The Medical Devices Regulation (MDR) is the legislation detailing the requirements that manufacturers must meet to place medical devices on the market in the European Union.

Learn some key requirements about Annex VII of the MDR and gain a better understanding of why notified bodies may be seen to behave differently and in a much more detailed way than what organisations may have previously experienced.

Course aim

This short mini course aims to provide some insight into one of the key annexes in the Medical Device Regulation (MDR) – Annex VII. Manufacturers may not be so familiar with this particular annex as the requirements are mainly aimed at Notified Bodies. This course also links some of the clinical evaluation requirements from the MDR.

How will I benefit?

This course will help you:

• Appreciate the requirements of Annex VII from the MDR
• Gain a better understanding of some key Notified Body requirements within the MDR

What will I learn?

By the end of the course you will be able to:

• Establish the requirements detailed in Annex VII of the MDR
• Appreciate the Notified Body prospective and approach when assessing against the MDR
• Gain an overview of the clinical evaluation requirements
• Understand audit duration and approach of Notified bodies as per the MDR

Who should attend?

Quality, Regulatory, Technical professionals working in the Medical Device industry

How will I learn?

This is an online, interactive on-demand course.

Courses are available 24/7 and you can learn at any time and from any place that suits you – you just need an internet connection.

You can learn as fast or as slowly as you want to. You can also take breaks at any time in the course and pick up where you left off when you are ready to continue.

During the access period, you can go back and repeat parts or all the course to refresh and reinforce what you have learned.

The course content is both detailed and engaging, with explanations, activities, and knowledge checks to enhance your learning.

What will I gain?

On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.

Prerequisites

There are no formal prerequisites for this course.

Duration

60 minutes