Training: Introduction to EU Regulatory Pathways – For US Companies

Speaker: Paige Sutton-Smith
Duration: 2 hours
Date: October 21st 2025, Online
9:00 AM – 11:00 PM US Eastern Daylight Time (EDT)
3:00 PM – 5:00 PM Central European Summer Time (CEST)

• Training Objectives

  This training will introduce the different EU regulatory pathways for medical devices under the Medical Devices Regulation (MDR) 2017/745, give an overview of the classification process for medical devices under MDR, and discuss the requirements and timelines for each pathway. This training is aimed at anyone involved in design and development or regulatory activities, and especially tailored towards those already familiar with the US FDA process of device classification.

• Training Content

  • CE marking process under EU MDR
  • The role of the Notified Body
  • Quality Management System certification
  • EU MDR classification rules
  • EU Authorized Representative

• Training Format

  • Presentations with interactive discussions
  • Group and individual exercises
  • End of training assessment

• Target Audience

  • R&D, Engineering, and Design and Development professionals
  • Quality and Regulatory professionals
  • Start-up companies looking to understand EU marketing options
  • Medical device professionals in the US looking to expand to the EU market

• Price

  EUR 215, including course material and certificate