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In Vitro Diagnostic Regulation (IVDR): Regulation (EU) 2017/746

IVDR TRAINING COURSE INFORMATION

£129
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Build a practical understanding of the EU requirements for in vitro diagnostic medical devices and their application to clinical research.

Developed by experienced clinical research professionals, this online IVDR training course explains the key requirements of Regulation (EU) 2017/746, from device classification and performance evaluation to performance studies and post-market responsibilities.

The course is suitable for individual professionals and organisations looking to provide consistent IVDR training across their clinical, regulatory and quality teams.

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Price

£129.00

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KEY FEATURES OF OUR ONLINE IVDR TRAINING COURSE:

  • Fully online, with learning available whenever you need it
  • Self-paced study that fits around your working day
  • Developed by clinical research experts with more than 35 years of experience
  • Covers the IVDR requirements relevant to IVD studies and clinical research
  • Practical scenarios, case studies and interactive knowledge checks
  • Certificate provided following successful course completion
  • Individual enrolment and multiple-learner licences available

Course Content

In Vitro Diagnostic Regulation (IVDR): Regulation (EU) 2017/746

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PRACTICAL IVDR TRAINING DEVELOPED BY CLINICAL EXPERTS

The In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 sets out the EU regulatory framework for IVDs. Understanding its requirements helps professionals recognise how their work contributes to device safety, performance and regulatory compliance.

Our online IVDR course introduces the regulation with a focus on its application to clinical research. You will explore how device classification and conformity assessment connect with performance evaluation, clinical evidence and the responsibilities of those involved in IVD development and studies.

The training also examines the planning, conduct and documentation of performance studies, alongside technical documentation, regulatory records and preparation for audits and inspections.

You will learn why these responsibilities continue after a device reaches the market, including the role of post-market surveillance and post-market performance follow-up (PMPF).

Practical examples and knowledge checks throughout the course help you connect the requirements with the decisions, documentation and activities you may encounter in your role.

IVDR TRAINING FOR INDIVIDUALS AND CLINICAL RESEARCH TEAMS

Whether you are developing your own understanding of the IVDR or organising training for colleagues, our online course provides a flexible way to build knowledge across clinical, regulatory and quality functions.

INDIVIDUAL LEARNERS

Training for individuals

Our online IVDR training helps you develop your understanding of the regulation, explore its relevance to your role and demonstrate your learning with a certificate on successful completion.

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CORPORATE TEAMS

Corporate training

Provide a shared foundation in IVDR requirements across your organisation. Our team licences allow you to enrol multiple learners, monitor progress and manage training centrally.

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WHAT WILL I LEARN FROM THIS IVDR TRAINING COURSE?

Explain the purpose and scope of the IVDR and its relevance to clinical research professionals

Describe key IVDR requirements relating to IVD classification, conformity assessment, performance evaluation and clinical evidence

Understand the roles and responsibilities of key stakeholders involved in IVD development, performance studies and regulatory compliance

Recognise how IVDR requirements apply to clinical research activities, including performance studies, technical documentation, post-market activities and inspection readiness

FREQUENTLY ASKED QUESTIONS ABOUT IVDR TRAINING

What is the IVDR?

The IVDR is the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746. It establishes EU requirements for devices used to examine samples from the human body to provide medical information, such as diagnostic tests.

It covers areas, including; device classification, conformity assessment, performance evaluation, performance studies and post-market activities.

Can I complete the IVDR course online?

Yes. The course is delivered online and is self-paced, so you can fit your learning around your professional and personal commitments. There are no scheduled classroom sessions to attend.

Can organisations purchase multiple IVDR course licences?

Yes. We offer team licences for organisations training several people or coordinating learning across different functions.

The corporate training options support learner enrolment, progress tracking and centralised administration. Contact us with your approximate learner numbers to request a tailored quotation.

Will I receive an IVDR training certificate?

Yes. You will receive a certificate after successfully completing the course, providing a record of your IVDR training.

The certificate demonstrates course completion; it does not certify a device or organisation as compliant with the regulation.

What makes Integrity Clinical Compliance’s training different?

Our course draws on the experience of clinical research professionals and focuses on how IVDR requirements relate to practical research activities.

Examples, scenarios and case studies help you understand the context behind the requirements, while interactive knowledge checks reinforce your learning. The aim is to help you use that knowledge in your work, from understanding study responsibilities to recognising the importance of complete regulatory records.

Who should complete online IVDR training?

This course is suitable for professionals whose work involves in vitro diagnostic medical devices, performance studies or related compliance activities, including:

  • Clinical research professionals and study monitors
  • Performance study managers and coordinators
  • Investigators and research-site personnel
  • Regulatory affairs professionals
  • Quality assurance and compliance teams
  • IVD manufacturers and development teams
  • Sponsors, CRO personnel and consultants
  • Professionals involved in post-market surveillance and performance follow-up

It is relevant both to people building their initial knowledge and to experienced professionals seeking a structured refresher.

Do I need previous clinical research experience?

No. The course is designed to be accessible to learners with little or no previous clinical research experience.

It also supports professionals who already work in clinical research, quality or regulatory roles and want to expand their understanding of IVD requirements.

Does the course cover performance studies and post-market responsibilities?

Yes. The course addresses performance studies, performance evaluation and clinical evidence, alongside technical documentation and stakeholder responsibilities.

It also introduces post-market surveillance and post-market performance follow-up, helping you understand how evidence gathering and oversight continue throughout the device lifecycle.

If this course isn’t right for you, take a look at our other online clinical courses.