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Fundamentals of the EU IVD Regulation

5-weeks | 1 hour per week

4 November - 8 December 2019

Online Academy

Under the In-Vitro Diagnostics Regulation, the majority of IVDs are self-declared devices. However, under the In-Vitro Diagnostics Regulation (MDR) this majority will require some form of conformity assessment by a Notified Body. The soon-to-be implemented Regulation is drastically different to the current Directive as it imposes new requirements on manufacturers and other economic operators on areas such as conformity, device classification and documentation which impact the entire device lifecycle.

This 5-week course is designed to inform delegates on the full revised scope of the IVDR and will highlight the key areas of change from the pre-existing Directive. Delegates will have access to case studies to illustrate this theory in practice.

Richard Young

Richard Young has over 20 years’ experience in the medical device industry with products such as class 3 implants to electromedical infusion systems. Richard has extensive experience in regulatory affairs, GMP (quality), GLP (laboratory testing) and clinical affairs. Richard has held various positions within industry such as QA/RA Manager and Director, Quality Assurance and Regulatory Compliance at various companies including Biomet, Plasma Surgical and Zimmer Limited

  • Gain a comprehensive insight into the latest developments outlined in the new Regulation
  • Understand the new classification requirements
  • Examine the roles and responsibilities of Competent Authorities, Notified Bodies and Economic Operators
  • Practically analyse the various conformity assessment routes
  • Learn about the key updates to post-market surveillance and vigilance activities
  • Recognise the differences between a technical file and a design dossier and how to compile them 
  • Study the updated labelling and CE marking requirements for your device

This course is relevant to those moving into, or new to IVD regulatory affairs within an IVD company, such as:

  • R&D
  • Regulatory Affairs
  • Clinical Affairs
  • Quality Management
  • Project Management
  • Quality Assurance
  • Professionals looking for a complete update on the IVD requirements
  • Anyone looking to obtain or enhance their understanding of the IVD requirements

MDTI online academies are perfect for busy professionals as they require just 2 hours per week of your time, and include an interactive forum for you to ask direct questions about challenges you are facing to expert course leaders.

Modules are released on a weekly basis so you can pace yourself alongside your peers and you will have access to a comprehensive set of assets to support your learning such as video content, quizzes and case studies.

Watch the Online Academy Video

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