What are the duties and responsibilities of a medical device manufacturer?

1. Design and manufacture products in accordance with regulatory requirements;

2. Establish, document, implement, and maintain a risk management system;

3. Conduct clinical evaluations, including PMCF (Post-Market Clinical Follow-Up Guidelines);

4. Prepare, control, update, etc., technical documentation;

5. Conduct declarations of compliance;

6. p>6. UDI (Unique Identification of Medical Devices) and registration;

7. Determination of conformity assessment pathways;

8. Conducting post-marketing tracking/vigilance systems;

9. Ensuring compliance with the relevant EU directives and the relevant laws of its member states;

10. Establishment and maintenance of a quality management system.