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Introduction

Learn about the structure and scope of the IVDR including classification and conformity routes, safety and performance requirements, and how to develop a robust post-market surveillance system under the IVDR.

Who should attend?

Individuals responsible for regulatory compliance working in an organization involved in any aspects of in vitro diagnostic device manufacturing, designing, marketing or the supply chain.

What will you learn?

  • To apply the requirements of EU 2017/746
  • The European regulation CE marking approach for medical devices including its legal and operational basis
  • Structure and scope of the IVDR including classification and conformity routes
  • To review the safety and performance requirements checklist applicable to CE marking under the new regulation
  • Create technical documentation to support the product throughout its life cycle
  • Level of clinical evidence necessary to demonstrate conformity
  • Develop a robust and proactive post market surveillance system under the new IVDR including vigilance reporting and monitoring
  • Regulatory significance of a robust quality management and risk management system
  • To gather the business impacts of the regulation and start to develop a transition plan.

What do you need to prepare?

  • Basic knowledge of medical device manufacturing, design and marketing with a detailed understanding of quality management systems
  • Ideally to have attended LR’s Introduction to the IVDR prior to attending this training course.

What's included?

  • Training course materials
  • Lunch and refreshments for public attendees only
  • Certificate of attendance.

Training from LR

With Lloyd's Register, you can learn in the way that works for you. We offer courses in a range of styles, from in-house to virtual classroom. Find out more about Ascend Training Courses from Lloyd's Register. 

Training from LR

With Lloyd's Register, you can learn in the way that works for you. We offer courses in a range of styles, from in-house to virtual classroom. Find out more about Ascend Training Courses from Lloyd's Register. 

Your future development

Course length

Two days.

Certification with Exemplar Global

For an additional $99 USD you can also obtain an Exemplar Global Course Certification for your course.

What are the advantages of adding the Exemplar Global Certification?

With the additional Exemplar Global Course Certification, you will get access to:

  • The Exemplar Global Work Style Behavioural Assessment
  • One-Year Graduate Certification
  • Use of Exemplar Global’s brands and logo to promote your certification
  • Access to Exemplar Global Webinars and Online events
  • Access to Exemplar Global online resources, including Auditor OnLine and regular Job Board notifications
  • Access to the social community of graduates
  • An innovative, continual learning environment for learners and graduates
  • Ongoing support for an entrepreneurial career track for graduates and learners

How to add Exemplar Global Certification to your training course?

If you're booking online, you can add the option of Exemplar Global before you proceed to checkout or contact our team directly.

Find out more

Contact us to learn more about IVDR training.

Register interest

Course Type

  • Public
  • In-house

There are no dates available for this course at the moment. Get in touch with our team to request booking on the next date.

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