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Starting 12 October 2020

5-week online academy

Decode the new European IVD regulation - understand the key areas of impact for IVDs within the new regulatory requirements

Course Overview

The in-vitro diagnostic sector has undergone a regulatory transformation, similar to that seen in medical devices. Under the existing Directive, the majority of IVDs are self-declared devices. However, under the In-Vitro Diagnostics Regulation (IVDR) they 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 will inform you of the full revised scope of the IVDR and will highlight the key areas of change from the pre-existing Directive. Once completed you will be better placed to carve out a strategy to manage transition, ensuring your organisation and its product(s) remain compliant. To support you in the learning process you will have access to case studies to illustrate this theory in practice.

Online Academies

MDTI online courses are on-demand digital courses developed by our expert faculty providing learning on a range of technical topic areas.

Over 5 weeks students will learn through:

  • 5 modules, split up into multiple bitesize recorded videos
  • Quizzes to test your knowledge
  • Revisiting the content with unlimited access to all the materials for 3 months
  • Participating in the discussion forum to interact with other students
  • Interacting with the trainer through the forum during the course
  • Additional content such as materials and white papers available to download

Delegates will receive login instructions within a week of the course start date. If you have any questions please contact

What will you learn?

IVD regulations
IVD regulations

Gain a complete overview of the latest IVD regulations

Performance evaluation studies
Performance evaluation studies

Understand the requirements for performance evaluation studies

Risk management
Risk management

Examine the role of risk management throughout the lifecycle of your diagnostic

Quality management
Quality management

Assess the importance of a quality management system within your organisation

Upcoming changes
Upcoming changes

Appreciate future changes to the industry with an overview of the new IVD Regulation

Who is this course for?

  • Those moving into Regulatory Affairs from other areas within an IVD company (R&D, Marketing and others)
  • Those new to the IVD Regulations with a background in medical devices, pharmaceuticals or biotech
  • Professionals working in areas such as marketing or manufacturing wanting a complete update on the IVD requirements

Find out more about online academies...

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.

On average, delegates of our online academies said...

for quality of content
applied content during the course to their role
for quality of delivery

CPD Certified

Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.

25% discount on Routledge books

As a student on the course you will receive a 25% discount on any Routledge books or eBooks. To view the full product range visit the Routledge website

Examples of books and eBooks within medical devices include:

  • ISO 13485:2016: A Complete Guide to Quality Management in the Medical Device Industry, Second Edition
  • ISO 9001: 2015 - A Complete Guide to Quality Management Systems
  • Medical Device Quality Assurance and Regulatory Compliance
  • Medical Device Regulatory Practices: An International Perspective
  • And more