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

1-day training session

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About the training

Both Regulation (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.

 

REQUIRED LEVEL

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

F C

Florianne Torset-Bonfillou Compliance Director; Lead Auditor & Product Reviewer

Florianne is the Director of the Compliance Department at GMED North America. She has a background in Biology, Chemistry and Quality Management. After working in the Pharma/Device industry, Florianne first joint GMED as an Assessor. She is a Lead Auditor and a Product Reviewer with focus on high risk devices, mainly in the cardio and neurovascular field.

Florianne provides Regulatory support to the local team and is currently focusing on the transition to the European Regulation EU 2017/745 and EU 2017/746.

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

Day 1
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  • 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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