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Fundamentals of the EU IVD Regulation

5-weeks | 1 hour per week

Starts 4 March 2019

Online Academy

Under the Medical Device Directive (MDD), the majority of IVDs are self-declared devices. However, under the Medical Device Regulation (MDR) the 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 life-cycle.

These are but a few of the significant changes to the European legislation applicable to IVDS and, in a highly regulated industry, the stakes are high for failure to comply. Throughout this course you will learn about the revised scope of the IVDR and the impact it will have on your organisation. You will cement this knowledge through case studies and comprehensive learning materials, ensuring you are prepared for, and compliant to, the upcoming changes.

What is an Online Academy course? 

Online academy is a new online, interactive and engaging education tool designed to maximise learning for professionals with busy schedules and/or small training budgets.

The online academy brings alike professionals together and gives you the opportunity to share ideas and questions via the discussion forum creating your own professional community. Our on-demand feature means the content is available as and when you need it allowing greater flexibility to your professional development and learning.

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 how to classify your device and distinguish it from others
  • Examine the roles and responsibilities of Competent Authorities, Notified Bodies and Economic Operators
  • Critically 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

What happens during an Online Academy course?

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This online academy course can be accessed from 4 March 2019. 1 module will be uploaded per week, allowing you to study at your own pace. Your trainer will welcome any questions that arise throughout your course.

Please note that full payment must be made prior to the course start date in order to receive your login details to begin the course.

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