New European Regulation reclassifies brain stimulation equipment without an intended medical purpose as class III
Disclaimer: This change does not impact Sooma, Sooma’s customers, or patients using Sooma devices.
The European Commission has published standard provisions regarding the reclassification of groups of certain active products without an intended medical purpose with the newly approved Implementing Regulation 2022/2347.
The regulation, which will come into effect on December 21st, is set up to ensure that such devices are built to the highest quality standards and that the risks associated with their use are controlled carefully via the applicable risk management requirements.
One of the groups of products listed in the regulation is “(…) equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain as referred to in Section 6 of Annex XVI to Regulation (EU) 2017/745”.
Brain stimulation devices without intended medical use will now be reclassified as Class III according to the new regulation, the highest possible risk classification.
This change does not impact Sooma, Sooma’s customers, or patients using Sooma devices. Since day one, our focus has been on medical indications and clinical therapy in full compliance with regulators. Thus, Sooma devices will continue to maintain their Class IIa status as brain stimulation devices for intended and effective medical use.
The regulation seeks to amend the new classification rules set up by the new EU Medical Device Regulation, where devices that did not claim a medical purpose could be marketed without appropriate evidence of efficacy and safety. However, regardless of marketing claims, brain stimulation devices are intended to modify neuronal activity with potentially long-lasting effects. Therefore, the European Commission considers that the risks should be controlled before and after placing such devices on the market, barring ineffective, unsafe, or fraudulent devices from the European market.
The change will clarify the provisions of the law for device manufacturers and their customers to ensure that the devices being used in patient care or in development for patient care are built to control the inherent risks in their use and ultimately provide safety benefits to the end user.
For doctors prescribing or patients using neurostimulation products other than Sooma Therapy devices: You may request the device manufacturer to provide their Declaration of Conformity directly. Alternatively, the device’s User Manual can be consulted for the stated intended use. If the intended use does not specify a medical condition, the device is subject to this regulation.
Sooma tDCS has an intended medical use for treating depression and chronic pain, such as fibromyalgia and chronic neuropathic pain. As such, our users and devices are not affected by this change.
While the importance of the device’s intended use might not be evident, this statement guarantees that the manufacturer has provided objective evidence about their device being truly effective for that particular use. Outside of the intended use, the benefit-risk ratio of the device is unclear, and any realized patient or user risks are not covered by the manufacturer’s liability.
TDCS is the treatment method offered by Sooma for depression (Sooma Depression Therapy, indicated for Major Depressive Disorder) and chronic pain (Sooma Pain Therapy, indicated for Fibromyalgia and chronic neuropathic pain). By using Sooma devices, you ensure that you are performing a safe and effective patient treatment, should it be in the hospital or at patients’ homes, with legal, regulated, tested, and effective equipment that complies with the latest EU regulations and features all the recommended elements listed on this article.
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