Training Features

EU IVDR 2017/746: Basics for Non-Regulatory Staff at In-Vitro Diagnostics Manufacturers

Learn how IVDR affects your role and help your company maintain compliance with this practical training for non-regulatory staff.
Format

Virtual Training

Level

Basic

Date

20 January 2026

Time

15:00 - 17:00 CET

Duration

2 hours

Trainer

Gert Bos

Certificate

Certificate included

Price

€ 295 or equivalent currency

IVDR Training for Non-Regulatory Staff

The In Vitro Diagnostic Regulation (IVDR) 2017/746 introduces stricter requirements for in vitro diagnostic (IVD) devices, impacting all departments within an IVD company, not just regulatory teams. A basic understanding of IVDR is essential for ensuring company-wide compliance and avoiding regulatory pitfalls. 

Led by Gert Bos, this interactive training help non-regulatory staff to understand how the IVDR affects their roles. This course covers the key principles, impact on daily operations, and essential compliance aspects in a clear and practical manner. Participants will receive a certificate upon completion, confirming their understanding of IVDR fundamentals.

Training Overview
Agenda
Key Learning Objectives
What is included?
Training Dates
Who Should Attend?
Training Overview
The In Vitro Diagnostic Regulation (IVDR) 2017/746 introduces stricter requirements for IVD devices and affects all departments within an IVD company—not just regulatory teams. Understanding IVDR basics is essential to ensure company-wide compliance and avoid regulatory pitfalls.

This training is designed for non-regulatory staff and provides a practical overview of how IVDR impacts daily operations, from device classification and CE marking to post-market surveillance and departmental responsibilities. Participants will gain actionable insights into supporting compliance in their roles and will receive a certificate confirming their understanding of IVDR fundamentals.
Key Learning Objectives
  • Understand the purpose and impact of the IVDR on IVD manufacturers.
  • Learn how different company departments are affected by IVDR requirements.
  • Gain basic knowledge of device classification, CE marking, and conformity assessment.
  • Understand the importance of technical documentation and performance evaluation data.
  • Learn how marketing, sales, manufacturing, and other non-regulatory teams contribute to compliance.
  • Recognize key regulatory terms and processes to improve cross-department collaboration.
  • Identify best practices for supporting IVDR compliance in your daily work.
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 one session, lasting 2 hours, providing a focused and efficient learning experience. The sessions will take place on 20 January 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 in 2026. More information will be shared soon.
Who Should Attend?
  • R&D engineers and product development teams.
  • Manufacturing, supply chain, and operations staff.
  • Sales, marketing, and commercial teams.
  • Customer service and complaints-handling professionals.
  • Quality Assurance (QA) professionals new to IVDR.
  • Anyone working at an IVD company who needs a foundational understanding of IVDR compliance.
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 & Why It Matters: Overview of IVDR and key differences from IVDD, importance of compliance for all departments, and how regulatory requirements impact company operations.
  • Key IVDR Requirements & Their Impact on Daily Work: Device classification, CE marking and product certification, and the role of Notified Bodies and Competent Authorities.
  • How Different Departments Are Affected by IVDR: R&D & Engineering (performance evaluation, risk management, usability), Manufacturing & Supply Chain (supplier requirements, traceability), Sales & Marketing (advertising, labeling, promotional restrictions), and Customer Service & Complaints Handling (post-market surveillance, incident reporting).
  • Technical Documentation & Product Compliance: Contents and purpose of technical documentation, impact of performance evaluation and scientific validity on product approval, and basics of post-market surveillance and vigilance reporting. 
  • How to Support Compliance in Your Role: Recognizing IVDR-related tasks in daily work, communicating effectively with the regulatory team, and avoiding common mistakes that lead 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

Gert Bos

Gert has 26 years of experience in life sciences (devices and pharma), in university, industry, 4 Notified Bodies, and in strategic regulatory and business consulting.
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