Medical Devices Directive

Expert workshop on cognitive enhancement device regulation: Are there ‘two worlds’ of devices?

Last week, we held an expert workshop with key stakeholders to discuss our recent Oxford Martin School policy paper. Our policy paper put forward proposals for how we thought cognitive enhancement devices such as brain stimulators should be regulated. At present, if these sorts of devices do not make medical treatment claims (but instead claim to make you smarter, more creative or a better gamer, say) then they are only subject to basic product safety requirements. In our paper we suggested that cognitive enhancement devices should be regulated in the same way as medical devices and discussed how this could be implemented. Indeed, the devices that are being sold for enhancement of cognitive functions use the very same principles as devices approved by medical device regulators for research into the treatment of cognitive impairment or dysfunction associated with stroke, Parkinson’s disease and depression (amongst other conditions). Being the same sorts of devices, acting via similar mechanisms and posing the same sorts of risks, there seemed to be a strong argument for regulation of some form and an equally strong argument for adopting the same regulatory approach for both medical and enhancement devices.

Having published our paper, we were very keen to hear what people more closely involved in making policy and drafting legislation thought of our proposals. Individuals from the Medical and Healthcare Products Regulatory Agency, the EU New and Emerging Technologies Working Group, a medical devices company, the Nuffield Council on Bioethics, and experts on responsible innovation and on brain stimulation joined us. Overall, the response to our recommendations was positive: all participants agreed that some regulatory action should be taken. There was a general consensus that this regulation should protect consumers but not curtail their freedom to use devices, that manufacturers should not be over-burdened by unnecessary regulatory requirements, and that innovation should not be stifled. Continue reading

“Whoa though, does it ever burn” – Why the consumer market for brain stimulation devices will be a good thing, as long as it is regulated

In many places around the world, there are people connecting electrodes to their heads to electrically stimulate their brains. Their intentions are often to boost various aspect of mental performance for skill development, gaming or just to see what happens. With the emergence of a more accessible market for glossy, well-branded brain stimulation devices it is likely that more and more people will consider trying them out.

Transcranial direct current stimulation (tDCS) is a brain stimulation technique which involves passing a small electrical current between two or more electrodes positioned on the left and right side of the scalp. The current excites the neurons, increasing their spontaneous activity. Although the first whole-unit devices are being marketed primarily for gamers, there is a well-established DIY tDCS community, members of which have been using the principles of tDCS to experiment with home-built devices which they use for purposes ranging from self-treatment of depression to improvement of memory, alertness, motor skills and reaction times.

Until now, non-clinical tDCS has been the preserve of those willing to invest time and nerve into researching which components to buy, how to attach wires to batteries and electrodes to wires, and how best to avoid burnt scalps, headaches, visual disturbances and even passing out. The tDCS Reddit forum currently has 3,763 subscribed readers who swap stories about best techniques, bad experiences and apparent successes. Many seem to be relying on other posters to answer technical questions and to seek reassurance about which side effects are ‘normal’. Worryingly, the answers they receive are often conflicting. Continue reading

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