White Paper: Economic Operators: Whose Problem Is It Anyway?

Economic operators are a new concept under EU MDR and IVDR. Defined as entities with an economic interest in medical devices, this role has been expanded under the new regulations to include new requirements for importers, distributors, manufacturers, and authorized representatives. Importers and distributors are particularly affected because they were not included in the previous directives at all. 

Legal liability is another area that has manufacturers wondering, whose problem is it? Fortunately, RQM+ has answers.

This white paper covers:

  • New economic operator definitions and how each entity is affected
  • Mapping the supply chain and understanding regulatory requirements so devices can be safely placed on the EU market
  • Successfully navigating new verification responsibilities
  • Benefits of taking a strategic approach to economic operator compliance

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