Isocèle Médical

Regulatory Information

SUBJECT: Draft Implementing Regulation relating to the common features and application of classification rules for non-medical devices.

PERSONS CONCERNED: Regulatory Affairs and Quality Managers.

COMPANIES CONCERNED: Medical Device Companies marketing medical devices.

Regulatory CONTEXT

EU Regulation 2017/745 defines the provisions applicable to non-medical devices in appendix XVI.

In contrast to the medical devices, defined in article 2, paragraph 1, of EU Regulation 2017/745, the devices listed in appendix XV1 are only intended for aesthetic or non-medical purposes. As a result, to guarantee an appropriate reduction of the risks during their use, the latter must comply with the set of requirements described in the draft of this Implementing Regulation.

Appendices I to VI set out the specific requirements for each product group concerned:

Appendix I: non-corrective contact lenses.
Appendix II: products intended to be totally or partially inserted within the human body by invasive surgical means with a view to modifying the anatomy or fixing anatomical parts, with the exception of tattoo and piercing products.
Appendix III: substances, combinations of substances or items intended for use as facial, dermal or mucosal fillers by subcutaneous, submucosal or intradermal injection or any other means of insertion, except those intended for tattooing.
Appendix IV: equipment intended to reduce, remove or destroy fat tissue, such as those intended for liposuction, lipolysis and lipoplasty.
Appendix V: equipment emitting high-intensity electromagnetic radiation and intended for use on the human body in the wavelength range from 180 nm to 20,000 nm.
Appendix VI: devices intended for transcranial alternating current stimulation, transcranial direct current stimulation, transcranial magnetic stimulation and transcranial random noise stimulation.

ANALYSis

MAIN PROVISIONS OF THE IMPLEMENTING REGULATION:

Non-medical device manufacturers must follow the risk assessment process set out in Appendix I of EU Regulation 2017/745 in conjunction with the provisions of this Implementing Regulation.

The active device classification rules set out in sections 6 and 7.9 of Appendix VIII of EU Regulation 2017/745 are applicable to non-medical devices.

Manufacturers must evaluate and describe in their technical documentation and instructions for use the likelihood of occurrence and severity of harm, if applicable using qualitative and quantitative terms.

Where there is no data on the likelihood of occurrence of harm, manufacturers must explain the reasons for this in the technical documentation.

For the reduction of risks set out in Appendix I Points (4) (b) and 5 (b) of EU Regulation 2017/745, manufacturers must take into account the degree of understanding of consumers and users with regard to the risks linked to use of the device to be able to effectively reduce the risks.

The non-medical devices listed in Appendix XVI of EU Regulation 2017/745 must be labelled “for non-medical purposes”.

The clinical evaluation of the safety and performance of the device relies on the clinical data providing a sufficient level of clinical evidence. The evaluation of the acceptability of residual risks must be based on this data.

Manufacturers must explain in the technical documentation that the devices are intended to function as described in the information provided with the devices.

appendices :

APPENDIX I

This appendix concerns non-corrective contact lenses (Appendix XVI – 1 of EU Regulation 2017/745).

Risk assessment

During the risk assessment process defined in Appendix I of EU Regulation 2017/745 and referred to in articles 5 and 6 of this Implementing Regulation, manufacturers must analyse and minimise “the specific risks” and implement “the specific risk management measures” listed in this appendix.

Specific risks

Manufacturers must analyse and reduce the risks linked to the following:

Design and manufacturing

Shape of the device, in particular to avoid irritation,
Selection of raw materials for the lens and surface, in terms of biocompatibility and chemical and biological contaminants,
Biocompatibility of the end product with its packaging and storage solution,
Microbiological contamination of the end product,
Adequacy of the primary packaging to maintain sterility,
Effect of long-term storage and storage conditions on the stability and properties of the lens.

Distribution chain, inform the user on:

Typical absence of testing before use by an ophthalmologist or specialist optician,
Lack of expertise outside the traditional distribution chain, in relation to the selection and use of lenses, their safe storage and transport,
Given their method of distribution, possible lack of safety or handling instructions for users from non-corrective contact lens distributors.

Associated dangers / risks to the user:

Lack of experience and training of some users,
Identification of contraindications for use of the lenses,
Reduction of the tear film and in oxygen to the cornea,
General lack of hygiene of users during insertion, use and removal,
Possible visual disturbance and reduction in light transmission,
Deterioration of eyesight due to colour, lack of specific adjustment to the surface of the eye and lack of correction,
Identification of (non-medical) situations, such as driving, flying or use of heavy machinery, during which contact lenses must not be used,
Increased risk of eye damage if lenses are overused,
Increased risk of eye damage if use continues despite eye redness and irritation,
Effect of duration of use on the aforementioned risks,
Inappropriate use of primary packaging for storage between several uses,
For reusable lenses, risks linked to reuse, i.e. improper use by the same user,
lack of familiarity with emergency measures in case of adverse events.

