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

About the speaker:
Paige is a quality management and regulatory professional with 13 years in the medical device industry. Her expertise includes regulatory strategy, product design and development, process validations, V&V, QMS deployment, and auditing to FDA 21 CFR 820 / ISO 13485. She is experienced with complex invasive and implantable devices. Paige assists clients with product design and development of Class II and Class III medical devices, including regulatory submissions and complex process control and supplier strategies. She holds a RAC (Regulatory Affairs Certification) – Devices and is a Certified Quality Engineer and Certified Six Sigma Black Belt.

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

Training certificate:
Participants will receive a certificate upon successful completion of the end of training assessment.

Who should attend:
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 incl. course material and certificate