IVDR Fundamentals Training Course

Join our two-day IVDR Fundamentals training course for a comprehensive overview of the new European Regulation 2017/746 for In-Vitro Diagnostic Devices. This course is essential for anyone involved in the IVD industry, from beginners to experienced professionals.

By attending, you will simplify your company’s transition to IVDR making it less complex and less time-consuming. You’ll understand the changes introduced by the new EU regulation and their impact on your organisation. The course will help you develop effective strategies to professionally reply to the new requirements, ensuring your organisation remains compliant and ahead of the curve.

The course agenda includes an introduction to IVD Regulation, requirements to economic operators, classification rules, and conformity assessment procedures. You will also learn about technical documentation, performance evaluation requirements, and traceability (UDI/EUDAMED) requirements. You’ll also learn about post-market surveillance (PMS), vigilance, and market surveillance, ensuring you are well-versed in all aspects of the regulation. You can see more info on the agenda below.

This online instructor-led course is perfect for employees new to the IVD industry, experienced IVD staff with a regulatory background, Regulatory Affairs Officers, managers, and authorised representatives, importers, and distributors. Whether you are just starting in the field or have years of experience, this training will provide valuable insights and updates crucial to your role.

Why take this EU IVDR training course?

• Ensure compliance: Develop effective strategies to professionally reply to the new requirements, ensuring your organisation remains compliant.
• Save your organisation time and money: Find out how to make your transition into IVDR less complex and less time-consuming.
• Boost your expertise: Learn how to identify the changes introduced by the new European Regulation (EU) 2017/746 (IVDR) on in vitro diagnostic medical devices (IVDs) and find out about current developments.
• Gain certification: Receive a globally recognised TÜV SÜD certificate upon completion.

You’ll benefit from training delivered by TÜV SÜD's leading industry experts, small class sizes for personalised learning, and a globally recognised TÜV SÜD certificate upon completion. This is a live online training course but we also offer the option for dedicated in-house training tailored to your organisation.

Equip yourself with the knowledge and skills to comply with the new IVDR regulations confidently. Book your place today and ensure your organisation is compliant and prepared for the future of IVDs.