Specific risk management measures – Safety requirements

Field of vision must not be reduced by the lenses,
Colouring agents used must not leach,
Lens materials and the internal face of their packaging, including the storage solution, must be biocompatible, non-irritant and non-toxic,
The lenses, the internal face of their packaging, including the storage solution, must be sterile and pyrogen-free. In case of contact with eyes, this storage liquid must not injure the cornea, eyes or surrounding tissue,
As the lenses are not generally adjusted by an optician, they must be designed in such a way as not to alter the cornea, eye or surrounding tissue.
For multiple use lenses, manufacturers must provide effective maintenance solutions and cleaning and disinfection methods with the lenses covering the service life of the lenses or specify the solutions and cleaning and disinfection methods to use. Manufacturers must test all other accessories and additional items (in Member States), where the lenses are available on the market,
For multiple use lenses, the maximum number of uses and maximum duration of use must be confirmed by the manufacturer,
Manufacturers must take into account the use of eyedrops to compensate for dry eyes. These drops and their compatibility criteria must be identified and described to users / consumers,
Identification of adverse events by the consumer and how they are dealt with, including how to report these events to the manufacturer,
Instructions for use and label of the devices must be designed to be understood by laymen, enabling them to use the devices safely,
Presence of substances referred to in section 10.4.1 of Appendix I of EU Regulation 2017/745 must be evaluated irrespective of their concentration.

Performance

No additional criteria to those mentioned in EU Regulation 2017/745 and Article 9 of this Regulation are required.

Clinical evaluation

The clinical evaluation relates in particular to the elements set out in the paragraphs “Specific risks” and “Specific risk management measures – Safety requirements” of this appendix, as well as those linked to performance.

The duration of the evaluation and monitoring must be sufficient to identify the long-term complications.

Label and instructions for use

Label

The label must contain the following information:

Information on the categories of users who are excluded, as well as any possible contraindications,
Whether the devices are single use,
Information on the dimension (external diameter of the lens and radius of curvature),
Recommendation to read the instructions for use,
Expiry date.

Instructions for use

The instructions for use must use language commonly understood by laymen in text that is easy to read with normal and corrected vision (215 ± 15 lx):

If the devices are single use, in addition to the internationally recognised symbol, the following text in bold type of the maximum size used: “Single use only”,
Warning that lenses must not be used by third parties,
Information on lens dimensions,
Information on raw materials,
Information on water content and oxygen permeability,
Information on the possible effects of inappropriate storage on the quality of the product and its maximum duration,
Illustrated instructions on how to handle the lenses safely,
Instructions on what to do if a lens becomes displaced,
The hygiene measures before, during and after use,
Warning “Do not contaminate lenses with make-up or aerosols”,
For multiple use lenses, the cleaning and disinfection procedures and storage conditions must be described, including the necessary equipment and solutions that must be listed in detail,
List of contraindications. This list must include at least: dry eyes (insufficient tear fluid), use of eye drugs, allergies, eye inflammation or redness, health conditions affecting the eyes, such as cold and flu, prior medical intervention that could alter the device, any other systemic disease affecting the eyes,
Warning: “Do not use the device when undertaking traffic-related activities (driving, cycling, etc.), when operating machinery or when bathing or swimming”,
Warning: “Avoid activities where there is a risk of obstruction of vision or reduction in the transmission of light”,
Increased risk of eye injury if the device continues to be worn despite eye redness or irritation,
Warning “Do not use after expiry date”,
Clear information on the maximum recommended use time,
Warning “Do no use lenses for longer than the maximum recommended use time”,
Warning on the increased risk of eye injury if worn excessively (for example, while sleeping, multiple consecutive uses),
Warning “Do not use in excessively dry or dusty environments”,
Warning: “Do not reuse primary packaging for storage between uses”,
Warning: “Do not reuse storage solution”,
List of risks associated with reduced water and oxygen availability for the cornea,
List of possible adverse events, their likelihood of occurrence and their symptoms,
Instructions on how to deal with adverse events, including emergency measures,
Instruction “Remove lens immediately in case of:
- Eye irritation or pain, such as tingling, burning sensation or itching,
- If lenses feel less comfortable than on previous occasions when identical lenses were worn,
- Unusual secretions or excessively runny eyes,
- Eye redness,
- Severe or persistent dryness,
- Reduced or blurred vision.

If any of these symptoms persist after removing the lens, contact an ophthalmologist. The persistence of these symptoms could indicate a more serious condition.

Information on how to report adverse effects (in Member States where the device is on the market).

Appendix II

This appendix concerns products intended to be totally or partially inserted within the human body by invasive surgical means with a view to modifying the anatomy or fixing anatomical parts, with the exception of tattoo and piercing products. (Appendix XVI – 2 of EU Regulation 2017/745).

Risk assessment

Identical to Appendix I – manufacturers must analyse and minimise “the specific risks” listed and implement “the specific risk management measures”.

Specific risks

For each specific product covered by this appendix, the risk analysis must include a section on the risks concerning only the specific non-medical purpose, taking into account the specific characteristics of potential users and consumers of the product concerned.

