Essentials of European Medical Device Regulatory Affairs

Essentials of European Medical Device Regulatory Affairs
Gain a practical introduction to European medical device regulations and the regulatory affairs profession. Explore key requirements including CE marking, device classification, conformity assessment and post-market surveillance, enabling you to support compliance with confidence.






When: 6 April 2027
Where: Online
Time: 09:30-17:00 BST
CPD: 6 CPD hours upon successful completion

Who should attend

This course is ideal for:

  • Those who are new to regulatory affairs profession in the medical devices industry
  • Those who wish to move into the profession
  • Those working in related professions (law, pharmaceutical manufacturing, marketing and sales, healthcare, administration, project management)
  • Those currently working in regulatory authorities and those in the regulatory sector

What you'll learn

By completing this course, you will be able to:

  • Understand European medical device regulations, including CE marking, device classification, and conformity assessment
  • Learn how to ensure compliance with obligations for economic operators, post-market surveillance, and technical documentation
  • Develop a broad perspective on the regulatory affairs profession and its role in the medical devices industry

  • Build a professional network to support your career growth in regulatory affairs

Course overview

This one-day course offers a practical introduction to European medical device regulations. Designed for those starting their career in regulatory affairs, this training equips you with the essential knowledge and skills to navigate compliance, support product development, and advance confidently in the medical devices industry.

Course presenters

Pricing

TOPRA member: £650 + VAT
Non-member: £910 + VAT

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Members working for regulatory or government agencies, academic institutions, charities, patient groups, emerging markets and MSEs can access further discounted rates. Please email meetings@topra.org before booking.

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Terms and conditions

By booking a place on this course you are agreeing to the Training Terms and Conditions.

 
When
06/04/2027
Where
Online
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