Module 15 2022

19/05/2022

MDR PMS requirements – QMS process

• Article 83 requires the PMS data to be used to: • Update the risk management • Update the design and manufacturing information, the IFU and labelling • Update the clinical evaluation • Update the Summary of Safety and Clinical Performance (SSCP) • Identify the need for Corrective or Preventative Action (CAPA) or Field Safety Corrective Action (FSCA)

• Identify options to improve usability, safety and performance • Contribute to the PMS of other devices (equivalent or similar) • To detect and report trends

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 6

9

MDR PMS requirements - planning

• Article 84 Post-market surveillance plan • Requires a PMS plan to be established as per the requirements in Annex III, Section 1

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 6

10

5