EU In Vitro Diagnostic Regulation (IVDR)

The In Vitro Diagnostic Medical device directive has partially been replaced by the In Vitro Diagnostic Regulation. The transition period for regulation 2017/746 for IVD devices on the European market is postponed for some processes and some of the products but for other products it is required from 26th of May 2022. The new regulation will have a great impact on all device manufacturers, with stricter requirements on devices as well as on manufacturers’ QMS’s, throughout the product lifecycle.

Topics

• Key differences between IVDD and IVDR
• Classification rules and conformity route
• Time schedule – what is required when
• Technical documentation requirements overview
• General safety and performance requirements (GSPR)
• Post-market surveillance
• UDI and product labelling
• Performance evaluation
• Common specifications
• Impact on quality management systems
• Implementation timeline
• Implementation plan
• How to conduct a gap assessment

Target group

This course is intended for quality and regulatory professionals working with In Vitro Diagnostics, medical device company management and employees who need to learn more about the impact of the IVDR.

Educational goals

After the course, participants will have a basic understanding of the requirements of the new In Vitro Diagnostics Regulation (IVDR) and of its impact on all device manufacturers, with stricter requirements on devices as well as on manufacturers’ quality management systems, throughout the lifecycle of a product.

Course material

Course material will be in English, verbal presentation and discussions in Swedish.

Printed course presentation and a printed spiral bound book of the IVDR Regulation (EU) 2017/746 is included.