to the In-Vitro Diagnostic Device Regulation (IVDR)
Demystify the new EU medical device regulations
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 LRQA training courses, this will be delivered by trained and qualified tutors with deep sector-specific technical expertise.
You need this course if...
You are jointly or fully responsible for regulatory compliance working in an organisation involved in any aspects of in vitro diagnostic device manufacturing, designing, marketing or the supply chain and you want:
- To learn why are we moving from a Directive to a regulation, including understanding the background to the changes.
- To understand what the new regulation is trying to achieve. Its key objectives and purpose.
- To identify what the important changes are and their relevance to you as a manufacturer.
- To start the process of building your transition plan for certification to the new regulation.
You will learn...
- The new structure and revised scope of the IVDR.
- New classification rules based on risk.
- Understanding the role of the safety and performance requirements as the basis for CE marking.
- How 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.
You will need...
- Ideally to possess a basic knowledge of medical device use or manufacture.
Your future development
- Introduction to the new Medical Device Regulation (MDR)
- IVDR Implementation
- MDR Introduction
- MDR Implementation
- ISO 13485:2016 courses
- ISO 14971:2012 courses