As a forward-looking manufacturer operating in the highly regulated and high stakes world of medical devices manufacturing, you want to understand the new regulation and its impact on your organisation.
This training course will help you uncover all the key regulatory changes that you need to know Like all other Lloyd's Register training courses, this will be delivered by trained and qualified tutors with deep sector-specific technical expertise.
Who should attend?
- Those who are responsible for regulatory compliance working in an organisation involved in any aspects of medical device manufacturing, designing or marketing and need to learn why we are moving from a Directive to a regulation
- Manufacturers that need to identify the important changes and their relevance
- Anyone in the process of building a transition plan for certification to the new regulation.
What will you learn?
- The new structure and revised scope of the IVDR
- New classification rules based on risk
- The role of the safety and performance requirements as the basis for CE marking
- To determine the appropriate conformity route for your products
- Technical documentation changes and new requirements under the regulation
- The requirements for performance evaluation
- The necessary steps required for post-market surveillance and the reporting of adverse incidents under the vigilance system
- The hot topics under the new regulation including supply chain requirements, your commitment to device identification, defining the person(s) responsible for regulatory activities, new definitions to understand and your timeline to transition.
What do you need to prepare?
Basic knowledge of medical device use or manufacture.
- Training course materials
- Lunch and refreshments for public attendees only
- Certificate of attendance.