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Medical Devices

IMDRF Coding: Complaints, Vigilance, Trend Analysis, and the Benefits of Codifying Your Post Market Surveillance System

Wednesday, May 8, 2024
14:00 – 15:00 CEST
Location: B 05 + B 06
Learning Level: Advanced

Description: Complaints, vigilance and trend analysis are mandatory areas for all medical device manufacturers quality and regulatory system. Post market surveillance and in particular an efficient safety reporting system finds increasing emphasis in the global regulatory space in the updated regulations. Participants of this presentation will not only learn how a complaints and vigilance system should be set up to ensure efficient safety reporting but they will also understand how codifying the system will benefit their own product and enable objectivity in their early warning system to override potential human error. Participants will learn the details within applicable guidance including MDCG vigilance guidance (MDCG 2023-3 Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices) will be studied as well as IMDRF Adverse

Event Coding Guidance (IMDRF/AE WG/N43FINAL:2020 (Edition 4)), Meddev guidance (MEDDEV 2.12/1 rev.8 (763 kB) Guidelines on a medical devices vigilance system) as well as the expected requirements in the future UK regulations. The session will not go into detail about all different global requirements, however and overview will be presented, and the focus will instead be on the in-house process which analyses data and uses specific universal codes to ensure compliance and an objective unbiased type of analysis for the devices performance and safety in the field. The benefits of objectivity in this process will be discussed with links to the risk management system and ISO 14971: 2019 as well as product liability legislation in the EU/UK and overall risk awareness.

Learning Objectives:

  • Upon completion participants will be able to codify their feedback system to ensure an objective and unbiased analysis of safety and performance can take place.
  • Upon completion participants will be able to understand vigilance process requirements for global compliance.
  • Upon completion participants will be able to apply the theory discussed to their own quality management system to help remove human error improve their post market surveillance system and risk management process also.