Learn about the structure and scope of the IVDR including classification and conformity routes, safety and performance requirements, and how to develop a robust post-market surveillance system under the IVDR.
Who should attend?
Individuals responsible for regulatory compliance working in an organisation involved in any aspects of in vitro diagnostic device manufacturing, designing, marketing or the supply chain.
What will you learn?
- To apply the requirements of EU 2017/746
- The European regulation CE marking approach for medical devices including its legal and operational basis
- Structure and scope of the IVDR including classification and conformity routes
- To review the safety and performance requirements checklist applicable to CE marking under the new regulation
- Create technical documentation to support the product throughout its life cycle
- Level of clinical evidence necessary to demonstrate conformity
- Develop a robust and proactive post market surveillance system under the new IVDR including vigilance reporting and monitoring
- Regulatory significance of a robust quality management and risk management system
- To gather the business impacts of the regulation and start to develop a transition plan.
What do you need to prepare?
- Basic knowledge of medical device manufacturing, design and marketing with a detailed understanding of quality management systems
- Ideally to have attended LR’s Introduction to the Medical Device Regulation (MDR) prior to attending this training course.
- Training course materials
- Lunch and refreshments for public attendees only
- Certificate of attendance.