Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (Text with EEA relevance)

• (i) description of the minimum homogeneity of the treatment spot;

• (j) description of requirements for the spatial distribution of the treatments spots, taking into account that overlapping treated areas shall not lead to overexposure;

• (k) safety features of the device;

• (l) the expected lifetime of the device;

• (m) the expected stability of performance;

• (n) cosmetics and drugs interacting or expected to interact with the treatment and their description;

• (o) other sources of radiation, such as prolonged exposure to sun light or sunbeds, that might increase the risks;

• (p) for devices for professional use, a requirement for the user to provide the consumer with a copy of the annex provided for in Section 6.11 before the consumer is treated with the device.

• 6.2.With the exemption of devices for hair removal where excessive hair is not attributed to a medical condition, the manufacturer shall advise the users and the consumers to undergo a medical consultation including a diagnostic examination of the skin areas intended for the treatment. Manufacturers shall advise users not to treat any consumers prior to obtaining documentation from such consultation.

• 6.3.The instructions for use shall clearly describe requirements for cleaning and maintenance. For devices intended for professional use, the instructions for use shall include the measurement of light energy density and required safety measures, performed at least annually.

• For devices for professional use, the manufacturer shall also instruct on how to ensure constant performance and recommend at least an annual electrical safety test and maintenance.

• 6.4.The instructions for use shall clearly describe the operating environment and the conditions in which the devices can be operated safely. For devices for professional use, the instructions for use shall also include:

• (a) the description or a listing of appropriate accessories or conditions of other products used in the procedure;

• (b) the safety precautions to be taken, which include the use of non-reflective instruments (no mirrors shall be used), the use of absorbing or diffusing surfaces of tools as well as the avoidance of inflammable products and substances and, where applicable, the need to provide adequate room ventilation;

• (c) an adequate warning notice outside the procedure room.

• 6.5.The instructions for use shall highlight the need:

• (a) to avoid at all times exposure of eyes to emitted light;

• (b) for users, consumers and any other person likely to be exposed to the radiation due to reflection, misuse or mishandling of the emitting device to wear appropriate eye protection during treatments with intense pulsed light or laser devices, especially when these devices are to be used close to the face.

• 6.6.The instructions for use shall clearly indicate for which consumers, on which parts of the skin, on which types of skin and for which conditions of skin the device shall not be used.

• 6.7.The instructions for use shall clearly indicate that the device is not to be used on skin parts which have an increased likelihood of skin cancer, open wounds or rashes, or swollen, red, irritated, infected, or inflamed areas or skin eruptions. In addition, the instructions for use shall give information about further contra-indications such as photosensitive epilepsy, diabetes or pregnancy, if applicable.

• 6.8.For devices intended to deliver a permanent change of the appearance, the instructions for use shall indicate that they shall not be used on persons who are less than 18 years old.

• 6.9.For devices for professional use, the manufacturer shall ensure that all appropriate information is made available to the healthcare professional or service provider in order for them to be able to ensure that professional users are evaluating consumers. This includes consumers’ suitability for treatment with devices and counselling them appropriately and adequately with respect to risks and potential outcomes of the procedure, taking into account the consumers’ health history and the medications they take.

• 6.10.For devices for home use, the instructions for use shall contain the internet address where the videos with instructions made available in accordance with Section 5.4. can be found.

• 6.11.The instructions for use of devices for professional use shall contain an annex, written in a language commonly understood by lay persons and in the form that is easy to be handed over to all the consumers. The annex shall contain:

• (a) information listed in Section 12.1, points (a), (b) and (c), of Annex I;

• (b) the statement “The users received appropriate training on the conditions to safely use the device.”, where relevant;

• (c) information on when and how to report undesirable side-effects to the manufacturer;

• (d) a recommendation to undergo a medical consultation, including a diagnostic examination, of the skin areas intended for the treatment.

