IVDR Fundamentals Training – Comprehensive Course to understand IVDR Requirements

This training is intended for professionals involved in:

• Regulatory Affairs
• Quality Management
• Product Compliance
• Clinical and Performance Evaluation
• Product Development and R&D
• Manufacturing and Operations
• Software and Digital Health Development
• PRRC (Person Responsible for Regulatory Compliance) functions
• Authorized Representatives
• Importers and Distributors
• Diagnostic Service Providers
• Project Managers and Decision Makers
• Individuals transitioning from IVDD to IVDR

Module 1: Introduction to IVDR

• Regulatory background
• Transition from IVDD to IVDR
• Scope and definitions
• Key regulatory changes
• Transition provisions

Module 2: Economic Operators

• Manufacturers
• Authorized Representatives
• Importers and Distributors
• PRRC requirements
• Registration obligations

Module 3: Classification

• Risk-based classification framework
• Classes A, B, C and D
• Software classification
• Self-testing and near-patient testing
• Modern software classification scenarios

Module 4: Conformity Assessment

• Conformity assessment pathways
• Notified Body involvement
• EU Reference Laboratories
• Companion diagnostics

Module 5: Technical Documentation

• Annex II and Annex III
• GSPR requirements
• Risk management
• Labeling and IFU
• Declaration of Conformity

Module 6: Performance Evaluation

• Scientific validity
• Analytical performance
• Clinical performance
• PEP and PER
• PMPF
• Clinical performance studies

Module 7: Traceability and Registration

• UDI
• Basic UDI-DI
• SRN
• EUDAMED
• Current EUDAMED implementation developments

Module 8: PMS and Vigilance

• PMS plans and reports
• Trend reporting
• Vigilance
• PSUR
• Article 10a supply interruption requirements

Module 9: AI and Emerging Technologies

• Software as an IVD
• AI-enabled diagnostics
• AI and the IVDR
• Emerging technology considerations
• Digital pathology
• Genomic diagnostics
• Companion diagnostics
• Point-of-care testing innovations

Module 10: Practical Exercises and Case Studies

• Economic operator exercises
• Classification exercises
• Software-based IVD case studies
• Performance evaluation scenarios
• PMPF exercises
• IVDR transition planning discussions

The In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) introduced a significantly enhanced regulatory framework for in vitro diagnostic medical devices (IVDs) within the European Union. Compared to the previous IVDD framework, IVDR introduces a risk-based classification system, expanded Notified Body involvement, strengthened technical documentation requirements, enhanced performance evaluation expectations, and more robust post-market obligations.

This comprehensive training provides participants with a structured understanding of IVDR requirements throughout the entire product lifecycle. The course explains the regulatory framework, transitional provisions, roles and responsibilities of economic operators, classification principles, conformity assessment pathways, technical documentation requirements, General Safety and Performance Requirements (GSPR), and performance evaluation expectations.

Participants will gain practical knowledge of scientific validity, analytical performance, clinical performance, Performance Evaluation Plans (PEP), Performance Evaluation Reports (PER), Post-Market Performance Follow-Up (PMPF), clinical performance studies, UDI requirements, Basic UDI-DI, EUDAMED, PMS, vigilance, trend reporting, and Periodic Safety Update Reports (PSUR).

In addition to regulatory fundamentals, the course addresses current implementation developments, including EUDAMED rollout requirements, supply interruption obligations under Article 10a, modern software-based IVDs, AI-enabled diagnostic technologies, and the evolving regulatory expectations surrounding artificial intelligence and digital health solutions used within the diagnostic sector.

Practical exercises, real-world case studies, and interactive discussions help participants apply IVDR requirements to realistic business scenarios, enabling them to better understand the impact of IVDR on products, projects, processes, and organizational compliance activities.

By the end of this course, you will be able to:

1. Explain the purpose, structure, and scope of the IVDR.
2. Identify the key differences between IVDD and IVDR.
3. Apply IVDR classification rules and determine appropriate conformity assessment pathways.
4. Understand technical documentation and performance evaluation requirements.
5. Describe the obligations of manufacturers and other economic operators.
6. Explain traceability, UDI, EUDAMED, PMS, and vigilance requirements.
7. Recognize current regulatory trends affecting software-based and AI-enabled IVDs.

