Awareness Training Program on IVD Regulation – (EU) 2017/746 for In Vitro Diagnostic Medical Devices

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 the need to be transferred into the law of respective states.

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

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

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

• 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
  
• Get an overview of EU IVD Regulation
• Understand the Post-Market Surveillance (9PMS), Vigilance and Market Surveillance
• Understand the benefits of Risk Analysis and Risk Management

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.

1. When can I get the certificate?

IVD Regulation – (EU) 2017/746 For in VITRO Diagnostic Medical Devices certification will be issued within 21 working days from the examination date.

2. When can I get the training material and invite?

One day before the commencement of the training program.

3. How do I pay the fees for training and examination?

Online mode

4. What are the benefits of the IVD Regulation – (EU) 2017/746 For IN VITRO Diagnostic Medical Devices Program?

• 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
• Get an overview of EU IVD Regulation
• Understand the Post-Market Surveillance (9PMS), Vigilance and Market Surveillance
• Understand the benefits of Risk Analysis and Risk Management

5. Is there any refund policy for the paid fees?

Please refer to Cancellation and Refund policy page.