Module 14 2022

24/03/2022

POINT TO CONSIDER

● IS THE DEVICE STERILE? – You need to make sure that the packaging materials are compatible with the method of sterilisation chosen, or recommended in the IFU – Potential for interaction between the device and its packaging leading to an undesirable effect? ● HOW WILL THE DEVICE NEED TO BE PACKAGED TO ENSURE PROTECTION FROM DAMAGE AND DETERIORATION DURING SHIPPING? – Need for transit trials?

Interactive Session

The Organisation for Professionals in Regulatory Affairs

7

POINT TO CONSIDER

● WHAT IS THE ASSIGNED SHELF-LIFE? – The packaging must help to assure that the device is maintained and retains its functionality for the stated period of use.

– Stability (accelerated ageing) studies will be needed

– Functionality testing will be needed.

Interactive Session

The Organisation for Professionals in Regulatory Affairs

8

4