EU Regulations Essentials

On completion of the MDR essentials course, successful Learners will have the knowledge needed to:

1. Explain the history, purpose, and structure of the EU MDR
2. Describe the key changes to the EU MDR from the MDD
3. Identify the different roles and responsibilities associated with the EU MDR
4. Outline the requirements for placing a medical device on the market

On completion of the IVDR essentials course, successful Learners will have the knowledge needed to:

1. Explain the history, purpose, and structure of the EU IVDR
2. Describe the key changes to the EU IVDR from the IVDD
3. Explain what an IVD medical device is
4. Describe the types of IVD devices that are covered by the regulation
5. Outline some other key aspects of the new EU IVDR

These courses are for organizations who wish to provide their staff with a short, general overview of either the EU MDR and/or EU IVDR. There is a minimum order requirement for this training.

Please note, these are separate courses per EU regulation (not combined).

Successful completion will entitle each Learner to receive a digital Certificate of Completion.

In order to successfully complete either course, each Learner will need to:

• Complete all eLearning modules and obtain 70% or higher in the final assessment (MCQ-based)

There are recommended requirements for each Learner in wishing to complete any of our eLearning modules. In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well. Read the full technology requirements here.