💡 The Medical Device Coordination Group has published the MDCG 2019-15 guidance for manufacturers of Class I medical devices.
The MDCG recommends the establishement of a quality management system that includes:
– A strategy for regulatory compliance,
– Identification of applicable general safety and performance requirements,
– Responsibility of the management,
– Resource management,
– Risk management,
– Clinical evaluation,
– Product realisation, including planning, design, development, production and service provision,
– Verification of the UDI assignments,
– Establishing a post-market surveillance system,
– Handling communication with all stakeholders,
– Processes for reporting serious incidents and field safety corrective actions,
– Management of corrective and preventive actions and verification of their effectiveness,
– Processes for monitoring and implementing product improvement.