Regulatory Requirements for Design and Manufacture of Medical Devices, 5 op

Core content

• Regulatory framework for medical devices in the European Union
• General safety and performance requirements for medical devices
• Quality management system for medical devices
• Conformity assessment
• Post-market surveillance

Complementary knowledge

• Understanding the basic definitions and key concepts of the Regulations on medical devices and the requirements for economic operators
• Understanding the use of harmonised standards and the requirements for a risk management system and clinical evaluation
• Understanding of technical documentation and the requirements for a quality management system (with a reference to the standard EN ISO 13485:2016)
• Understanding the relation of the classification rules to the conformity assessment procedures and the role of conformity assessment bodies
• Understanding the requirements for registration, traceability and vigilance system, and the role of Competent Authorities in market surveillance