Upon successful completion of this course, you will be able to:

• Understand the structure, scope, and key requirements of Regulation (EU) 2017/746 (IVDR).
• Interpret and apply IVDR classification rules, including software-based IVDs.
• Understand economic operator obligations and regulatory responsibilities.
• Navigate conformity assessment procedures and Notified Body involvement.
• Understand technical documentation, GSPR, and performance evaluation requirements.
• Apply post-market surveillance, vigilance, traceability, UDI, and EUDAMED requirements.
• Recognize emerging regulatory considerations related to AI-enabled diagnostics, digital health technologies, and modern IVD solutions.

The methodology emphasizes practical application of IVDR requirements to realistic regulatory and business situations.

Duration: 2 Days
Learning Mode: Online, Instructor-Led in a virtual classroom
Group Exercises: Yes
Exam: Yes
Certificate: Yes

This instructor-led virtual classroom training combines theory and practical application through:

• Interactive lectures
• Real-world regulatory examples
• Case studies
• Structured group exercises
• Knowledge checks and discussions
• Practical application activities
• Q&A sessions with the instructor
• Online examination

Participants interact directly with the instructor and fellow attendees throughout the training to enhance learning and knowledge sharing.

Participants will be assessed through:

• Interactive group exercises and practical case studies
• Knowledge checks and classroom discussions
• Instructor-led activities throughout the course
• Final online examination

Participants who attend at least 90% of the total training duration will receive an official Certificate of Attendance from TÜV SÜD Academy. And upon successfully passing the respective exam: participants will earn a certificate with the recognized title of “IVDR Specialist”.

Participants will receive:

• Comprehensive digital course workbook
• Training presentation materials
• Practical exercises and worksheets
• Case study materials
• Examination access and instructions
• Certificate of Attendance or IVDR Specialist Certificate (upon successful completion)

There are no formal prerequisites.

The training is suitable for:

• Individuals new to the IVD industry.
• Professionals seeking foundational IVDR knowledge.
• Personnel transitioning from IVDD to IVDR.
• Experienced regulatory and quality professionals requiring an IVDR update.

Basic familiarity with medical devices or the IVD industry is beneficial but not required.

What is the IVDR and why is it important?

The In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746, commonly referred to as the IVDR, is the European regulatory framework governing the placing on the market, making available, and putting into service of in vitro diagnostic medical devices (IVDs) and their accessories within the European Economic Area (EEA).

The IVDR replaced the former In Vitro Diagnostic Medical Devices Directive (98/79/EC - IVDD) and introduced significantly more rigorous requirements related to device classification, conformity assessment, clinical evidence, technical documentation, traceability, and post-market surveillance.

For manufacturers, authorized representatives, importers, distributors, and other stakeholders, compliance with the IVDR is essential to obtain and maintain CE marking and access the European market.

Since when does the IVDR apply?

The IVDR entered into force on 25 May 2017 and became fully applicable on 26 May 2022.

While certain transitional provisions apply to qualifying legacy devices, all manufacturers must ultimately comply with the IVDR requirements to continue marketing their IVD devices in the European market.

What are in vitro diagnostic medical devices (IVDs)?

In vitro diagnostic medical devices (IVDs) are medical devices used to examine specimens derived from the human body—such as blood, urine, tissue, or saliva—to provide information about a person’s health, disease status, physiological condition, or treatment response.

IVDs include a wide range of products, such as:

• Reagents
• Calibrators
• Control materials
• Test kits
• Instruments and analyzers
• Software
• Diagnostic systems
• Specimen receptacles

Examples include pregnancy tests, blood glucose monitors, infectious disease tests, blood typing assays, genetic tests, and cancer screening diagnostics.

Veterinary diagnostic products are not covered by the IVDR.

How do IVDs differ from other medical devices?

While IVDs are considered a category of medical devices, they differ from traditional medical devices because they are generally used to analyze samples taken from the human body rather than being used directly on the patient.

