This course is also available to attend in-person.
When: 6-8 October 2026
Where: Online
Start time Day 1: 13:30 GMT | End time Day 3: 15:45 GMT
CPD: 19 CPD hours upon successful completion
Who should attend
This course is ideal for:
- Students of the TOPRA MSc programme
- Professionals from the regulatory affairs industry who wish to develop their knowledge of the regulatory and related activities through the lifecycle
- Professionals from allied industries who wish to have a comprehensive understanding of the subject
What you'll learn
By completing this course, you will be able to:
- Critically analyse the legal, regulatory, and quasi-regulatory requirements applicable to medical devices
- Apply good regulatory practice when interacting with regulatory bodies, including the critical appraisal of regulatory communications
- Make informed recommendations on how to prepare for unannounced audits
- Address complex post-market regulatory issues both systematically and creatively, make sound judgements in the absence of complete data, and communicate conclusions clearly to specialist and non-specialist audiences
- Demonstrate a critical understanding of the factors required to maximise the commercial and regulatory success of a medical device
- Understand the importance of intellectual property, data protection, and product liability, and assess when specialist legal advice is required
- Demonstrate a critical understanding of health technology assessment and reimbursement
- Critically evaluate the application of environmental legislation and standards to medical devices throughout their post-market lifecycle
Course overview
Maintaining a medical device’s regulatory and commercial viability after market entry requires a strategic and multidisciplinary approach. This course explores the post-launch regulatory environment, covering advertising compliance, intellectual property, data protection, and environmental legislation. Participants will examine the roles of economic operators, authorised representatives, trade associations, and key concepts such as product liability, reimbursement, and health technology assessment. Case studies and workshops support the development of practical skills in managing ongoing regulatory obligations and future market pressures.
Course presenters
TOPRA Masterclasses are developed and delivered by a faculty of expert speakers from relevant industry, agencies, notified bodies and other stakeholders, and are validated by the University of Hertfordshire.
Pricing
| Standard training course registration fees |
| Event Registration Type |
Price (GBP) |
Standard Price
TOPRA Member |
£1,750.00 + VAT* |
Standard Price
Non-member |
£2,450.00 + VAT* |
TOPRA MSc Students
|
£1,750.00 + 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.
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Terms and conditions
By booking a place on this course you are agreeing to the Training Terms and Conditions.