Module 16 2024

22/10/2024

Fault/Negligence Liability

Manufacturer is responsible if negligent and product injures somebody

Negligent if fail to take appropriate corrective action

The Organisation for Professionals in Regulatory Affairs

5

5

Fault/Negligence Liability (cont.)

Judged against “reasonable” conduct

● magnitude of the risk, practicality and costs of avoidance, likelihood and consequences of injury ● “state of the art” – legal, regulatory, scientific and industry standards at that time

Duty of care on everybody involved in the supply of medical devices

● regulatory authorities? ● notified bodies?

The Organisation for Professionals in Regulatory Affairs

6

6

3