During the risk assessment, manufacturers must take into account the following elements and associated risks:

The physical and chemical characteristics and full composition of the implant,
Selection of raw materials in terms of biocompatibility and chemical and biological contaminants,
For resorbable devices, the resorption and lifespan in the body, stating the half-life and end of resorption,
Biocompatibility of the end product, including but not limited to, cytotoxicity, acute systemic toxicity, sub-chronic toxicity, intradermal reactivity, genotoxicity, skin sensitisation, intradermal and subcutaneous implant,
Choice of raw materials in terms of biocompatibility and chemical additives or contaminants,
Microbiological contamination of the end device,
Specific anatomical location in which the clinical and other data justify use of the device,
Factors specific to the patient (for example, previous accidents, specific conditions, age-related restrictions),
Potential interactions with magnetic fields, for example, heating linked to MRI.

If applicable, manufacturers must in particular analyse and reduce the following risks:

Microbiological contamination,
Presence of manufacturing debris,
Risks linked to implant surgery (including, incorrect use),
Failure of the implant (for example, bursting, accidental damage),
Location and movement of implants,
Asymmetry,
Visibility of the implant through the skin.
Implant deflation / wrinkling,
Significant flow of gel / leakage,
Seepage and / or migration of silicone,
Local inflammation / swelling,
Regional swelling (axillary glands),
Capsular formation and contraction,
Discomfort / intense and constant pain,
Haematoma,
Infection / inflammation,
Superficial wound,
Surgical wound,
Implant extrusion / failure of the wound to heal,
Healing of the wound / hyperpigmentation of the scar / hypertrophy,
Nerve damage,
Seroma,
Compartment pressure / compartment syndrome,
Limitation of cancer diagnosis,
Oversized implants.

Specific risk management measures

Devices must be sterile and pyrogen-free. When metal implants are provided unsterilised and must be sterilised prior to use, adequate instructions must be provided.

Safe use of the device must be supported by the clinical and other data, taking into account the anatomical location.

Long-term data must be collected to evaluate the presence of non-degradable substances coming from the devices.

Manufacturers must provide training accessible to users.

The presence of substances referred to in points 10.4.1 a) and b) of Appendix I of EU Regulation 2017/745 must be evaluated irrespective of their concentration.

Performance

No additional criteria to those mentioned in EU Regulation 2017/745 and Article 9 of this regulation is required.

Clinical investigation and evaluation

The clinical evaluation must cover the aspects set out in the paragraphs “Specific risks”, “Specific risk management measures” and “Performance” of this appendix.

The duration of the clinical investigations and monitoring must be sufficient to evaluate the expected duration of performance and identify the long-term complications.

Clinical investigations must include all specific anatomical locations in which the device can be used in accordance with its intended purpose.

Manufacturers must include the surgical intervention to introduce the device into the human body in the clinical evaluations.

Following a clinical evaluations, the changes to the quality of life of recipients must be included, based on a recognised measurement tool.

Label and instructions for use

The label must contain the following information:

In bold type at least average size, the text “Must only be implanted in an appropriate medical setting by duly trained, qualified or approved doctors, in accordance with national regulations”,
Clear instruction that devices must not be implanted into minors,
Full composition of the product.

The instructions for use must contain:

In bold type of the maximum size used, the following text: “Must only be implanted in an appropriate medical setting by duly trained, qualified or approved doctors, in accordance with national regulations”,
Clear instruction that devices must not be implanted into minors,
Instruction for the user to take into account all the consumer’s previous procedures, accidents, conditions or drugs likely to affect the procedure,
Instruction for the user to take into account the specific risks that could apply to the consumer (for example, a profession, sport or other activity regularly practised by the consumer),
Full list of the contraindications. This list must at least include keloid scars,
Full product composition,
Recommendation to the user to take into consideration any procedures, conditions and drugs likely to affect the procedure (for example, skin disease, trauma),
Recommendation to the user of a post-administration surveillance time to identify potential adverse events.

The appendix referred to in article 7 of the Implementing Regulation* contains:

Information that must be provided to consumers in accordance with EU Regulation 2017/745 or the horizontal provisions of this Regulation,
All residual risks and potential side effects, including those generally linked to surgery, such as bleeding, potential drug interactions and risks associated with the anaesthesia, in a transparent manner,
Information on how to report an adverse effect, information on the removal of the device, information on how to contact healthcare professionals,
Volume and size of the device.

Appendix III

This appendix concerns substances, combinations of substances or items intended for use as facial, dermal or mucosal fillers by subcutaneous, submucosal or intradermal injection or any other means of insertion, except those intended for tattooing. However, it does not apply to the insertion devices, such as syringes, derma rollers or other similar products. (Appendix XVI – 3 of EU Regulation 2017/745).

Risk assessment

Manufacturers must analyse and minimise “the specific risks” listed and implement “the specific risk management measures” of this appendix.

