European Medical Devices Regulation (EU) 2017/745

The European Regulations on Medical Devices (including Active Implantable Medical Devices AIMD) – MDR EU 2017/745 – was published on May 5th, 2017 and entered into force on May 25th, 2017. With May 26th, 2021 as its application date, there is not a lot of time left for Medical Device companies to get up to speed. GMED North America has designed a comprehensive training course to help companies prepare for their application to obtain and/or maintain CE marking for their medical device product(s) and:

• Gain an understanding of the changes introduced by both European Medical Device Regulation – MDR EU 2017/745;
• Assess the impacts of those changes on their organizational and structural activities.

REQUIRED LEVEL

Good knowledge and effective practice of the Directives 93/42/EEC or/and 90/385/EEC.

Who Should Attend

• Medical Device Manufacturers: Senior Management , Regulatory Affairs Managers and Quality Managers, R&D specialists, Development, Manufacturing and Marketing Managers
• Internal and external Auditors
• Importers
• Distributors

Learning Objectives

• Address the new Quality Management System (QMS) requirements
• Understand the Product Classification criteria’s and Conformity Assessment routes and how it applies to their device(s)
• Assess the impacts on the Technical Documentation for Medical Devices in relation with Product Classification criteria’s
• Identify the expectations with respect to the Clinical Evaluation, Clinical Data(s) and Risk Management
• Implement the requirements for labelling, the Unique Device Identification (UDI) and EUDAMED
• Address the expectations with respect to the requirements pertaining to the Post market Surveillance and Vigilance reporting (Periodic reports etc.)

Educational Resources

• Presentations
• Practical working sessions
• Course evaluation

Program

• Regulation structure
• Scope and Definitions
• Actors and Responsibilities
• Device Classification Criteria
• Conformity Assessment routes
• Quality Management System requirements
• Technical Documentation
• Post Market Surveillance and Vigilance reporting requirements
• The Transition
• Practical working sessions
• Group workshop
• Course Evaluation
• Summary and Discussion with the trainer

About the Trainer

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.

Host or Publisher GMED North America, Inc.