The regulation of cognitive enhancement devices: extending the medical model

Hannah Maslen, Thomas Douglas, Roi Cohen Kadosh, Neil Levy, Julian Savulescu

Research output: Contribution to journalArticlepeer-review

58 Citations (Scopus)
74 Downloads (Pure)


This article presents a model for regulating cognitive enhancement devices (CEDs). Recently, it has become very easy for individuals to purchase devices which directly modulate brain function. For example, transcranial direct current stimulators are increasingly being produced and marketed online as devices for cognitive enhancement. Despite posing risks in a similar way to medical devices, devices that do not make any therapeutic claims do not have to meet anything more than basic product safety standards. We present the case for extending existing medical device legislation to cover CEDs. Medical devices and CEDs operate by the same or similar mechanisms and pose the same or similar risks. This fact coupled with the arbitrariness of the line between treatment and enhancement count in favour of regulating these devices in the same way. In arguing for this regulatory model, the paper highlights potential challenges to its implementation, and suggests solutions.
Original languageEnglish
Pages (from-to)68-93
Number of pages26
JournalJournal of Law and the Biosciences
Issue number1
Publication statusPublished - Mar 2014
Externally publishedYes

Bibliographical note

Copyright the Author(s) 2014. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.


  • Cognitive enhancement devices
  • Medicines and Healthcare Products Regulatory Agency: medical devices
  • Regulation
  • Transcranial direct current stimulation


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