Module 14 2022

22/03/2022

Snapshot of STED layout

Adapted from IMDRF, 2019

Masterclass Lecture 10

The Organisation for Professionals in Regulatory Affairs

13

Device Description

Describe the device clearly and in detail • What it looks like • How it works • What it is used for • Classification, and how this was determined – which rule Pictures are helpful for a reviewer Avoid minor details that may change regularly (e.g. …in a bottle with a red plastic cap)

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

14

7