Management system requirements

The quality management system shall at least solve the following problems:

(a)   Regulatory compliance strategy, including the conformity of the compliance evaluation process and the change management procedure for the devices covered by the system;

(b)   Determine applicable general safety and performance requirements and find alternative methods to meet these requirements;

(c)   Management responsibility;

(d)   Resource management, including selection and management of suppliers and subcontractors;

(e)   Risk management as specified in Section 3 of Annex I;

(f)   Clinical evaluation, including PMCF in accordance with Article 61 and Annex XIV;

(g)   Product realization planning, including planning, design, research & development, production and service provision;

(h)   Verify the UDI allocation of all related devices in accordance with Article 27(3), and ensure the consistency and validity of the information provided in accordance with Article 29;

(i)    Establish, implement and maintain the post-market surveillance system in accordance with the requirements of Article 83;

(j)   Communicate with competent authorities, notified bodies, other economic operators, customers and/or other stakeholders;

(k)   Reporting procedure for serious events and on-site safety corrective actions under vigilance;

(l)    Management and effectiveness verification of corrective and preventive actions;

(m)  Product surveillance and measurement process, data analysis, and product improvement.