Examples of medical devices include surgical instruments, catheters, infusion pumps, wheelchairs, implants, medical imaging equipment, and medical apps. Due to their unique nature and public health impact, IVDs are regulated under a dedicated legal framework—the IVDR.

What are the main changes introduced by the IVDR?

The IVDR builds upon the principles of the former IVDD but introduces several significant changes, including:

• A new risk-based classification system (Classes A, B, C, and D)
• Expanded scope of regulated products
• Increased involvement of Notified Bodies
• More stringent requirements for manufacturers and other economic operators
• Enhanced technical documentation requirements
• Stronger clinical evidence and performance evaluation requirements
• Increased transparency through UDI and EUDAMED
• More rigorous post-market surveillance and vigilance obligations
• Greater focus on traceability throughout the supply chain

Importantly, most devices require reassessment under the IVDR, as previous certifications issued under the IVDD are not automatically grandfathered.

Who are economic operators under the IVDR?

The IVDR defines the following entities as economic operators:

• Manufacturers
• Authorized Representatives
• Importers
• Distributors

Each economic operator has clearly defined responsibilities and obligations regarding compliance, traceability, documentation, reporting, and communication throughout the supply chain.

The IVDR also introduced the role of the Person Responsible for Regulatory Compliance (PRRC), which manufacturers and authorized representatives must designate in accordance with Article 15.

Who else must comply with the IVDR?

In addition to economic operators, the IVDR may apply to:

• Health institutions manufacturing and using in-house IVD devices
• Laboratories operating under the in-house exemption
• Diagnostic service providers offering services to patients within the European Union
• Organizations conducting clinical performance studies involving IVDs

Certain provisions and exemptions may apply depending on the nature of the activities performed.

Who should attend this training?

This course is designed for professionals involved in the development, manufacture, regulation, quality management, distribution, and compliance of IVDs, including:

• Regulatory Affairs professionals
• Quality Management professionals
• PRRCs
• Product Compliance specialists
• R&D personnel
• Manufacturing and Operations teams
• Authorized Representatives
• Importers and Distributors
• IVD Consultants
• Diagnostic Service Providers
• Project Managers and Decision Makers

The course is suitable for both organizations located within the EU and companies outside the EU seeking access to the European market.

Is prior knowledge required?

No prior IVDR knowledge is required.

The course is suitable for:

• New employees entering the IVD industry
• Individuals seeking a foundational understanding of IVDR requirements
• Experienced regulatory professionals transitioning from IVDD to IVDR
• Quality and compliance professionals looking to strengthen their understanding of current European regulatory requirements

Is this course suitable for beginners?

Yes. The course provides a comprehensive introduction to IVDR requirements and is appropriate for participants with little or no previous regulatory experience. It is equally valuable for experienced professionals seeking an update on regulatory developments and best practices.

What topics are covered during the training?

The course covers the full regulatory lifecycle of IVD compliance under Regulation (EU) 2017/746, including:

• IVDR fundamentals and regulatory framework
• Economic operator obligations
• Classification rules and risk classes
• Conformity assessment procedures
• Technical documentation requirements
• General Safety and Performance Requirements (GSPR)
• Performance evaluation and clinical evidence
• UDI and EUDAMED requirements
• Post-Market Surveillance (PMS)
• Vigilance and market surveillance
• Current transition provisions and regulatory developments

Does the course explain IVDR classification rules?

Yes. Participants will gain a detailed understanding of the IVDR risk-based classification system, including Classes A, B, C, and D, classification rules, software classification considerations, and practical classification examples.

Does the course cover conformity assessment procedures?

Yes. The course explains the conformity assessment pathways applicable under the IVDR, including the role of Notified Bodies, conformity assessment routes, technical documentation review, and class-specific requirements.

Does the course cover Technical Documentation requirements?

Yes. A dedicated section focuses on Technical Documentation requirements under Annex II and Annex III, including:

• Device description and specifications
• Labeling and Instructions for Use (IFU)
• Design and manufacturing information
• General Safety and Performance Requirements (GSPR)
• Risk Management documentation
• Product verification and validation
• Summary of Safety and Performance (SSP)

Does the course cover Performance Evaluation requirements?

