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Preconference Workshop: Effective Risk Management at the Core of MDR and IVDR

Tuesday, October 22, 2024
9:00 AM - 5:00 PM CEST
Location/Room: Sants - 3rd fl

Description:
A safe and effective product is a basic and universal user need. It is also the foundation for most medical device regulatory requirements around the world. For example, Essential Principles, Essential Requirements and General Safety and Performance Requirements are mostly a set of hazards and hazardous situations that manufacturers must consider and work to control for their specific device. With each passing year and each serious incident or recall, the importance of safety, and thus risk, has gained increasing focus as regulations have matured over the years. For example, the Medical Devices Directive 93/42/EEC and the In Vitro Diagnostic Devices Directive 98/79/EC each contained approximately 50 references to risk, whereas the Medical Devices Regulation 2017/745 and In Vitro Diagnostics Devices Regulation 2017/746 each contain over 200 references to risk throughout their many articles and annexes.
ISO 14971:2019 provides a framework and requirements for a risk management system for medical devices, but it is not, and cannot be, prescriptive on how to implement for every single device type and organisation in the medical device industry. This workshop is designed for those attendees with some existing risk management experience who want more, and is intended to provide delegates with practical guidance and knowledge on the implementation of risk management throughout the device life cycle, to ensure that their teams can get the most out of their risk management processes. The presenters will discuss requirements, common Notified Body findings and advice on clear actions based upon best practice. In particular, the workshop will delve into topics such as:

• Beyond regulatory compliance: An exploration of the connections needed between various parts of the risk management process, EU Technical Documentation and the Quality Management System.
• Tools and techniques: You cannot build a house with only a hammer, so it is important to understand what tools are available in your risk management toolbox and when/how to use them.
• Knowing your audience: Communication within risk management is often overlooked but is vital to ensure that we develop a safe product, can manage the device through its lifecycle, can demonstrate regulatory compliance and can provide users with the information that they need.
• Understanding uncertainty: How does the cumulative effect of uncertainty throughout the design & development process affect the acceptability decisions in our benefit risk determination?
• The importance of state of the art: not just for Clinical Evaluations and Performance Evaluations, an understanding of the state of the art is critical throughout design & development, risk management, clinical evaluation and post-market surveillance.
• Sustaining risk management: A common issue identified by EU Notified Bodies is the poor or missing connection between risk management and post-market surveillance. There are some simple, and not so simple, methods to deploy to avoid these much-repeated mistakes.

Attendees will come away with tips and practical solutions for:
• Applying risk management tools to identify hazards and hazardous situations;
• Constructing your risk management files;
• Using your risk management process to support submissions for clinical investigations;
• Implementing your risk management process into your quality management system and post-market surveillance processes.

Preliminary Agenda
9:00 - 10:30: Welcome
• Introductions
• Risk Management Basics
• Risk management for MDR 2017/745 & IVDR 2017/746
• EN ISO 14971:2019+A11:2021 overview
• Risk Management Planning
10.30 – 11:00 Break
11:00 – 12:30 Risk Analysis (inc. State of the art, tools, use of standards), Risk Assessment and Risk Controls
12:30 – 13:30 Lunch
13:30 – 15:00 Benefit-Risk Evaluation (inc. state of the art, uncertainty)
15:00 – 15:30 Break
15:30 – 16:30 Post-Market Surveillance

Learning Objectives:

  • The requirements for risk management within EU MDR 2017/745 & IVDR 2017/746;
  • The differences between EN ISO 14971 and ISO 14971, and the status of EN ISO 14971 in the EU;
  • The role of risk management within a Quality Management System;
  • The interactions between risk management, design & development, clinical evaluation and post-market surveillance;
  • Common findings and non-conformances related to risk management activities.