Section 3: Quality Management System (QMS) Requirements

Implementing and maintaining a quality management system (QMS) is mandatory for manufacturers looking to market and sell medical devices in the EU. Several new QMS requirements have been introduced under the IVDR. These new requirements will apply to both existing and new devices that are brought to market.

The QMS should address the following under the new regulation:

• Defined strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for the management of device modifications 
• Designated “person responsible for regulatory compliance” 
• System for identifying all applicable general safety and performance requirements 
• Product realization—planning, design, development, production, and service provision 
• Management of resources (i.e., infrastructure and equipment) and supply chain 
• Development of a risk management plan 
• Process for post-market surveillance 
• Process for performance evaluation and post-market performance follow-up 
• Periodic safety update reporting 
• System for serious incidents and corrective action reporting 
• System for managing corrective and preventive actions (CAPAs) and verifying their effectiveness 
• Processes and procedures to support UDI requirements 
• Processes for product improvement, monitoring and measurement of output, and data analysis 
• Process for handling communications with competent authorities, notified bodies, economic operators, customers, and other stakeholders