This course is also available to attend in-person.
When: 9 June 2026
Where: Online
Time: 09:00-16:00 GMT
CPD: 6 CPD hours upon successful completion
Who should attend
This course is ideal for:
- Regulatory affairs professionals seeking an introduction to IVD devices
- Professionals in marketing, medical, quality, legal, or related roles working with IVDs
- Employees of regulatory authorities or others in the IVD regulatory sector
What you'll learn
By completing this course, you will be able to:
- Understand the regulatory environment for IVDs and how regulations and controlling documents are applied
- Identify key regulated markets and the main regulatory authorities for IVDs
- Understand the key elements of product performance (General principles of Safety and Performance)
- Learn the principles of labelling and documentation requirements
- Understand the purpose and maintenance of product files
- Gain insight into submissions, certifications, and the approval process
Course overview
This course is designed to help regulatory affairs professionals master the fundamentals of in vitro diagnostics.
It provides a comprehensive overview of the regulatory environment, covering key regulatory processes and issues related to IVDs. The course aims to build confidence in communicating the basics of IVDs within the context of regulatory affairs and grow your career.
Download Programme
Course presenters
The other expert presenters for this course are:
Pricing
| Standard training course registration fees |
| Event Registration Type |
Price (GBP) |
Standard Price
TOPRA Member |
£650.00 + VAT* |
Standard Price
Non-member |
£910.00 + VAT* |
Those working for regulatory or government agencies, academic institutions, charities, patient groups, emerging markets, and MSEs (Micro and Small Enterprises) can also access discounted rates by becoming a TOPRA member. For more information about the discounts available, please email meetings@topra.org before making your booking.
Important Notice On VAT
In compliance with regulations, a *20% VAT will be charged to attendees only where applicable. If you have a VAT number or if the company or organisation you are affiliated with has a VAT number or equivalent please ensure it is visible on your profile. If your VAT number is not visible on your profile, please email finance@topra.org to have it updated. If you do not have a VAT number, there is no action required — VAT will be applied accordingly during the registration process. Please observe that the VAT number needs to be valid.
Click here to check and validate your VAT number.
For EU countries; if you are unsure of the VAT number, click here to check and validate your VAT number.
Terms and conditions
By booking a place on this course you are agreeing to the Training Terms and Conditions.