Implementation of the In Vitro Diagnostic Device Regulation for CE Marking On-demand Training Course

The In Vitro Diagnostic Devices Regulation (IVDR 2017/746) is the legislation detailing the requirements which manufacturers have to meet to place in vitro diagnostic devices on the market in the European Union.

The Regulation contains detailed requirements that need to be implemented, and will affect all IVD manufacturers, importers, distributors and EU Representatives.

The IVDR focusses on devices to be safe and effective, emphasizing pre-market requirements, conformity assessment, post-market-surveillance (PMS), and traceability.

This course aims to offer guidance on implementation of the requirements stipulated in the IVDR into your business.

 

BSI’s on-demand courses are market-leading and available 24/7. Developed by top subject matter experts, they contain the same high-quality content you will find in our tutor-led training, but with the added benefit of being able to learn at your own pace and at any time.

How will I benefit?

This course will help you:

  • Take the necessary steps for your organization to meet the IVDR requirement
  • Implement the requirements of the European In Vitro Diagnostics Devices Regulation
  • Execute robust and compliant performance evaluation and post market follow up studies
  • Guide and support other people and partner organisations affected by IVDR