By the end of this chapter, the reader should be able to:
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Explain the purpose and structure of medical device regulation in the EU, UK, and US, and describe how electrical stimulation devices are classified within each framework
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Identify the key safety standards (IEC 60601, ISO 13485, ISO 10993) that underpin device certification and explain what they require in practical terms
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Describe the regulatory and economic factors that drive the cost differential between medical and consumer devices, and explain the manufacturer withdrawal concern
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Verify whether a device has appropriate regulatory clearance and recognise red flags for unregulated or consumer-grade devices marketed for clinical use
in Chapter 5, we described experiments with electricity at Glasgow University. This was the era in which Mary Shelley published Frankenstein, and scientists around the world were actively exploring the link between electricity and life.