Module 15 2022

19/05/2022

MDR PMS requirements - planning

• Annex III, Section 1(a), Technical Documentation of Post-Market Surveillance: • The plan shall address the collection and utilisation of the available information including: • Information concerning serious incidents • Records referring to non-serious incidents • Data on any undesirable side-effects • Information from trend reporting • Feedback and complaints from users, distributors and importers • Relevant information from literature, databases and/or registers (PMCF) • Publicly available information about similar devices (PMCF)

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 6

11

MDR PMS requirements - planning

• Annex III, Section 1(b), Technical Documentation of Post-Market Surveillance • The plan shall cover: • A proactive and systematic process to collect the post-market data • Effective and appropriate methods to assess the data • Suitable indicators and threshold values for use in the continuous assessment of risk • Methods and tools to investigate and analyse complaints • Methods and protocols to determine trends and identify any statistically significant increase in frequency of severity of incidents • Effective methods of communication to Competent Authorities, Notified Bodies, Economic Operators and users • Reference to procedures covering PMS, planning and the PSUR • Procedures to identify and initiate appropriate corrective/preventative actions • Tools to trace and identify devices (traceability) • PMCF plan as per Annex XIV, Part B

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 6

12

6