Introduction 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 organization. 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 a senior manager, or regulatory / research / design / development / manufacturing / marketing manager, working for an organization producing in-vitro diagnostic devices, or a distributor of in-vitro diagnostic devices, and you want:
- To learn about the implications of the EU Referendum.
- An overview of the new IVDR and the negotiations leading up to its impending publication.
- To understand the key changes introduced.
- To start thinking about implementing the new regulation.
- To prepare your organization for foreseeable challenges ahead.
You will need:
- Ideally to possess a basic knowledge of in-vitro diagnostic device use or manufacture.
You will learn:
- The European CE marking approach with respect to IVDs.
- The structure and scope of the IVDR.
- What an in-vitro diagnostic device (IVD) is.
- To classify IVDs and determine appropriate conformity routes.
- The role of essential requirements as the basis for CE marking including the use of standards and an awareness of the technical documentation to support compliance.
- The requirements for performance evaluation.
- The necessary steps required for post-market surveillance and the reporting of adverse incidents under the vigilance system.
Your future development
- Introduction to the new Medical Device Regulation (MDR)
- MDR Implementation
- IVDR Implementation
Dates and Locations