The Medical Devices Introductory Course 2020

Case Study Plan

 Remain as one single team of 5 -6 throughout the workshop (note: same teams as Case Study 1)

 Select one device from Case Study 1 [A-F], plus either device G or H.

 Work through the case study assignment for your two selected case study devices and also for your ”Innovation”. [Three devices in total].

 Prepare materials to illustrate and present your findings at the Feedback session

 The task is (purposefully) TIME CONSTRAINED - manage your time!

 Be prepared to answer questions to support your case during Feedback

 The case study requires teamwork – please work together as a team, throughout! (Including at Feedback)

The Organisation for Professionals in Regulatory Affairs

Case Study Assignments

For the selected device(s) and for your own innovation ...

 Reconfirm (or for Device G or H and your Innovation determine) QUICKLY the classification of the device  Based on the device classification, propose a strategy for CE marking  Determine the Conformity Assessment Procedure approaches available for the device and select one approach to support your CE marking strategy  Identify the key GSPRs that will apply and thereby the key data requirements for CE marking  Outline the Technical Documentation required in order to CE mark the device – e.g.: key contents  Map the pathway to the CE Mark, including: key steps, costs and time critical tasks

The Organisation for Professionals in Regulatory Affairs