EU Reclassification of TMS and tDCS to Class III - Action to be taken
The first webinar of the European Society for Brain Stimulation was held on the 27th of January, 2023. The theme of the meeting was the new MDR (please see our manifesto). The related paragraph:
- Section 7 of (EU) 2022/2347
According to available scientific evidence on 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, such as those for transcranial magnetic stimulation or transcranial electric stimulation, the use of 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. While such equipment is not surgically invasive, the electrical currents or magnetic or electromagnetic fields do penetrate the cranium to modify neuronal activity in the brain. 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.
Shortly, on the 28th of July “certain Member States jointly requested the reclassification of several active products without an intended medical purpose”. On the 11th of AugustEU Medical Device Group (SANTE.D.3) published draft for hearing, only 21 comments were submitted, most of them not related to NIBS. On the 1st of December the new regulation was published, with a final acceptance date of 22nd of December 2022.
It was extensively discussed, what we can do as a society against the new classification. Unfortunately, blocking or changing the decision of the Commission to change classification of NIBS is not possible any longer, this is in force, as you can see in the letter that you got back from the SANTE group (the first step of protestation).
Other plans are include:
(i) Engage with relevant stakeholders about our position,especially with those in the EU and national agencies that interpret the MDR and show them how we think the changes should be understood. At the EU level, this is the Medical Device Coordination Group (https://health.ec.europa.eu/system/files/2022-10/mdcg_md-ivd_members_en.pdf).
(ii) Put out a visible paper with many stakeholders in prestigious journal laying down the problem and the possible solution. This position paper should contain a legal analysis, an empirical part about the supposed risks of NIBS, and some remarks about the negative impact, which a broad understanding of the changes would have on research and patient care.
With a common effort we can reach that the:
1. Reclassification should be paused / retracted
2. Revised version of this reclassification document should be released for hearing
3. Hearing input that is collected from experts from the brain stimulation field, would be implemented
a. New updated version should be adopted with a clear distinction between NIBS technologies and with proper and correct descriptions
b. With a list of side/adverse effects for each technology and related classification
c. Medical/non-medical differences (intended/non-intended purpose) should be clearly addressed, including basic research
Indeed, during the webinar it became clear that the definition of intended use/purpose in the NIBS area is somewhat contradictory. The intended purpose describes the intended medical use—not the specific product features or specifications —and has to be formulated in a clear, precise, and unambiguous way. The intended use has to be consistent throughout the entire technical documentation and in all future documents on the device. The intended purpose is a core part of the technical documentation (Annex II. 1.1 MDR), andrequires a general description of the device that includes the intended purpose. The intended purpose should be developed together with two other statements that are part of the technical documentation:
- a satement that includes the information about the intended patient population, medical conditions, indications, and contraindications,
- The information on the principles of the operation of the device and its mode of action, scientifically demonstrated, if necessary.
Unfortunately, with the critical lack of Notified Bodies to approve the MDR compliance, this will potentially continue being a problem for a long time - the EU has proposed to prolong the transition period until 2028:
In order to increase our efforts, initiating a complaint process by the EU Ombudsman is suggested, by filling out a template here:
https://www.ombudsman.europa.eu/en/complainant-login
After creating your individual account you may use this template: template form can be downloaded below (as a Word .doc file)
Please not that the Webinar has a limit of 100 attendees and therefore, your registration form serves the solely purpose of securing your attendance.