Module 16 2024

17/10/2024

The role of economic operators

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The role of economic operators

Article 2(35) - ‘economic operator’ means a manufacturer, an authorized representative , an i mporter , a distributor or the person referred to in Article 22(1) and 22(3);

The authorized representative (AR), importer and distributors must:

• Inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device

• Support the resolution of complaints, including customer communications

• Prevent devices from being placed on the market that do not meet the requirements of the regulation

• Co-operate with the Competent Authority as the manufacturer's representative (AR)

• Have a written contract/mandate with the legal manufacturer which covers all PMS/Vigilance responsibilities

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