This course is also available to attend in person.
When: 26-28 January 2027
Where: Online
Day 1 start time: TBC | Day 3 end time: TBC
CPD: 19 hours upon successful completion
Who should attend
This course is ideal for:
- Delegates from the regulatory affairs industry who wish to develop their knowledge of the post-market surveillance and vigilance for medical devices
- Delegates 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:
- Interpret and apply European PMS and vigilance requirements and supporting guidance
- Understand the roles and responsibilities of manufacturers, notified bodies, competent authorities and other economic operators
- Develop and tailor PMS plans and processes for different device types, including IVDs and drug–device combinations
- Integrate PMS data into quality and regulatory activities such as risk management and clinical evaluation
- Use electronic PMS and vigilance systems, including EUDAMED and international databases
- Prepare and assess PMS and vigilance outputs, including PMS reports, PSURs and trend reports
- Recognise additional global requirements, including US MDRs, and the role of the PRRC in PMS compliance
Course overview
Vigilance and post-market surveillance (PMS) play a vital role in maintaining the safety and performance of medical devices after they reach the market. This course explores how PMS systems are integrated into the product lifecycle and aligned with evolving European regulatory requirements. Key topics include the roles and responsibilities of manufacturers, notified bodies, and competent authorities; proactive PMS planning and reporting; vigilance systems and the use of electronic tools for data collection and communication. Participants will develop the ability to critically assess and apply these processes in practice.
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.