Regulatory requirements for Medical devices
This brief video series provides an overview of the European Union’s Medical Device Regulation (MDR). If you’re involved in the design and development of medical devices and want to learn more about the current regulations, this series should be helpful.
We go over a lot of the issues covered in the MDR, such as what medical devices are, what laws regulate the marketing claims that can be made about them, and how MDR development connects to worldwide harmonized standards.
We go through a lot of the responsibilities that designers and manufacturers have, such as technical documentation, traceability, risk management, and a lot of other information that I hope you find helpful. As we go along, we’ll also indicate where you may get further information on each issue.
In this series of Regulatory requirements, we’ll concentrate on components of the MDR that pertain to the design and development of devices in preparation for sale, rather than distribution, post-market obligations, or the restrictions imposed on notified entities, all of which are addressed in the MDR.
Whether you’re just starting out in the medical device sector or seeking to brush up on the current regulations, we hope you’ll find this series helpful and that it will help you advance your knowledge.
Engineers and designers interested in learning more about the EU’s Medical Device Regulation should take this course (MDR)
What Will You Learn?
- The Medical Device Regulation's requirements and structure (MDR)
C2 Introduction Assorted Interviews00:00