ANNEX VII

Scope

• 1.This Annex applies to 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 listed in Section 6 of Annex XVI to Regulation (EU) 2017/745. Such equipment includes devices for transcranial alternating current stimulation, transcranial direct current stimulation, transcranial magnetic stimulation and transcranial random noise stimulation. This Annex does not apply to invasive devices.

Risk management

• 2.When carrying out the risk management process provided for in Annex I to this Regulation, among risks associated with the device, manufacturers shall consider the specific risks listed in Section 3 of this Annex and, where relevant to the device, adopt the specific risk control measures listed in Section 4 of this Annex.

3. Specific risks

• 3.1.When carrying out the risk management process, special care shall be taken as to the placement of the electrodes and the strength, waveform, duration and other parameters of the electrical current and magnetic fields.

• 3.2.Manufacturers shall take into account the following aspects and related risks:

• (a) the incorrect placement of electrodes and coils may result in failed performance, enhanced electrical currents in tissue or unintended neural responses;

• (b) brain stimulation may have very different neural responses and thus unintended effects on different groups of persons. Some groups may be particularly vulnerable: persons who are less than 18 years old, young adults, pregnant women, psychiatric patients, persons with psychological disorders or medical conditions affecting the central nervous system, alcohol addicts, users of addictive substances and other substances that modify a person’s natural perception;

• (c) the presence of active implantable or body-worn medical devices and/or metallic passive medical devices or other metallic objects present on or inside the body may give rise to specific risks arising from the application of electrical energy and magnetic fields;

• (d) excessive, frequent and cumulative long-term use may result in unforeseen neural effects which in some cases might result in structural changes in the brain.

• 3.3.Manufacturers shall analyse, eliminate or reduce as far as possible risks related to the following hazards or harms:

• (a) psychological risks;

• (b) neural and neuro-toxicity risks;

• (c) short-term, medium-term and long-term cognitive side-effects, such as compensatory trade-offs (for example the decline or sub-serving of brain regions which are not stimulated);

• (d) transient auditory threshold shift or tinnitus;

• (e) long-term side-effect changes of the brain functioning;

• (f) hazards linked to the long-term effects of repeated stimulation;

• (g) hazards linked to the use of the device in certain environments highly stimulating or attention demanding;

• (h) atypical or other idiosyncratic effects;

• (i) specific hazards arising at the interface between electrodes and skin;

• (j) electromagnetic interference or injury caused by interaction with active implants (for example pacemakers, implanted cardioverter-defibrillators, cochlear implants, neural implants), active devices (for example neural stimulation devices, medication infusion devices), non-active metallic implants (for example metallic dental implants) or body-worn devices (for example biosensors);

• (k) hazards associated with device usage after intake of alcohol and/or soft-drugs and/or central nervous system stimulating substances/pharmaceuticals;

• (l) hazards associated with possible potentiating effects of combined use (usage of few/several devices in the same time targeting same person or different person) and reasonable foreseeable misuse.

4. Specific risk control measures

• 4.1.When applying Section 4.2 of Annex I, unless there is specific evidence for safe use, the following categories of consumers shall be excluded:

• (a) persons with a history of epilepsy;

• (b) persons undergoing pharmaceutical treatment for conditions related to the central nervous system;

• (c) persons undergoing therapeutic treatment which change the excitability of the central nervous system;

• (d) users of illicit substances or other substances that modify a person’s natural perception regardless of whether those are commonly understood as therapeutic drugs;

• (e) persons who have a tumour in the central nervous system;

• (f) persons who have vascular, traumatic, infectious or metabolic lesions or diseases of the brain;

• (g) persons who suffer from sleep disorders, drug dependency or alcoholism;

• (h) persons who are less than 18 years old;

• (i) pregnant women.

