The European Society for Brain Stimulation opposes EU reclassification of TMS and tDCS, claiming a flawed safety assessment

Man­i­festo: Oppo­si­tion to EU Reclas­si­fi­ca­tion of TMS and tDCS equip­ment to Class III devices based on flawed evi­dence (Euro­pean Soci­ety for Brain Stimulation):

It has recent­ly come to our atten­tion that the EU has reclas­si­fied the NIBS equip­ments includ­ing rTMS and tDCS, as Class III devices, the cat­e­go­ry of high­est risk, sim­i­lar to inva­sive treat­ments, such as deep-brain stim­u­la­tion implants. This reclas­si­fi­ca­tion has a major impact on our field, not only for man­u­fac­tur­ers, but also for researchers, clin­i­cians and patients and we judge this reclas­si­fi­ca­tion a mis­take. First, the evi­den­tial basis for this change is a flawed assess­ment of the safe­ty lit­er­a­ture. Sec­ond, the con­sul­ta­tion process has occurred with­out input from spe­cial­ists or stake­hold­ers pro­fes­sion­al­ly active in the field of NIBS. Nei­ther the ESBS nor Nation­al Soci­eties of Brain Stim­u­la­tion nor indi­vid­ual experts with­in the Euro­pean NIBS com­mu­ni­ty were con­sult­ed on this change.

.. Although this new reclas­si­fi­ca­tion cur­rent­ly refers only to “prod­ucts with­out an intend­ed med­ical pur­pose”, the evi­dence adduced about the risks and adverse effects of rTMS and TES, — which serves as the jus­ti­fi­ca­tion for this reclassification‑, is grave­ly flawed. The EU has appar­ent­ly assessed that NIBS pos­es a greater risk to patients’ safe­ty than pre­vi­ous­ly thought. This assess­ment is based on incor­rect state­ments about rTMS and low inten­si­ty TES that are con­tra­dic­to­ry to the avail­able sci­en­tif­ic evi­dence, and many of the stat­ed claims and assump­tions are false (e.g., it is claimed that TMS/TES can induce “atyp­i­cal brain devel­op­ment” or “abnor­mal pat­terns of brain activ­i­ty”). Like­wise, the promi­nent men­tion­ing of rTM­S/TES-relat­ed seizure risks con­tra­dicts the most recent con­sen­sus state­ment in the field based on actu­al clin­i­cal data which demon­strat­ed that observed seizure rates are so much low­er than pre­vi­ous guide­lines advised, that the pri­or cau­tion about seizure risk is no longer sup­port­ed by sci­en­tif­ic evi­dence (Rossi et al., 2020). To put this into per­spec­tive, the like­li­hood of a seizure from rTMS (0.003%) is low­er than that asso­ci­at­ed with the use of anti­de­pres­sants and antipsy­chotics (0.1–1, 5%), which are one of the most fre­quent­ly pre­scribed treat­ments for depres­sion (George et al., 2013). More­over, when such seizures occur they do so most­ly out­side the clinician’s office, by con­trast with rTMS (Per­era et al., 2016). For low inten­si­ty tDCS, tACS, tRNS seizure risk is com­plete­ly absent…

As an organ­i­sa­tion and rep­re­sen­ta­tives of NIBS clin­i­cians and pro­fes­sion­als from across Europe, we, the ESBS, there­fore dis­agree with this EU deci­sion and in par­tic­u­lar with the fac­tu­al­ly incor­rect jus­ti­fi­ca­tions of that deci­sion to reclas­si­fy TMS and TES as inva­sive tech­nolo­gies that require med­ical class-III clas­si­fi­ca­tion. The impact of this reclas­si­fi­ca­tion will result in high­er costs, low­er acces­si­bil­i­ty for patients to treat­ment and sub­stan­tial delays in NIBS devel­op­ment for new clin­i­cal and research indi­ca­tions.  … There­fore, if you are in agree­ment with the con­cerns stat­ed above, we kind­ly ask you to protest this deci­sion by send­ing an email to sante-med-dev@ec.europa.eu.

Upcoming webinar to discuss manifesto:

• Jan­u­ary 27th, 11:30am US East­ern Time/ 5:30pm Europe CET time
• Reg­is­tra­tion required: HERE

News in Context:

• Com­bined tDCS neu­rostim­u­la­tion and cog­ni­tive train­ing found to improve work­ing mem­o­ry among old­er adults–especially those with low­er start­ing capacity
• Study: Per­son­al­ized, closed-loop neu­ro­mod­u­la­tion can (one day) become a “pace­mak­er for the brain”