Unique Skill ID: KS7G29Z6L31J5YSP9P55

Medical Device Directive

The Medical Device Directive is a European Union regulation that sets standards for the safety and effectiveness of medical devices sold within the EU. Compliance with the directive is essential for manufacturers, importers, and distributors of medical devices, and requires a specialized skill set in understanding the legal and technical requirements of the directive. This includes knowledge of product classification, risk assessment, conformity assessment procedures, and ongoing quality management systems. Proper adherence to the Medical Device Directive ensures that patients receive safe and effective medical products, and also protects manufacturers from legal liabilities.

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