Specific risks

During the risk assessment, the following elements and associated risks must be taken into account:

Physical and chemical characteristics of the device,
Selection of raw materials in terms of biocompatibility, chemical and biological additives and contaminants,
Biocompatibility of the end product, including but not limited to, cytotoxicity, local and systemic toxicity, acute intradermal reactivity, genotoxicity, sensitisation, intradermal and subcutaneous implant,
Resorption and lifespan in the body, including metabolization (for example, enzymatic breakdown of filler material, such as hyaluronidase for hyaluronic acid fillers),
Microbiological contamination of the end device,
Specific anatomical location,
Factors specific to the patient (for example, previous or current treatments (medical and surgical), age, weight and breastfeeding restrictions),
Aspects linked to the use of the device, including but not limited to, injection techniques, injection methods such as rollers, catheters and needles, maximum injected quantity depending on the location and technique used and storage or transfer of the product during or subsequent to the following procedures.

Specific risk management measures

Devices must be sterile and pyrogen-free.

Safe use of the device must be supported by the clinical and other data, taking into account the anatomical location.

Long-term data must be collected to evaluate the presence of non-degradable substances coming from the devices.

Manufacturers must train users.

The presence of substances referred to in points 10.4.1 a) and b) of Appendix I of EU Regulation 2017/745 must be evaluated irrespective of their concentration.

Performance

No additional criteria to those mentioned in EU Regulation 2017/745 and Article 9 of this regulation is required.

Clinical investigation and evaluation

The clinical evaluation must cover the aspects set out in the paragraphs “Specific risks”, “Specific risk management measures” and “Performance” of this appendix.

Clinical investigations must include all specific anatomical locations in which the device can be used in accordance with its intended purpose.

The duration of clinical investigations and clinical post-market surveillance must be sufficient to evaluate the duration of the aesthetic effect and identify the long-term complications.

Label and instructions for use

The label must include:

The text “Only to be administered by healthcare professionals duly trained, qualified or approved in accordance with national regulations”.
Clear instruction that devices must not be used on minors.

The instructions must include:

In bold type of the maximum size used, the following text: “Must only be administered by duly trained, qualified or approved healthcare professionals, in accordance with national regulations”,
Clear instruction that devices must not be used on minors,
Precise and detailed technical information on the correct administration practices,
Precise and detailed description of the most common side effects, such as overdose, swelling, hardening and immune reactions,
Clear instructions for users indicating how and when new injections can be placed into locations that have been previously injected,
A list of ingredients specifying:
- The ingredients for the desired concentration, their degree of reticulation and their concentration,
- Other additives such as reticulation agents, solvents, anaesthetics, preservatives.
- Recommendation to the user to take into consideration all the consumer’s previous procedures, conditions and drugs that could affect the procedure (for example, skin disease, trauma),
- Recommendation to the user of a post-administration surveillance time to identify potential adverse events.

The appendix referred to in article 7 of the Implementing Regulation* contains:

Information that must be provided to consumers in accordance with EU Regulation 2017/745 or the horizontal provisions of this Regulation,
All residual risks and potential adverse side effects listed in a transparent manner and described in layman’s terms, including a clear declaration on the presence of substances referred to in article 10.4.1 of Appendix I of Regulation 2017/745, heavy metals and other contaminants,
Information on when and how to report adverse side effects,
Information on when to contact healthcare professionals,
Any other contraindication to the procedure.

In addition, a specific part of the appendix must be used for information purposes. Manufacturers must recommend that healthcare professionals complete this specific part.

appendix IV

This appendix concerns equipment intended to reduce, remove or destroy fat tissue, such as those intended for liposuction, lipolysis and lipoplasty. (Appendix XVI – 4 of EU Regulation 2017/745).

Risk assessment

Manufacturers must analyse and minimise “the specific risks” listed and implement “the specific risk management measures” of this appendix.

Specific risks

During the risk assessment, manufacturers must take into account the following elements and associated risks:

The volume of fat tissue that can be removed or, in the case of lipolysis, destroyed and its expected metabolic effect, given the probable characteristics of the person undergoing treatment,
Minimum time between subsequent procedures,
Anatomical location of use of the device,
Type of cannula, i.e. its diameter,
Fat quantity to be removed,
Infiltration fluid use with an explanation of the choice of fluid and its composition,
Type of liposuction for which the device is intended, for example dry, wet, and the type of anaesthetic,
Whether the device is for simple liposuction, for example, blunt cannula suction, or whether it incorporates any other mechanism, for example, use of laser or ultrasound,
Body mass index of the population to which the clinical data or other sources refer,
Manner in which the energy is emitted, i.e. externally or internally.

If applicable, manufacturers must in particular analyse and reduce the following risks:

Postoperative seroma,
Perforation and bleeding of organs or damaged tissue,
Postoperative bruising and oedema,
Indirect risks, such as those caused by interactions with active implantable or other medical devices and passive medical devices made of metal or other metallic objects present on or inside the body.

For liposuction devices, manufacturers must analyse and reduce as far as possible the following risks:

Haemorrhage,
Perforation of the abdominal viscera, thorax or peritoneum,
Pulmonary embolism,
Bacterial infection, such as necrotising fasciitis, gas gangrene and septicaemia,
Hypovolemic shock,
Thrombophlebitis,
Convulsion,
Risks linked to the use of local anaesthetics, particular attention must be paid to cardiotoxicity caused by lidocaine or drug interactions linked to lidocaine for tumescent liposuction.

