The Medical Devices Introductory Course 2020

Case Study Plan

 Remain as one single team of 5 or 6

 Work through the case study assignments for each of the provided case study devices [A-F]

 Prepare materials to illustrate and present your findings for each case study device at Wrap-Up

 The task is (purposefully) TIME CONSTRAINED - manage your time! If you find you can complete the task early, then continue with the additional device (G).

 Be prepared to answer questions to support your case during Wrap-Up

 The case study requires teamwork – please work together as a team, throughout! (including at Wrap-Up)

The Organisation for Professionals in Regulatory Affairs

Case Study Assignments

For each device:

 QUALIFY - Determine regulatory status – is the product a medical device?  CLASSIFY - Determine EU device classification under the MDD and under the MDR

 JUSTIFY - Explain main reasons for chosen classification

 Bonus Points for US and other jurisdictional regulatory designation / classification

The Organisation for Professionals in Regulatory Affairs