Course description
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 about the key requirements of risk classification under the MDR, gain a better understanding of the risk classification rules, the need to classify and why the intended purpose of a device is important.
On-demand - training that’s even more flexible
This short course aims to give you a better understanding of the Risk Classification requirements as per the EU MDR (2017/745). We discuss why there is a need to classify, the importance of stating the intended purpose and how this plays a role in applying the correct conformity assessment procedures.
Upcoming start dates
Suitability - Who should attend?
Quality, Regulatory, Technical professionals working in the Medical Device industry
Outcome / Qualification etc.
This course will help you:
- Appreciate the risk classification requirements as per the MDR
- Gain an understanding of the risk classification rules with typical device examples
Training Course Content
By the end of the course, you will be able to:
- Establish the requirements of Risk Classification as per the MDR Annex VIII
- Understand the medical device risk classification rules
- Appreciate the importance of the intended purpose driving the risk classification and selecting the appropriate conformity assessment procedure
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