Training Features

EU IVDR 2017/746 Essentials: Understanding the Basics

Join us for this virtual training on 13 and 20 July 2026 to gain a solid foundation in the EU IVDR and confidently navigate its requirements for in vitro diagnostic devices.
Format

Virtual Training

Level

Basic

Date

13 and 20 July 2026

Time

14:00 - 17:00 CET

Duration

2 x 3 hours

Trainer

Kevin Kenney

Certificate

Certificate included

Price

€ 595 or equivalent currency

Introduction to the EU IVDR for In Vitro Diagnostic Devices

The IVDR introduces new and more stringent requirements for in vitro diagnostic medical devices, impacting manufacturers, authorized representatives, importers, and distributors. Understanding the key principles of the IVDR is essential for ensuring compliance and market access. 

Led by Kevin Kenney, this interactive training help professionals gain a solid foundation in the IVDR. This course covers the essential requirements, classification rules, conformity assessment procedures, and key obligations under the regulation. Participants will receive a certificate upon completion, detailing the learning objectives and confirming their understanding of the IVDR framework.
Training Overview
Agenda
Key Learning Objectives
What is included?
Training Dates
Who Should Attend?
Training Overview
The In Vitro Diagnostic Regulation (IVDR) introduces stricter requirements that affect manufacturers, authorized representatives, importers, and distributors. A thorough understanding of the IVDR is critical for ensuring regulatory compliance and maintaining market access.

This virtual training provides professionals with a solid foundation in the IVDR, covering essential requirements, device classification rules, conformity assessment procedures, and the key obligations imposed by the regulation. Participants will gain practical insights into meeting regulatory expectations and receive a certificate upon completion, confirming their understanding of the IVDR framework.
Key Learning Objectives
  • Understand the background and purpose of the IVDR, including key changes from the IVDD
  • Learn about the new classification system and how it impacts different IVD devices
  • Gain insight into the roles and responsibilities of manufacturers, authorized representatives, importers, and distributors under the IVDR
  • Understand the conformity assessment routes and the role of Notified Bodies
  • Learn about the essential requirements for technical documentation and performance evaluation
  • Understand how to implement and maintain an IVDR-compliant Quality Management System (QMS)
  • Gain knowledge on post-market surveillance (PMS) and vigilance requirements, including incident reporting and trend analysis
  • Learn how to ensure ongoing compliance with regulatory requirements throughout the device lifecycle
  • Understand the economic and legal implications of IVDR non-compliance.
What is included in this live virtual training?
  • Direct access to an expert trainer
  • Interactive and engaging training session
  • Access to the Qserve Learn Training Portal
  • A training certificate upon completion of the training.
Training Dates
This training is delivered in two sessions, lasting 3 hours each, providing a focused and efficient learning experience. The sessions will take place on 13 and 20 July 2026, allowing participants to absorb key information between training days while minimizing disruption to their daily work.

If this training date is not suitable, additional sessions will be held on 16 and 23 March, 20 and 27 April, and 12 and 19 October 2026. More information can be found on the registration pages.
Who Should Attend?
  • Regulatory Affairs professionals involved in IVD compliance
  • Quality Assurance managers and directors
  • Manufacturers, authorized representatives, importers, and distributors of IVD devices
  • Professionals responsible for technical documentation and conformity assessment
  • Individuals involved in post-market surveillance (PMS) and vigilance activities
  • Anyone seeking a foundational understanding of the IVDR and its impact on IVD regulations.
Customized Team Training
We offer fully tailored team training programs designed around your specific products, processes, technologies, and challenges, ideal for addressing unique training needs or accommodating larger groups. Learn More.
Topics Discussed in the Training
  • Regulatory framework and background, covering the IVDR, key differences from the IVDD, transition timelines, and the roles of Notified Bodies and authorities.
  • Scope and classification of IVD devices, including new classification rules, the risk-based approach, and practical examples
  • Conformity assessment and Notified Body involvement, outlining procedures, engagement moments, and the role of performance evaluation.
  • Responsibilities of economic operators, including duties of manufacturers, representatives, importers, and distributors, plus supply chain and post-market obligations.
  • Technical documentation and performance evaluation, including required elements, scientific validity and clinical evidence, and the importance of PMPF.
  • Quality management system requirements, focusing on IVDR-aligned QMS implementation, integration with ISO 13485, and ongoing monitoring.
  • Post-market surveillance and vigilance, covering PMS planning, incident reporting, trend analysis, and field safety actions.
  • Economic and legal considerations, including liability implications, market access strategies, and business risks related to non-compliance.

Flexible Online Training Designed for MedTech Professionals

Participate from anywhere with our interactive virtual format, designed to fit your schedule while delivering in-depth, actionable content tailored to real-world regulatory challenges.
Upon successful completion of the program, participants receive a recognized certification, boosting their career prospects and demonstrating their expertise to employers and clients.

Certification and Career Advancement

Learn directly from regulatory experts with practical industry experience and gain clear, actionable insights into navigating x.

Expert-Led Training for Practical Compliance

Meet the Trainer

Kevin Kenney

Kevin is a consultant at Qserve Group US Inc. with over 15 years of experience in the medical device industry, specializing in electromechanical design, safety compliance, and end-to-end product development from design to manufacturing.