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Post Market Surveillance and Vigilance New Requirements under the European Medical Device Regulations

8-hour training session


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Next Training Date Jun 28, 2023 , Training | Virtual Classroom

About the training

Both Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) include new and more detailed Post-market surveillance and vigilance requirements.

The transitional provisions described in both Regulations (MDR Article 120, IVDR Article 110), require a manufacturer to implement the Post-market surveillance, market surveillance, vigilance requirements during the transitional period in order to keep placing its Device on the market with a Medical Device Directive certificate after the date of the Regulations application. For the Regulation (EU) 2017/745, it is starting May 27, 2021; for the Regulation (EU) 2017/746, May 27, 2022.

This course has been designed to allow manufacturers to easily identify the key requirements and prepare for their timely implementation.



Basic knowledge of the post-market requirements under the Directives 93/42/EEC, 90/385/EEC and 98/79/EC


Florianne Torset-Bonfillou Compliance Director; Lead Auditor & Product Reviewer, GMED North America

Florianne is a Senior International Project Manager at GMED North America. She is also a Lead Auditor and a Product Reviewer with focus on high-risk devices, mainly in the cardio and neurovascular field.

She has a background in Biology, Chemistry and Quality Management. After working in the Pharma/Device industry, Florianne first joint GMED as an Assessor, then became part of the Quality & Regulatory support team. For the past 5 years, Florianne provided Regulatory support to the local team for the transition to the European Regulation EU 2017/745 and EU 2017/746. Since 2023, she supports the UK subsidiary towards its UKCA designation.

She is also a trainer on the European Regulation, Quality Management, Risk Management, and other regulatory and quality topics.

Who Should Attend

  • Medical Device Manufacturers: Regulatory Affairs Managers, Quality Managers, Person in Charge of Regulatory Compliance
  • Internal and External Auditors
  • Importers
  • Distributors

Learning Objectives

  • Identify regulatory requirements with regards to Post Market Surveillance and Vigilance
  • Implement new Post-Market Surveillance and Vigilance requirements under Regulations (UE) 2017/745 and (UE) 2017/746
  • Identify tools and forms to be used, methods to implement

Educational Resources

  • Presentations
  • Practical working sessions
  • Course evaluation

Check out the Program

  • Post Market Surveillance and Vigilance requirements
  • Analysis of new requirements
  • EUDAMED Vigilance module
  • Transitional provisions – Notified Body’s expectations
  • Implementation: PMS plan, PSUR, PMCF… (tools, forms, methods)
  • Role of the Notified Body – new activities
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