IVDR (EU 2017/746) Overview Training | Online, Apr 16–17, 2026
ResearchAndMarkets has announced the addition of the “Introduction to the In-Vitro Diagnostic Regulation (IVDR) Training Course (April 16–17, 2026)” to its growing portfolio of professional development and regulatory training programs. This comprehensive two-day online course is designed to provide in-depth guidance on the European Union’s In-Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), which represents one of the most significant regulatory transformations the in-vitro diagnostics (IVD) industry has experienced in decades.
The IVDR, which entered into force in May 2017 and replaced the former In-Vitro Diagnostic Medical Devices Directive (98/79/EC), was introduced to strengthen the regulatory framework governing IVDs across the European Union. With an extended transition period, the Regulation introduces stricter oversight, enhanced requirements for clinical evidence, expanded responsibilities for economic operators, and a more robust system of conformity assessment involving Notified Bodies. These changes aim to improve patient safety, product performance, and transparency throughout the IVD lifecycle.
A New Regulatory Landscape for In-Vitro Diagnostics
Under the IVDR, manufacturers face a fundamentally different regulatory environment compared to the previous Directive. One of the most impactful changes is the introduction of a new risk-based classification system, derived from the Global Harmonization Task Force (GHTF) principles. For the first time, classification rules explicitly consider patient risk and public health impact, rather than relying primarily on product type.
As a result, it is estimated that approximately 80% of all IVDs will now require some level of conformity assessment by a Notified Body, compared with only around 20% under the former Directive. This shift significantly increases the regulatory burden on manufacturers, many of whom previously relied on self-declaration. Organizations across the supply chain—including manufacturers, authorized representatives, importers, and distributors—must now reassess their regulatory strategies, technical documentation, and quality management systems to remain compliant.
Course Objectives and Learning Outcomes
This training course has been specifically developed to help industry professionals understand and navigate the requirements of the IVDR. Over two days, participants will gain a structured and practical understanding of the Regulation, including how it differs from the IVDD, what new obligations apply, and how these changes impact product development, market access, and post-market activities.
The course will:
- Explain the legal and regulatory foundations of the IVDR
- Highlight the key differences between the IVDD and IVDR
- Clarify the roles and responsibilities of manufacturers and other economic operators
- Provide guidance on conformity assessment routes and Notified Body involvement
- Address technical documentation, performance evaluation, and clinical evidence requirements
- Explore post-market surveillance, vigilance, and risk management obligations
- Support participants in developing practical transition and compliance roadmaps
Interactive workshops are integrated throughout both days to reinforce learning, encourage discussion, and provide hands-on experience with real-world regulatory scenarios.
Day One: Foundations of IVD Regulation and IVDR Requirements
The first day of the course begins with a foundational introduction to in-vitro diagnostic devices, including their definition, scope, and unique regulatory considerations. Participants will examine why IVDs are regulated separately from medical devices and how international standards support regulatory compliance.
A historical overview of the In-Vitro Diagnostic Directive (98/79/EC) will provide essential context, including its structure, key provisions, and limitations. This sets the stage for understanding why regulatory reform was necessary and how the IVDR addresses gaps in the previous framework.
The course then transitions into a detailed introduction to IVDR (EU) 2017/746, covering:
- The drivers behind the transition from a Directive to a Regulation
- The scale and scope of regulatory change
- The structure of the Regulation and its annexes
- The expanded and evolving role of Notified Bodies
Participants will gain insight into how conformity assessment procedures have changed and what manufacturers must do to prepare for increased regulatory scrutiny.
Key IVDR topics explored on Day One include:
- Persons Responsible for Regulatory Compliance (PRRC): roles, qualifications, and responsibilities
- Economic Operators: obligations of manufacturers, importers, and distributors
- Unique Device Identification (UDI): implementation and traceability requirements
- Software as an IVD: regulatory considerations and classification challenges
- Intended Purpose and Intended Use: regulatory significance and documentation expectations
An interactive workshop will allow participants to apply these concepts in practice, particularly in defining intended purpose and assessing regulatory impact.
The day concludes with in-depth coverage of performance evaluation and clinical evidence, including how manufacturers must demonstrate scientific validity, analytical performance, and clinical performance under the IVDR. Participants will also explore the compilation of technical documentation, including the structure and content of the Summary Technical Documentation (STED), and understand the differences between technical files and design dossiers.
Labelling requirements, including electronic instructions for use (eIFUs), language and symbol usage, translation obligations, and EUDAMED traceability requirements, will also be addressed.
Day Two: Quality Systems, Risk, and Post-Market Obligations
Day Two focuses on the integration of the IVDR with quality management systems, risk management, and post-market requirements.
The day begins with an overview of ISO 13485:2016, including:
- Core principles and requirements
- Key changes from the 2012 edition
- Alignment with IVDD and IVDR expectations
Participants will explore how ISO 13485 supports regulatory compliance and how quality systems must be adapted to meet IVDR requirements.
Risk-based classification of IVDs is examined in detail, with participants learning how devices are classified under the new rules. A practical workshop on product classification will allow attendees to apply classification rules to example devices and discuss common challenges and pitfalls.
Risk management is then addressed from both a regulatory and standards-based perspective, including:
- IVDR risk management requirements
- Application of ISO 14971
- Usability considerations
A dedicated workshop will provide hands-on experience in risk management planning and documentation.
The course also covers clinical evidence and common specifications, clarifying the distinction between scientific validity and performance evaluation, and explaining how manufacturers can meet evidence expectations.
Post-market surveillance (PMS) and vigilance requirements under the IVDR are explored in depth, including:
- Incident reporting obligations
- Field Safety Corrective Actions (FSCA)
- Regulatory timelines and reporting processes
Case studies involving reporting and recalls will help participants understand real-world regulatory expectations.
The course concludes with a forward-looking discussion on key timelines, transitional provisions, and practical considerations. Participants will engage in a structured discussion on developing a roadmap for IVDR transition and long-term compliance.
Certifications and Target Audience
Participants who complete the course will receive:
- 12 CPD hours for professional development records
- A Certificate of Completion
The training is intended for a broad range of professionals involved in the IVD lifecycle, including:
- Regulatory affairs personnel
- Persons Responsible for Regulatory Compliance (PRRCs)
- Quality assurance and quality management professionals
- Individuals responsible for OEM and subcontractor oversight
- Economic operators, including importers and distributors
Expert Speaker
The course is led by Stuart Angell, Director of IVDeology Ltd, a recognized expert in medical device and in-vitro diagnostic regulatory affairs.
Mr. Angell has over 15 years of experience in the IVD industry and specializes in global regulatory strategy and compliance, with particular focus on the transition to the EU Medical Device and In-Vitro Diagnostic Regulations, MDSAP, and ISO 13485:2016. His background includes extensive work with self-declared and Annex II devices, as well as regulatory submissions across multiple global markets, including the European Union, the United States (FDA), Health Canada, the TGA, Russia, and Latin America.
He brings deep expertise in risk management, post-market surveillance, and vigilance, offering participants practical insights grounded in real-world regulatory experience.
About ResearchAndMarkets.com
ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
