the actual device or to its data plate. If this is not feasible, the CE mark should appear on the product packaging and accompanying documentation.
*Source: cemarking.net
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