TOPRA are holding their 2025 Symposium in Berlin from 30th September – 1st October. The event promises to cover some of the most important topics affecting IVDs and medical devices, particularly those affecting the EU.
You can find the agenda and booking information here.
Please find below information related to TOPRA’s IVD masterclass later on this year.
Regulation of In-Vitro Diagnostics Medical Devices
When: 20-22 October 2025
Where: TOPRA Office, 3rd Floor City Reach, 5 Greenwich View Place London, E14 9NN
This course is also available to attend online.
This course is essential for:
- Delegates from the regulatory affairs industry who wish to develop their knowledge of IVD’s;
- Delegates from allied industries who wish to have a comprehensive understanding of the subject;
- Students of the TOPRA MSc programme.
Note: this course is also Module 19 of the MSc Regulatory Affairs.
Course information
The Masterclass will cover both the current regulatory environment and the new regulations as they come into effect. It will also cover:
- The current EU regulatory environment and a comparison to the regulatory environments in jurisdictions such as Japan, China and Brazil
- Definitions and classification of IVD devices
- Conformity Assessment
- Quality Management Systems
- Risk management
- Technical documentation
- Performance data and product claims
- Post market surveillance, vigilance and FSCA
- Other relevant legislation
- Companion diagnostics and other emerging technologies
You can find agenda and booking information here.