Yes. The training provides an overview of the Performance Evaluation framework, including:

• Scientific Validity
• Analytical Performance
• Clinical Performance
• Performance Evaluation Plan (PEP)
• Performance Evaluation Report (PER)
• Post-Market Performance Follow-Up (PMPF)
• Clinical Performance Studies

Does the course cover UDI and EUDAMED?

Yes. Participants will learn about:

• Unique Device Identification (UDI)
• Basic UDI-DI
• UDI-DI and UDI-PI
• Single Registration Number (SRN)
• Device registration requirements
• EUDAMED modules and functionality
• Traceability obligations under the IVDR

Is Post-Market Surveillance (PMS) covered?

Yes. The course includes comprehensive coverage of:

• PMS systems and planning
• PMS Reports
• Periodic Safety Update Reports (PSUR)
• Vigilance reporting requirements
• Trend reporting
• Corrective and preventive actions
• Market surveillance obligations

Will I learn about the responsibilities of manufacturers and other economic operators?

Yes. The course reviews the responsibilities of all major economic operators, including:

• Manufacturers
• Authorized Representatives
• Importers
• Distributors
• Person Responsible for Regulatory Compliance (PRRC)

Participants will learn how these roles interact and what obligations each entity must fulfill under the IVDR.

Are practical exercises included?

Yes. The training includes interactive case studies and group exercises covering topics such as:

• Economic operator responsibilities
• Device classification
• Performance evaluation
• Regulatory decision-making

These activities help participants apply regulatory concepts in realistic scenarios.

Is an examination included?

Yes. The training concludes with an online examination designed to assess participants' understanding of the key concepts covered during the course.

Will I receive a certificate?

Participants who attend at least the required percentage of the training will receive a Certificate of Attendance.

Participants who successfully pass the examination will receive a certificate recognizing them as an IVDR Specialist.

What is the course duration and delivery format?

The course is delivered over two days as a live online instructor-led training.

Participants attend virtual classroom sessions led by an experienced instructor and engage in interactive discussions, exercises, and learning activities.

How can this course support an IVDR transition project?

This training helps organizations understand the regulatory and operational impacts of the IVDR by providing a structured overview of the requirements affecting product classification, conformity assessment, technical documentation, performance evaluation, traceability, and post-market activities.

Participants gain the foundational knowledge needed to support compliance initiatives and contribute effectively to IVDR implementation projects within their organizations.

Does the course cover software-based IVDs?

Yes. The course explains the classification and regulatory considerations applicable to software-based IVDs and includes practical software classification exercises.

Does the course cover artificial intelligence (AI) in diagnostics?

Yes. Participants are introduced to AI-enabled IVDs, machine-learning diagnostic tools, digital pathology applications, and current regulatory considerations related to AI-enabled medical technologies.

Does the course explain the relationship between IVDR and the EU AI Act?

Yes. The course provides an overview of emerging regulatory expectations affecting AI-enabled diagnostic systems and discusses the interaction between IVDR requirements and AI-related regulatory frameworks.

Does the course include practical case studies?

Yes. The course includes real-world exercises covering classification, economic operator responsibilities, performance evaluation, software-based IVDs, post-market activities, and regulatory decision-making.

Does the course discuss current EUDAMED implementation requirements?

Yes. Participants will learn about UDI, SRN, EUDAMED modules, traceability requirements, and recent EUDAMED implementation developments.

Does the course cover Article 10a supply interruption requirements?

Yes. The course introduces Article 10a requirements related to interruption or discontinuation of supply and discusses manufacturer obligations and regulatory expectations.

Will I learn about emerging diagnostic technologies?

Yes. The course introduces current industry trends including AI-supported diagnostics, digital pathology, next-generation sequencing (NGS), companion diagnostics, point-of-care testing, and software-driven diagnostic solutions.

Is this training suitable for professionals transitioning from IVDD to IVDR?

Yes. The training is specifically designed to help professionals understand the regulatory changes introduced by IVDR and the practical implications for products, processes, and organizations.

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