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Whitepaper

Traceability Requirements under EU MDR

Ensuring traceability at all stages of development and even post-marketing is necessary for medical device manufacturers with products in the EU. EU MDR prioritizes “closed-loop traceability” and if manufacturers can achieve this then they will be highly benefitted. This helps in reducing device hazard risks that increasingly threaten Europe’s aging population.

Topics covered in this comprehensive White paper include:

  • Common Areas Regarding EU MDR Traceability Requirements
  • EU MDR Impact on Coding and Marking
  • Types of Coding and Marking
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