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.
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