This course is also available to attend online.
When: 2-4 June 2026
Where: Dublin, Ireland
Day 1 start time: 10:15 BST (CET+1) | Day 3 end time: 16:15 BST (CET+1)
CPD: 20 CPD hours upon successful completion
Who should attend
This course is ideal for:
- Professionals new to medical devices and in vitro diagnostics (IVDs), typically 1-2 years’ experience
- Those seeking a broader understanding of medical device regulation
- Medicines regulatory professionals working with drug-device combination products
- Regulatory affairs professionals looking to transition into or deepen their knowledge of medical devices
- Students of the TOPRA MSc programme
What you'll learn
By completing this course, you will be able to:
- Navigate EU and UK medical device regulations with confidence
- Classify medical devices and assess borderlines issues
- Select and implement the right conformity assessment route
- Establish and maintain an internal audit and supplier audit programme
- Apply essential requirements, standards, and risk management principles
- Plan clinical evidence and post-market surveillance strategies
- Manage audits, vigilance, and Field Safety Corrective Actions (FSCA)
- Recognise diverse country requirements
- Assess regulatory impact of marketing materials and documentation
Course overview
Strategic insight into the EU and UK regulatory landscape is essential for navigating medical device development and market access. This course focuses on the practical application of current legislation, including the Medical Device Regulation (MDR) and UKCA marking, to ensure compliance and support product success. Participants will examine key regulatory concepts such as classification, conformity assessment, clinical evaluation, and post-market surveillance. Through interactive, discussion-led sessions, they will build the confidence to apply regulatory principles in real-world contexts.
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 all attendees, regardless of your country of origin. 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.