Module 15 2022

19/05/2022

MDR PMS requirements

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 6

7

MDR PMS requirements – QMS process

• Article 83 describes the requirement for the post-market surveillance (PMS) system: • For each device, manufacturers shall plan, establish, document, implement, maintain and update a post-market surveillance system in a manner that is proportionate to the risk class and appropriate for the type of device. • The system shall be an integral part of the manufacturer’s quality management system • It must actively and systematically gather, record and analyse relevant data on the quality, performance and safety of the device • Data must be gathered throughout the entire lifetime of the device • The necessary conclusions shall be drawn including determining, implementing and monitoring corrective and preventative actions

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 6

8

4