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 in person.
Suitable for
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
Benefits to delegates
This course will enable you to:
- Demonstrate a critical understanding of the regulatory environment in the EU and other territories and critically evaluate how these compare
- Critically evaluate the challenges involved in conducting clinical evidence studies using IVD products, giving consideration to the differences between these products and other medical devices in the design and production of clinical data
- Demonstrate critical understanding of the quality system requirements associated with the manufacture and supply of IVDs
- Demonstrate critical understanding of the roles of the different stakeholders involved in the manufacture, supply and regulation of IVDs
- Be able to recommend development strategies for IVD products that will meet global requirements
- Explain the regulatory requirements for vigilance and post-market surveillance for IVDs and be able to make recommendations about the implementation of a surveillance strategy
- Explain the regulatory requirements for the development of an IVD medical device and be able to guide the preparation of the IVD technical documentation needed for CE Marking
- Critically appraise and evaluate communications from regulatory bodies and research publications regarding IVDs
CPD: This course provides 15 CPD hours upon successful completion.
To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.
Programme
You can view and download the programme here.
Module Leaders
Presenters
The expert presenters for this training course are:
Pricing
| Standard training course registration fees |
| Event Registration Type |
Price (GBP) |
Standard Price
TOPRA Member |
£1,900.00 + VAT* |
Standard Price
Non-member |
£2,100.00 + VAT* |
TOPRA MSc Students
|
£1,650.00 + VAT* |
*VAT, where applicable, is charged at the rate of 20%.
| Discounted training course registration fees |
| Event Registration Type |
Price (GBP) |
Government or academic rates
TOPRA Member
|
£1,425.00 + VAT* |
Government or academic rates
Non-member
|
£1,781.25 + VAT* |
Charities, patient groups, full-time education rates
TOPRA Member |
£950.00 + VAT* |
Charities, patient groups, full-time education rates
Non-member
|
£1,187.50 + VAT* |
Places are also available for those in low-income countries as defined by the World Bank.
*VAT, where applicable, is charged at the rate of 20%.
Please email meetings@topra.org for a discount code before making your booking.
Terms and conditions
By booking a place on this course you are agreeing to the training terms and conditions.