Module 14: Design Development and Certification of Medical Devices

17/11/2023

Content of the STED

The level of information will depend on the Device: High • A new/innovative Class III Device with supporting clinical studies

What about • A Class I Device for a well-established use that would be Self Certified?

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

9

Content of the STED

Is it a single device, or composed of several components? e.g. A wound drainage device may have 3 components that must be taken into consideration: • the cannula, • the tubing • the collector unit. If sold together as a single item, then the HIGHEST class would apply – in this example Class IIa for the cannula (as it is surgically invasive) – the tubing and collector would be Class I

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

10

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