Following an Ombudsman proposal, the European Commission has agreed to verify whether the information it used to revise the risk classification of brain stimulation devices for non-medical purposes is representative of the most recent scientific evidence.

These devices are said to improve wellness and cognitive function through the application of electrical currents, magnetic fields, or electromagnetic fields to modify neuronal activity in the brain.

In response to a request from six EU Member States, the Commission recently reclassified these devices to the highest risk class within the Medical Devices Regulation, meaning that the products have to comply with more demanding requirements to be sold in the EU.

The Ombudsman received several complaints from stakeholders following the reclassification. After opening an inquiry, she found that the Commission had not verified whether the information provided by the six Member States was representative of the most recent scientific evidence on the subject.

The Commission agreed to ask the Scientific Committee on Health, Environmental and Emerging Risks to issue a scientific opinion on the risk posed by the use of brain stimulation devices for non-medical purposes and to then assess whether any follow-up action is needed.

As the Ombudsman had also made some observations on the collection of feedback in this case, the Commission said it would consider extending the consultation period of public consultations launched during the summer. It also said that in future it would include as much information as possible on the related scientific evidence when holding a consultation on a new measure.