For lipolysis devices, manufacturers must analyse and reduce as far as possible the following risks:

Thermal damage, including burns at the incision sites and of the underlying tissue,
Other harmful effects of local internal or external energy discharge of energy,
Overexposure,
Neurovascular and local tissue damage, including the reduction of sensory nerve function in the skin,
Collagen remodelling that can lead to neoformations,
Reorganisation of the reticular dermis,
Body deformation or similar mediocre aesthetic result requiring medical intervention,
For internal lipolysis, risks linked to the types and sizes of incisions.

By meeting the requirements of this section, manufacturers must take into account the nature of the tissue and its state of hydration.

Specific risk management measures

All materials coming into contact with the body must be fully biocompatible, non-irritant and non-toxic when used in accordance with the instructions for use,
Invasive parts must be sterile and pyrogen-free,
Manufacturers must train users,
Lipolysis devices must contain instructions on application times, wave forms, energy applied and temperatures reached on or inside the body. They must contain automatic visual and audio alarms,
If applicable, manufacturers must provide the following functions: low energy pre-set, emergency stop switch, automatic deactivation in the case of overexposure or excessive liposuction.

Performance

Manufacturers must provide proof that fat tissue is actually reduced, removed and destroyed, as claimed in the technical documentation, instructions for use and “performance claims” promotional material.

Clinical evaluation

The clinical evaluation must cover the elements set out in the paragraphs “Specific risks”, “Specific risk management measures” and “Performances” of this appendix.

Label and instructions for use

The instructions for use and, if possible, the label must indicate the performance that the consumer can expect when using the device as well as the associated risks. The expected performance must be described so that consumers can understand what non-medical performance to expect from using the device.

The instructions for use must include a full list of contraindications for the user. Taking into account that each medical consultation is unique and that it is not subject to the clinical judgment of a healthcare professional, it must contain at least the following contraindications:

Coagulation disorders, on anticoagulant drugs,
Uncontrolled hypertension,
Diabetes mellitus,
Phlebitis and / or vasculitis,
Cancer or tumours,
Excessive obesity,
Pregnancy,
Vascular fragility,
Recent operation (6 weeks),
Skin infections / open wounds,
Varicose veins (in the treatment area),
Age below 18 years,
Inability to understand the consequences, implications or risks of the device in conjunction with the necessary medical procedures.

In addition to the contraindications listed above, for lipolysis devices that use radiofrequency electric current or electromagnetic fields, the list must contain the following:

Any passive medical devices made of metal or other metallic object present on or inside the body,
Any active implantable or other medical device.

Instructions for use:

Must list the parts of the body on which the device cannot be used.
Must contain a full list of the adverse effects for the user. This list must include at least the following adverse effects:
Hypervolaemia or hypovolaemia,
Bradycardia,
Venous thromboembolism,
Fat embolism,
Infection,
Fluid build-up,
Cutaneous erythema or panniculitis,
Contour irregularities.

The instructions for use must contain a full list of the warnings. This list must include at least the following:

“Neither liposuction nor lipolysis is a reliable way to loose wright in the long-term. It is necessary to consider exercise and changing one’s diet and lifestyle, both as an alternative to liposuction and lipolysis and in order to maintain the reduction in fat tissue brought about by this procedure. Devices intended for the treatment of clinically diagnosed obesity must not therefore be used for such purposes.”

In addition to the aforementioned warnings, for liposuction devices, the instructions for use must include the following:

“This device must be used with extreme caution by consumers with chronic diseases such as diabetes, heart disease, lung disease, circulatory system disease or obesity.”
“The volume of blood and bodily fluid loss can be detrimental to intraoperative and /or postoperative haemodynamic stability and the consumer safety. The capacity to provide adequate and rapid fluid management is essential for consumer safety.”

In addition, for liposuction devices involving the use of tumescent fluid, the instructions for use must contain:

“Particular attention must be paid to drugs that have the capacity to cause bradycardia or hypotension. This has been reported as a cause of death among a certain number of patients undergoing liposuction. Particular attention must be paid to patients taking drugs, such as beta-adrenergic antagonists, non-dihydropyridine calcium channel blockers, cardiac glycosides and centrally acting alpha-adrenergic agonists. The procedure must be preceded by a medical consultation that must be documented and take into account the chronic diseases and drugs taken by the patient.
“Patients must be informed that they may experience prolonged postoperative analgesia (i.e. for 24 hours or more) that may lead to a reduction in feeling in the area affected and must therefore be warned to protect themselves from injury.”

In accordance with the provisions of this directive, the instructions must contain:

“Liver or cardiovascular dysfunction, such as the transient release of glycerol or free fatty acid, can be associated with an increased risk.”

