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