On December 1st 2022, the EU Commission published a document that in sweeping terms describes Non-Invasive Brain Stimulation Technologies (NIBS) as hazardous technologies and reclassified them to the highest risk class (Class III), thereby equalling them to devices such as pace makers and deep brain implants:
“Such products may cause side effects, for example, atypical brain development, abnormal patterns of brain activity, increase metabolic consumption, fatigue, anxiety, irritability, headaches, muscle twitches, tics, seizures, vertigo and skin irritation at the electrode site ...
Such modifications can have long-lasting effects and any unintended effects may be difficult to reverse. Such products should therefore be classified as Class III.”
The EU Ombudsman has now officially confirmed our claim that this reclassification was fundamentally flawed and concluded that the Commission had not sufficiently assessed the evidence and was thus not in a “position to decide” whether a reclassification could be justified. As has been argued elsewhere (e.g. ESBS manifesto, community opinion from Brain Stimulation, our previous article here at Neuromodec) the reclassification itself, its foundation, and the process of introducing it, are deeply problematic. Most significantly, while the reclassification is made in the context of medical technologies used without a medical intended purpose (MDR Annex XVI), the reclassification document itself makes no such distinction. Instead it uses broad and general terms to describe the technologies’ inherent mechanisms as much more extreme than there is any evidence to support, also breaking with the common regulatory practice by arbitrarily mixing risk, side effects, adverse events, and societal risks. It also equates widely different NIBS approaches regardless of intensity or risk profile while at the same time leaving some out - for example it includes very low-risk electrical skin stimulation methods but excludes focused ultrasound (which has the capacity to severely damage tissue).
The most significant issue is that by introducing what is portrayed as protection for the public, the Commission does in effect limit access for doctors and patients to a desperately needed, safe and effective, treatment alternative to current mental health treatments. While in theory the reclassification document relates only to Annex XVI non-medical use, its incorrect and selective depiction of NIBS represents a significant problem for the whole NIBS field as long as it is a legal EU document. Any regulator, clinician, academic or industry representative who claims this has no impact on regulation of research or medical NIBS, has not properly reviewed the wording used by EU regulators to describe the fundamental risks of NIBS. In academia we already see institutions reassessing their willingness to perform NIBS research arguing that the research is too high risk - citing the EU reclassification.
After first trying unsuccessfully to challenge the reclassification directly with the Commission, the case was brought to the EU Ombudsman 21st of January 2023 with two main complaints:
1) Lack of relevant scientific evidence
2) Lack of due process and stakeholder involvement
On April 25th 2024 the Ombudsman concluded in favour of the complaint, supporting both our claims and in clear terms criticised the Commission’s assessment of the quality of the evidence. The Ombudsman also points out that the process input from stakeholders was “very limited” and criticises the Commission for not making public the five documents (criticised by a group of leading NIBS scientists here) they claimed was ‘new scientific evidence’ supporting the reclassification (all documents relevant to the Ombudsman case are publicly available here).
Both the Commission and the complainant accepted the Ombudsman's resolution proposal, which required that the Commission investigate, with the help of competent scientific expertise from the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER), whether new scientific evidence would justify a reclassification. Indicative of the Commission's arrogance, the preceding Ombudsman case and the Commission's acceptance of its conclusion is not mentioned in the work description for SCHEER. Instead, the work description repeats the revoked claim that the reclassification “was based on available scientific evidence“, although this is exactly what the Ombudsman case uncovered that the Commission had not sufficiently assessed.
Contemptuously, the Commission has - despite accepting that they had not properly assessed its scientific foundation and not followed due process - chosen to indefinitely maintain the reclassification in its current flawed form. A scientific opinion from SCHEER is expected by the end of 2025 - marking a three-year anniversary for the introduction of the reclassification. Upon repeated requests in April 2024, March and Sept 2025 for a timeline for the Commission's plans of complying with the agreed Ombudsman solution proposal, we have been informed that they will first await the adoption of the SCHEER opinion (likely in Q1 2026), then they will “assess the suitability of the reclassification” but “a timeline for this process has not been defined yet”. Without a timeline, it makes it impossible to estimate when a rectification can take place - at current rates this could mean the reclassification being in effect for potentially years to come.
As a result, despite the Commission committing to the Ombudsman resolution proposal, there is a legal EU reclassification act in effect indefinitely, grossly misrepresenting the inherent risk associated with critical technologies desperately needed for mental health treatments. It is incomprehensible that for an erroneous reclassification that was initially rushed through to adoption in less than four months (Aug 11 to Dec 1st 2022), no timeline can be provided for its rectification. This is not merely a display of institutional impunity, more importantly it jeopardises public health by limiting patient access to safe, effective, life-saving technologies and threatens the development of the required European medical device and research sector.
The Ombudsman has confirmed that they have no jurisdiction to enforce the actual execution of their solution proposal after it is accepted, thus the only remaining options are to wait indefinitely for the Commission to comply with the decision, or to take the case to court which would risk even further delay any prospect of fair patient access to NIBS technologies.