For liposuction and invasive lipolysis devices, the instructions must contain the following recommendations:

“Devices intended for invasive use” must be used by duly trained healthcare professionals in a medical setting. Liposuction and invasive lipolysis must only be carried out by duly trained, qualified or approved doctors, in accordance with national regulations. Doctors who carry out the procedure must be assisted by a lawyer or qualified or approved healthcare professional, in accordance with national law.
Staff involved in the procedure must be trained in basic cardiac care. Doctors undertaking this procedure must also receive training in advanced cardiac resuscitation techniques.
The doctor or other healthcare professional is responsible for managing the anaesthesia. This involves ensuring that the patient is adequately monitored, during and after the procedure. For tumescent liposuction, appropriate post-procedure monitoring must be provided since lidocaine levels have been observed up to 16 hours after the procedure.”

For lipolysis devices, the instructions must contain the following recommendations:

Devices intended for non-invasive lipolysis must be used by persons appropriately trained in the safe use of the device. Appropriate training involves, in addition to studies, having observed at least 20 procedures and having carried out at least 30 procedures under the supervision of an experienced user of the device.”

Appendix V

This appendix applies to equipment emitting high-intensity electromagnetic radiation and intended for use on the human body in the wavelength range from 180 nm to 20,000 nm for one or more of the following non-medical purposes:

Skin resurfacing (including skin rejuvenation),
Tattoo removal (including the removal of permanent make-up),
Hair removal,
Or other skin treatments.

(Appendix XVI – 5 of EU Regulation 2017/745).

Risk assessment

Manufacturers must analyse and minimise “the specific risks” listed and implement “the specific risk management measures” of this appendix.

Specific risks

During the risk assessment, manufacturers must take into account exposure to other light sources.

During the risk assessment, the following elements and associated risks must be taken into account:

Skin types and degree of skin tanning,
Consumer’s age,
Possibility of simultaneous medical treatments or prescription drug abuse,
Reduction of the reaction caused by local or general anaesthesia.

Manufacturers of devices containing high-intensity fibre optics (electromagnetic photons) must in particular analyse and reduce as far as possible the following risks:

Burns,
Formation of scars / keloids,
Hypo / hyperpigmentation,
Accelerated skin ageing,
Allergic / chemical reaction of the skin (for example to colour tattoo or make-up pigments),
Alteration of melanomas, naevus, herpes, possible delay to disease diagnosis (for example, melanoma, endocrine disorders),
Reactions in case of prescription drug use,
Reactions to sun or exposure in tanning booths,
Erythema, mainly temporary and /or sometimes persistent,
Purpura resulting from bleeding from small blood vessels,
Crusting,
Oedema,
Blisters,
Inflammation, folliculitis, skin infection,
Eye damage, in particular to the retina or cornea,
Tingling or sensations of heat,
Dry skin and itching, due to shaving or a combination of shaving and the light treatment,
Excessive pain,
Paradoxical hypertrichosis (increased hair growth after treatment),
Unintentional radiation poisoning,
In case of lasers: ignition, explosion or vapour production.

Specific risk management measures

Manufacturers must apply the following safety concepts for devices intended for professional use:

Avoid all (unintentional) unauthorised access to devices (for example, by key or code or dual control energy emission switch),
User information on the correct use of the device and its operating mode by acoustic and / or optical means in standby mode, operating mode and in case of total loss of contact with the skin during the procedure,
Display of the characteristics of the optical radiation emitted for permanent monitoring and recording (documentation) of the radiation emitted by the device, in addition to that stipulated in paragraph 16.2 of Chapter II of Appendix I of EU Regulation 2017/745,
Continuous contact controls and a locking system designed to ensure the device can only operate when skin is in full contact with the emission area,
Automatic deactivation in case of overexposure,
The skin sensor and the sensor area must be at least as large as the application window and allow the output of emission only if the skin pigmentation is suitable for treatment (and continuous, full contact of the skin after analysis),
Exposure controls detecting overexposure from repeated treatments,
Low energy pre-set,
Optimised pulsed energy limitation (max. 12 j / cm² for IPL (intense pulsed light); max. 19 j / cm² for laser),
Optimised pulse duration limitation,
Optimised treatment area limitation,
Scattered radiation minimisation,
Accidental emission risk minimisation,
Emergency stop control,
For epilation devices: no UV radiation emission for example, by using an appropriate high-quality band edge filter, which cuts off wave lengths above 500 nm,
Devices intended to bring about a permanent change of appearance must not be used on minors.

Devices for domestic use are only permitted for epilation.

Manufacturers of devices for domestic use must implement the risk management measures listed in this appendix for professional use and take into account the following additional measures:

Automatic emergency stop when maximum acceptable exposure duration is reached.

Manufacturers must provide appropriate eye protection for users, consumers and other persons likely to be exposed to radiation, with the device.

User eye protection must protect the eyes from intense pulsed light or laser light, while allowing precise and safe treatment. Consumer eye protection must be opaque.

If the eye protection is multiple use, it must ensure that the level of protection is not negatively impacted by the cleaning or disinfection procedures required during the service life of the device. As a result, cleaning and disinfection instructions must be provided.

Manufacturers must provide training accessible to users. This training must include the conditions for safe and effective use of the device and the associated incident management, including identification and subsequent reporting.

Performance

When demonstrating the performance of their device, manufacturers must in particular prove that:

The claimed energy output is achieved by the device,
Use of the device achieves the expected performance objectives.

