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Fundamentals of EU Regulations for Medical Devices

5-week online course | 2 hours per week

2 March - 10 April 2020

Online Academy

Are you ready for the new Medical Device Regulations (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 needing 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.


  • Grasp the changes that the medical device industry needs to implement to remain compliant with the new regulations
  • Understand how to submit your documentation to ensure your device is in line with the updated general safety and performance requirements
  • Familiarise yourself with the stringent clinical evidence requirements and vigilance reporting
  • Learn to classify your device under the new guidelines
  • Understand the post-market and surveillance requirements
  • Discover best practice for clinical investigations and evaluations reporting detailed in ISO 14155

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 
anne jury circle

Anne Jury

Anne has her own consulting company, advising on regulatory affairs and quality assurance to medical technology industries. Anne previously worked for BSI Product Certification as a medical devices notified body Certification Manager, managing BSI’s regulatory compliance for CE marking to the Active Implantable Medical Devices Directive 90/385/EEC and Medical Device Directive 93/42/ECC. In addition, Anne worked worked for TUV, where she was responsible for the development of the Medical-Health-Sports (MHS) Business Uni

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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