North America’s Training Center

European in Vitro Diagnostic Devices Regulation (EU) 2017/746

2-day training session

About the training

The European Regulations on In Vitro Diagnostic Devices– IVDR EU 2017/746 – entered into force on May 26th, 2017. GMED North America has designed a comprehensive training course to help companies get ready for their application to obtain and/or maintain CE marking for their in vitro diagnostic device product(s) and:

Gain an understanding of the changes introduced by European In Vitro Diagnostic Device Regulation – IVDR EU 2017/746;
Assess the impacts of those changes on their organizational and structural activities.

REQUIRED LEVEL

Good knowledge and effective practice of the Directives 98/79/EC.

Haijuan Li, PhD, MBA, RAC (US) Product Reviewer and Lead Auditor, GMED North America

Dr. Haijuan (Jane) Li is an accomplished IVD expert in both product development and worldwide regulatory compliance implementation in clinical diagnostics. Jane has 20 years of R&D experience in senior management and technical roles at several well-known diagnostics companies including Roche Diagnostics, Bio-Rad Laboratories, Siemens Healthcare Diagnostics and Thermo Fisher Scientific and 5 years of experience at notified bodies as lead auditor and product reviewer. Jane has designed, developed and launched many IVD and companion diagnostics devices in the US, EU and worldwide.

Jane is currently a product reviewer and lead auditor for IVD devices at GMED North America. Jane holds a Ph.D. in Biochemistry from Rutgers University (New Jersey, USA) and an MBA from Anderson University (Indiana, USA). Jane has been earned the RAC (US) certification since 2013.

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

Identify the major changes between the Directive and Regulation
Understand the structure of the Regulation
Understand the new requirements of the Regulation

Educational Resources

Presentations
Practical working sessions
Course evaluation

Check out the Program

Day 1 & 2

Program

Regulation structure
Scope and Definitions
Actors and Responsibilities
Device Classification Criteria
General safety and performance requirements
Conformity Assessment routes
UDI
Performance evaluation
Method of proof
Specific procedure
Post Market Surveillance
Requirements for the Vigilance system
Eudamed
Transitional arrangements
Practical working sessions
Group workshop
Course Evaluation
Summary and Discussion with the trainer

Attendees Testimonials

The trainer is very knowledgeable and was able to make comparison with the IVD 98/79/CE and the FDA regulations. The training pace was good. The presentation of the 2017/746 regulation was very clear and gives an accurate overall of it.

Sr. Regulatory Affairs Specialist

All-important requirements of the IVDR are well explained and some examples are given to better understand.

Regulatory Affairs Specialist

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