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Starting TBC

5-week online academy

Understand the regulatory requirements under the Medical Device Regulation to ensure compliance throughout the product life cycle

Course Overview

Are you ready for the new Medical Device Regulation (MDR)?

Published on May 5th 2017, the final text of the Medical Devices Regulation constituted major changes for the industry. This flexible online course offers students an excellent opportunity to understand the basics of the entire medical device product lifecycle in the context of these updates.

This course will allow you to engage with a leading expert in the field and come to grips with regulatory affairs, quality management systems, risk management, clinical evaluation requirements and general compliance aspects of medical devices.

The new MDR necessitates a degree of transformation for medical devices manufacturers, importers and distributors, including changes to classification and safety and performance requirements for proving compliance, among others. Designed for those new to medical devices, or need a broad overview of the changes resulting from the MDR, this course will cover a variety of major topics to give an excellent understanding of the area.

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:

  • 9 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?

Industry changes

Grasp the changes that the medical device industry needs to implement to remain compliant with the new regulations

Dossier submission procedures

Understand how to submit your documentation to ensure your device is in line with the updated general safety and performance requirements

Requirements for clinical evidence

Familiarise yourself with the stringent clinical evidence requirements and vigilance reporting

Device classification

 Learn to classify your device under the new guidelines

Post-market and surveillance requirements

Understand the post-market and surveillance requirements

Clinical investigations & evaluations

Discover best practice for clinical investigations and evaluations reporting detailed in ISO 14155

Who is this course for?

This course is suitable for professionals who work in the medical device regulatory industry who need to understand the changes in the EU law. Particular areas may include:

  • Regulatory Affairs
  • Medical Device Development
  • Clinical Investigations
  • Chief Operating Officer – Doctors & Nurses etc.
  • Adverse Events Reporting
  • Research & Development

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


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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:

  • Medical Device Quality Assurance and Regulatory Compliance
  • Medical Instruments and Devices: Principles and Practices
  • Design Controls for the Medical Device Industry, Third Edition
  • Usability Testing of Medical Devices
  • And more