Requirements of the Medical Device Regulation 2017/745 (MDR)

This two-days medical device training outlines the key requirements, concepts and overall process for CE marking under the medical device regulation. It’s suitable for anyone working in regulatory affairs/quality assurance or staff partnering with medical device manufacturers.

This stage of your learning journey creates a solid base for implementing your own CE marking projects. It provides essential knowledge about EU medical devices and regulatory affairs from all areas of an organization. It also explains the demands that fall on subcontractors, importers and distributors.

After completing this medical device training, you will have a sound understanding of the medical device regulation and be able to communicate it to others. You will also gain eight CPD points and take away comprehensive training course notes.

How will I benefit?

This course will help you:

  • Understanding of the European Medical Device Regulation 
  • Be able to explain the impact of the regulations within your organization