• 4.2.Manufacturers shall apply the following safety measures where relevant:

• (a) avoidance of unauthorised access to the device (for example by means of key switch or code) and unintended use of the device (for example by means of dual control of energy emission);

• (b) minimisation of stray magnetic fields;

• (c) minimisation of the risk of accidental emission;

• (d) emergency stop function (for example emergency stop switch);

• (e) automatic deactivation where maximum acceptable output is reached;

• (f) automatic deactivation where maximum acceptable duration of exposure is reached;

• (g) automatic deactivation in case of overexposure due to a combination of output and duration;

• (h) videos with instructions on how to safely use the device made available on the internet;

• (i) provision of appropriate training accessible to users on safe and effective use of the device;

• (j) information for the user on the correct functioning of the device and the actual mode of operation through acoustic or optical means in standby mode, in operating mode and in case of loss of full skin contact during the procedure.

• 4.3.Devices shall contain controls for the application time, the waveform and the energy applied. They shall contain automatic alarms for cases where a critical value is reached for one parameter (for example energy level, duration of use) or for combination of parameters. Critical values shall be set below the maximum acceptable values.

Information for safety

• 5.The instructions for use and, if possible, the label, shall indicate the performance that the consumer can expect from the use of the device as well as the risks arising from its use. The intended performance shall be described in such a way that the consumer understands which non-medical effects can be expected from the use of the device (for example enhanced intelligence or improvement in mathematical ability).

• 6.Information on warnings, precautions and side-effects shall cover:

• (a) specific risks for persons listed in Section 4.1;

• (b) risks for persons with active implantable or active body-worn medical devices;

• (c) risks for persons with metallic passive medical devices or other metallic objects present on or inside the body;

• (d) information about how to deal with over-exposure to energy;

• (e) information on how to deal with psychological disturbances.

7. Instructions for use

• 7.1.The instructions for use shall indicate clearly how electrodes and magnetic coils are to be placed on the head. If the exact placement cannot be indicated, the instructions for use shall be specific enough to allow correct placement. The risks arising from a wrong placement of electrodes and coils shall be explained as well as potential negative effects on performance.

• 7.2.The instructions for use shall provide information on:

• (a) the duration, intensity and frequency of stimulation and all risks arising from use, including from excessive use;

• (b) the energy delivered, brain area targeted, wave forms and pulse characteristics.

• Unless there is specific evidence for safe use, as provided for in Section 4.1, the instructions for use shall clearly indicate that the device is not to be used on or by the categories of consumers listed in Section 4.1.

• 7.3.The instructions for use shall also clearly indicate that the device is not to be used in case of open wounds or rashes, or swollen, red, irritated, infected, or inflamed areas or skin eruptions, where components of the device will come into contact with these areas.

• 7.4.The instructions for use shall list all possible direct and indirect risks to the consumer undergoing brain stimulation and to the user by interaction of the electric currents, magnetic fields or electromagnetic fields generated by the brain stimulation device with metallic passive implanted medical devices and other metallic objects present on or inside the body as well as with active implantable medical devices (for example pacemakers, implanted cardioverter-defibrillators, cochlear implants and neural implants) and active body-worn medical devices (for example neural stimulation devices and medication infusion devices). This shall include information on conduction of electric current, reinforcement of internal electric fields, heating or displacement of metallic implants such as electrodes, stents, clips, pins, plates, screws, braces, or other metallic objects such as shrapnel or jewellery.

• 7.5.Where the device is intended or expected to be applied on the consumer by a professional user, the instructions for use shall contain a requirement for the user to provide the consumer with a copy of the annex provided for in Section 7.7 before the consumer is treated with the device;

• 7.6.The instructions for use shall contain the internet address where the videos with instructions made available in accordance with Section 4.2, point (h) can be found.

• 7.7.Where the device is intended or expected to be applied on the consumer by a professional user, the instructions for use shall contain an annex, written in a language commonly understood by lay persons and in the form that is easy to be handed over to all the consumers. The annex shall contain:

• (a) the information listed in Section 12.1, points (a), (b) and (c), of Annex I;

• (b) the statement “The users received appropriate training on the conditions to safely use the device.”, where relevant;

• (c) information on when and how to report undesirable side-effects to the manufacturer.

[^E0001]: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117 5.5.2017, p. 1).