The performance description must include the area of skin to be treated.

Clinical evaluation

The clinical evaluation must cover the elements set out in the paragraphs “Specific risks”, “Specific risk management measures”, and “Performance” of this appendix.

Label and instructions for use

The instructions for use must provide information on:

Minimum intensity of radiation, duration and frequency of use necessary to achieve the desired effect,
Maximum and recommended intensity of radiation, duration and frequency of use,
Minimum interval between applications in the same area,
Risks resulting from excessive use,
Intensity, duration and frequency of radiation leading to a sharp increase in risk, if applicable,
Intensity, duration and frequency of radiation beyond which there is no additional performance,
Pulsed energy (J / cm²), pulse density (J/ kg), wavelength range (nm), pulse duration (ms), pulse profile(s),
Maximum admissible size of treatment point (cm²),
Description of minimum homogeneity of the treatment site,
Description of requirements on the spatial distribution of treatment areas, taking into account that overlapping treated areas must be avoided,
Device safety features,
Expected device service life,
Expected performance stability,
Cosmetic or prescription drug products that interact or are likely to interact with treatment and their description,
Other sources of radiation, such as tanning booths, likely to increase risks,

With the exception of epilation devices, manufacturers must clearly communicate to users and consumers the need to undergo a medical consultation, including a diagnostic examination of the areas of skin to be treated. Manufacturers must recommend users not to treat consumers before having obtained in advance the documents from this consultation, in particular when any doubt exists in relation to consumer’s capacity to receive such treatment.

Instructions for use must clearly describe the cleaning and maintenance requirements,
For professional use devices, these must include the light energy density measurement and the measurement controls that need to be carried out at least once a year,
For devices for professional use, manufacturers must also give the instructions on how to guarantee constant performance and recommend electrical safety tests and maintenance to be carried out at least once a year,
Instructions must clearly describe the operating environment and the conditions in which the device can be used safely.

For devices for professional use, these must also include:

Description / list of appropriate accessories or conditions of other products used in procedures,
Safety measures to take into account, such as use of non-reflective instruments (mirrors must not be used), use of tools with absorbent or scattering surfaces, avoidance of inflammable products and substances and, if applicable, provision adequate ventilation,
Adequate warning notice outside the treatment room.

The instructions for use must highlight the need:

To avoid, in all circumstances, exposure of the eyes to the light emitted,
For users, consumers and other persons likely to be exposed to the radiation (following reflection, misuse or poor use), to wear appropriate eye protection during treatments with devices that use intense pulsed light or laser, in particular, when these need to be used near the face,
The instructions for use must clearly indicate on which consumers, areas of skin, skin types and skin diseases the device must not be used,
The instructions for use must clearly indicate that the device must not be used on areas of skin presenting increased risk of skin cancer, open wounds or erythema, areas that are swollen, red, irritated or inflamed, or skin rashes,
For devices intended to permanently modify appearance, the instructions must specify that these must not be used on minors,
Manufacturers must ensure that all appropriate information is available to healthcare professionals or providers to enable them to guarantee that professional users evaluate clients, including, but not limited to, the suitability of clients to undergo treatment using devices with these common specifications and provision of appropriate and adequate advice to them on the potential risks and results of procedures, taking into account the client’s medical history and associated treatments,
The appendix referred to in article 7 of the Implementing Regulation* must also provide the recommendation to undergo a medical consultation, including (diagnostic) examination of the areas of skin to be treated.

Appendix VI

This appendix applies to devices intended for transcranial alternating current stimulation, transcranial direct current stimulation, transcranial magnetic stimulation and transcranial random noise stimulation.

(Appendix XVI – 6 of EU Regulation 2017/745).

Risk assessment

Manufacturers must analyse and minimise “the specific risks” listed and implement “the specific risk management measures” of this appendix.

Specific risks

When undertaking the risk assessment, particular attention must be paid to the positioning of electrodes, power, wave form, duration and other parameters of the electric current and magnetic fields.

During the risk assessment, manufacturers must take into account the following elements and associated risks:

Inappropriate placement of electrodes and coils can lead to performance failures or unintentional neuronal responses,
Brain stimulation can have very different neuronal responses and therefore unintended effects on different groups of people. Certain groups can be particularly vulnerable: minors, young adults, pregnant women, psychiatric patients, alcoholics and drug addicts,
Presence of active implantable or other devices and passive medical devices made of metal or other metallic objects present on or inside the body can cause specific risks resulting from the application of electrical energy and magnetic fields,
Long-term excessive, frequent and cumulative use can lead to unexpected neuronal effects that can, in certain cases, lead to structural changes in the brain.

