Module 15 2022

19/05/2022

SSCP Template

Healthcare Patient SSCP

Patient SSCP

3. Device description

3. Device description 3.1. Description of the device

● Device description and material/substances in contact with patient tissues ● Information about medicinal substances in the device, if any ● Description of how the device is achieving its intended mode of action ● Description of accessories, if any

3.2. A reference to previous generation(s) or variants if such exist, and a description of the differences 3.3. Description of any accessories which are intended to be used in combination with the device 3.4. Description of any other devices and products which are intended to be used in combination with the device

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

21

SSCP Template

Patient SSCP

Healthcare Patient SSCP

4. Risks and warnings Contact your healthcare professional if you believe that you are experiencing side-effects related to the device or its use or if you are concerned about risks. This document is not intended to replace a consultation with your healthcare professional if needed. ● How potential risks have been controlled or managed ● Remaining risks and undesirable effects ● Warnings and precautions ● Summary of any field safety corrective action, (FSCA including FSN) if applicable

4. Risks and warnings 4.1. Residual risks and undesirable effects 4.2. Warnings and precautions 4.3. Other relevant aspects of safety, including a summary of any field safety corrective action (FSCA including FSN) if applicable

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

22

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