IVDR management system requirements

IVD will be divided into 4 classes according to the risk level 

Example of management system process diagram


IVDR management system

The IVDR is an opportunity to take an objective look at the QMS to ensure that it meets the business goals while delivering all of the pieces necessary for compliance. In particular, under the IVDR, the QMS must contain at least: 

· a strategy for regulatory compliance 

· identification of applicable general safety and performance requirements 

· management responsibility 

· resource management, including selection and control of suppliers and subcontractors 

· risk management 

· performance evaluation, including PMPF 

· product realization, including planning, design, development, production and service provision 

· verification of the UDI assignments 

· setting-up, implementation and maintenance of a post-market surveillance system 

· handling communication with competent authorities, notified bodies, other economic operators, customers and/ or other stakeholders 

· processes for reporting of serious incidents and field safety corrective actions in the context of vigilance 

· management of corrective and preventive actions and verification of their effectiveness 

· processes for monitoring and measurement of output, data analysis and product improvement. Remember, the QMS is in place to support the business to achieve its goals and not as an entity on its own.