Manufacturers must analyse and in particular reduce as far as possible the following risks:

Psychological risks,
Neurological and neuro-toxic risks,
Short-, medium- and long-term cognitive side effects,
Side effects linked to changes in brain function that last several months or more,
Risks linked to the effects of long-term repeated stimulation,
Risks linked to certain very stimulating environments or requiring particular attention,
Atypical effects or other idiosyncratic effects,
Specific risks linked to the interface between the electrodes and the skin,
Indirect risks, such as electromagnetic interference risks or injuries caused by interaction with active implants (pacemakers, automatic defibrillators, cochlear implants and neural implants), active devices (neural stimulation devices and drug infusion devices), passive metallic implants or medical devices worn on the body,
Risks linked to use of the device after consumption of alcohol, recreational drugs, substances that stimulate the nervous system and / or pharmaceutical products,
Risks linked to combined use (use of some / several devices at the same time, targeting the same person or different people) and reasonably foreseeable misuse.

Specific risk management measures

Unless specifically instructed that it is safe, the following categories of consumers must be excluded:

People with a history of epilepsy,
People undergoing pharmaceutical treatment for complaints linked to the central nervous system,
People undergoing therapeutic treatment that modifies the responsiveness of the central nervous system,
Consumers of illicit substances or other substances that modify the natural perceptions of the person, whether commonly considered as therapeutic drugs or not,
People with tumours of the central nervous system,
People with vascular, traumatic, infectious or metabolic brain damage,
People suffering from clinically established lack of sleep, drug addiction or alcoholism,
People under 18 years of age,
Pregnant women.

Manufacturers must apply the following safety concepts, if applicable :

Avoid all (unintentional) unauthorised access (for example, by means of a key or code or dual command energy emission switch),
User information on the correct use of the device and its operating mode by acoustic and / or optical means in standby mode, operating mode and in case of total loss of contact with the skin during the procedure,
Minimisation of stray magnetic fields,
Minimisation of accidental emission risk,
Emergency stop switch,
Automatic deactivation when the maximum acceptable power is reached,
Automatic deactivation when the maximum acceptable duration is reached,
Automatic deactivation in case of overexposure due to a combination of output and duration,
Educational videos on how to use the device safely available on the Internet, wherever possible,
Provide users with appropriate training on the conditions for the safe and effective use of the device.

Devices must include instructions on application time, wave form and energy applied. They must include automatic alarms if critical values are reached for a parameter (for example, energy level, duration of use) or combination of parameters.

Performance

When demonstrating the performance of their device, manufacturers must provide proof that:

The claimed energy output (electrical energy or magnetic field) is achieved by the device,
Use of the device achieves the expected performance objectives

The performance description must include information on the target areas of the brain. This description must also include a list of intended effects of the device, the location of these effects and the stimulation target group.

The performance demonstration for devices aimed at enhancing aptitudes or other human capacities must include tests comparing the aptitudes or capacities before and after stimulation.

Clinical evaluation

The clinical evaluation must cover the elements set out in the paragraphs “Specific risks”, “Specific risk management measures”, and “Performance” of this appendix.

During the initial clinical evaluation and the post-market clinical follow-up (PMCF), manufacturers must pay particular attention to the long-term effects of repeated stimulations.

Label and instructions for use

The instructions for use and, if possible, the label must indicate the performance that the consumer can expect from using the device as well as the possible resulting risks. The expected performance must be described in such a way that the consumer can understand what non-medical benefits can be expected from the device (for example, improved intellectual or mathematical capacities).

The instructions must clearly indicate how the electrodes and magnetic coils must be placed on the head. If the exact positioning cannot be specified, the instructions for use must be quite precise to enable correct positioning. The risks linked to poor positioning of the electrodes and coils must be described, as well as the possible negative effects on performance.

The instructions for use must provide information on:

The duration, intensity and frequency of stimulation and the risks resulting from use, including excessive use,
The energy delivered, target area of the brain, wave forms and characteristics of the pulse.

Unless specifically instructed that it is safe, the instructions for use must clearly indicate that the device must not be used on or by the categories of consumers listed in the Specific risk managements measures of this appendix.

The instructions for use must also clearly indicate that the device must not be used in case of open would or erythema, or on areas that are swollen, red, irritated, infected or inflamed or on skin rashes, when parts of the device come into contact with these areas.

The instructions must list the direct and indirect risks to the consumer and the user resulting from interactions of electric currents, magnetic or electromagnetic fields generated by the stimulation device with passive medical devices made of metal or other metallic objects present outside or inside the body, as well as with active implantable medical device and active medical devices worn on the body (neural stimulation devices and drug infusion devices).

This includes information on the conducting of electric current, strengthening of internal electric fields and heating or displacement of metal implants or other metallic objects.
Information on warnings, precautions and known side effects must at least cover:

Specific risks to persons listed in the part Specific risk management measures,
Risks to those with implantable or other active medical devices,
Risks to persons with passive medical devices made of metal or other metallic objects present outside or inside the body,
Information of how to handle overexposure to energy,
Information on how to handle psychological disturbances,
Information on how to handle other side effects that occur at a rate greater than or equal to 1/100.

The instructions must provide the Internet address where the manufacturer’s educational videos can be found.

If the device is intended for use on consumers by a professional user, the instructions for use must include the appendix set out in article 7 of the Implementing Regulation*.

*If applicable, the instructions must contain an appendix, which lists, in language commonly understood by all layman users, all the information to be provided to the consumer. The instructions for use must include the recommendation that this appendix is sent to the consumer.

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