IVD Regulation – (EU) 2017/746 for In Vitro Diagnostic Medical Devices

About the Course

The IVDR is the new regulatory basis for placing on the market, making available and putting into service in vitro diagnostic medical devices in the European market. It will replace the EU’s current Directive on in vitro diagnostic medical devices (98/79/EC). As a European regulation, it will be effective in all EU member states and EFTA states immediately without need to be transferred into the law of respective states, however national laws may be adapted to back up some requirements in more detail. 

YOUR BENEFITS

This course will help you to understand the requirements of EU IVD regulation 2017/746 for In Vitro Diagnostic medical devices while fulfilling the regulatory compliance, mandatorily to place the IVD device in European market.

COURSE CONTENT / OUTLINE

Day 01

Overview of EU IVD Regulation

• IVD Regulation – Introduction
• Requirements of Economic Operators
• Classification – Classification Rules
• Conformity Assessment Procedures
• Technical documentation
• Requirements of performance evaluations
• Requirements regarding Traceability (UDI / EUDAMED)
• Post-Market Surveillance (9PMS), Vigilance and Market Surveillance

Day 02

Requirements of Technical Documentation

• Introduction & Definitions
• Elements of Technical Documentation
• Device description and specifications
• Labels & Instructions for use
• Design and manufacturing information
• General Safety Performance Requirements
• Benefit Risk Analysis and Risk Management
• Product verification and validation
• Summary of safety & performance
• Post market surveillance plan
• EU declaration of conformity
• Post market surveillance

WHO SHOULD ATTEND

Manufacturers of medical devices, especially: Regulatory Affairs, Design and Development, Clinical Affairs Specialists, Quality Management, and Quality Assurance personnel. 

TRAINING DURATION

02 days

PRE-REQUISITES

Preferred to have basic knowledge of ISO 9001 & ISO 13485 Standards and / or experience if medical device operations.

EXAM DETAILS

Participants will be assessed through the course for punctuality, interactive approach, involvement in workshop in the course and finally through a written examination at the end of the course. Participants successfully completing the course will receive a course completion certificate.

CERTIFICATION

All Participants who have completed both the days of training will be issued with a certificate of attendance from TÜV SÜD South Asia.