Hi everyone,
Can you please confirm if the MDR provides any specific details (clauses,etc) around FSCA decisions and liability?
Is the legal manufacturer soley response for recalls/FSCA, or is liability distributed among economic operators (AR, importer and distributor) since each is verifying conformance to MDR?
Thank you!
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Akanksha Asbe
Regulatory Affairs Specialist II
Clinton MA
United States
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