Similarities and Differences between Medical Device 510(k) and CE Marking

This article highlights some of the similarities and differences between the Medical Device 510(k) and CE Marking regulatory pathways and helps harmonise some aspects of an overall regulatory strategy. Editor’s Note: This article updates and replaces Vincent Crabtree’s 2014 blog on 510(k) and CE Marking (Pt 1 and Pt 2). FDA has a clear definition […]

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