En esta reunión del 17 de septiembre se han revisado las especificaciones comunes de obligada aplicación para productos de anexo XVI que se espera sean publicadas a primeros de 2022, entrando pues en aplicación en verano 2022.
Los productos del grupo 5 del anexo XVI del MDR son:
5. Equipos que emiten radiación electromagnética de alta intensidad (por ejemplo, infrarrojos, luz visible y ultravioleta) destinados a su uso en el cuerpo humano, con inclusión de fuentes coherentes y no coherentes, monocromáticas o de amplio espectro, tales como láseres y equipos de luz pulsada intensa para rejuvenecimiento de la piel, eliminación de tatuajes, depilación u otros tratamientos dérmicos.
Os ponemos aqui copia de trabajo confidencial del texto actualizado de las CS anexo 6 :
ANNEX VI
Scope
1. This Annex applies to high intensity electromagnetic radiation (e.g. infra-red, visible light and ultra-violet) emitting equipment intended for use on the human body, including coherent and non-coherent sources, monochromatic and broad spectrum, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair removal or other skin treatment as listed in Section 5 of Annex XVI to Regulation (EU) 2017/745.
For the purposes of this Annex, skin resurfacing includes skin rejuvenation. For the purposes of this Annex, tattoo removal includes removal of permanent make-up. For the purposes of this Annex, other skin treatments include, but are not limited to non-medical treatment of nevi flammei, haemangioma, teleangiectasia, spider veins, pigmented skin areas, and scars that are not injury within the meaning of the second indent of point (1) of Article 2 of Regulation (EU) 2017/745. Accordingly, this Annex applies to devices intended to treat acne scars, it does not apply to devices for other acne treatment. This Annex does not apply to sunbeds used for tanning of the skin or equipment using infrared optical radiation to warm the body or parts of the body.
Definitions
2. For the purpose of this Annex, the following definitions apply:
(1) “device for professional use” means a device that is intended to be used in a healthcare or otherwise controlled professional environment by professionals having proven qualification in the safe and effective use of the device;
(2) “device for home use” means a device that is intended to be used in private environments, meaning not in a controlled professional environment, by lay persons.
Risk management
3. When applying the risk management process established in Annex I to this Regulation, among risks associated with the device, manufacturers shall analyse the specific risks listed in Section 4 and, where relevant, adopt the specific risk control measures listed in Section 5.
4. Specific risks
4.1. Manufacturers shall take into account the following aspects and related risks: (a) various skin types and the degree of tanning of the skin;
(b) age of the consumers;
(c) possibility of concurrent medical treatments or drug misuse;
(d) reduced reaction to harm caused by local or systemic anesthesia;
(e) exposure to other light sources.
4.2. Manufacturers of devices using high intensity electromagnetic radiation shall analyse, eliminate or reduce as far as possible the following risks:
(a) burns;
(b) formation of scars/keloids;
(c) hypo-/hyperpigmentation;
(d) accelerated aging of skin;
(e) allergic/chemical skin reaction (e.g. to colour pigments of tattoos or make-up);
(f) alterations of melanoma, nevi, herpes, possible delay of disease diagnoses (e.g. melanoma, endocrine diseases);
(g) reactions in case of possible drug intake or use of cosmetics;
(h) possible reactions to sun or sunbed exposure;
(i) erythema, mostly temporary and/or occasionally persistent;
(j) purpura resulting from bleeding from small blood vessels;
(k) crusting;
(l) edema;
(m) blistering;
(n) inflammation, folliculitis, skin infection;
(o) eye damage, including retina and cornea;
(p) prickling or feeling of heat;
(q) dry skin and itching due to shaving or combination of shaving and light treatment;
(r) excessive pain;
(s) paradoxical hypertrichosis (increased growth of hair after treatment);
(t) unintended release of radiation;
(u) ignition, explosion or production of fumes.
5. Specific risk control measures
5.1. Manufacturers shall apply the following safety concepts to devices for professional use:
(a) avoidance of unauthorized access to or unintended use of the devices (e.g. by means of key switch or code or dual control of energy emission);
(b) display of the characteristics of the emitted optical radiation for the purpose of permanent surveillance and recording (documentation) of the emission through the device in addition to what is stipulated in Section 16.2 of Annex I to Regulation (EU) 2017/745;
(c) continuous contact controls and an interlock system ensuring that the device works only in case of full skin contact with the emitting area of the device;
(d) avoid overexposure for each session of the treatments by particular measures (e.g. automatic deactivation);
(e) where the wavelength of the radiation emitted is less than 1200 nm, integrated skin tone sensor with the sensor assessing the skin patch of or near to the area to be treated and allowing emission output only if skin pigmentation is suited for treatment and there is continuous full skin contact after skin tone analysis;
(f) implementing specific risk control measures to avoid overexposure by repeated treatment sessions or repeated treatments;
(g) low energy preset;
(h) optimized limitation of pulse energy and pulse duration (exposure time on tissue) and a combination of these two parameters with the wavelength range;
(i) optimized limitation of treatment areas (spot sizes) also taking into account parameters referred to in point (h);
(j) minimization of scattered radiation;
(k) minimization of the risk of accidental emission;
(l) emergency stop function (e.g. emergency stop switch);
(m) for devices for hair removal: minimization of UV radiation, to be achieved (e.g. by using appropriate high quality band edge filter);
(n) devices intended to deliver a permanent change of the appearance shall not be used on persons who are less than 18 years old;
(o) information for the user on the correct functioning of the device and the actual mode of operation by means of acoustic and/or optical means in standby mode, in operating mode and in case of loss of full skin contact during the procedure;
(p) instruct the user to protect nevi or lesions during the procedure.
5.2. Devices shall not emit radiation outside the wavelength range between 180 and 12000 nm.
5.3. Devices for home use are only permitted for the purpose of hair removal.
5.4. Manufacturers of devices for home use shall implement the risk control measures listed under Section 5.1 for devices for professional use unless established otherwise in this Regulation. In addition, they shall set limits for the duration of exposure and include automatic deactivation to avoid risk of overexposure. Manufacturers shall also provide instructional videos on how to safely use the device made available on the internet wherever possible.
5.5. Manufacturers shall provide, together with the device, appropriate eye protection for users, consumers and any other person likely to be exposed to the radiation due to reflection, misuse or mishandling of the emitting device. The eye protection for the user has to ensure that the eyes are protected from intense pulsed light or laser light whilst not impairing accurate and safe treatment.
5.6. If the eye protection is intended to be used several times, it must be ensured that the protection level is not negatively impacted by necessary cleaning or disinfecting procedures during the whole lifetime of the device. Accordingly, the necessary cleaning and disinfecting instructions shall be provided.
5.7. Manufacturers shall provide training accessible to users. Such training shall cover the conditions for safe and effective use of the device, the management of any associated incidents and the identification and subsequent processing of reportable incidents.
Information for safety
6. Instructions for use
6.1. The instructions for use shall contain:
(a) the minimum radiation intensity, duration and frequency of use necessary to trigger the desired effect;
(b) the maximum and the recommended radiation intensity, duration and frequency of use;
(c) the minimum interval between several applications at the same location;
(d) the risks arising from excessive use;
(e) the radiation intensity, duration and frequency which triggers a sharp increase of risks, if any;
(f) the radiation intensity, duration and frequency beyond which there is no more additional performance;
(g) the pulse energy, fluence, wavelength range [nm], pulse duration [ms], pulse profile(s);
(h) the maximum admissible treatment spot size [cm2];
(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 recommendation to provide the consumer with a copy of the annex required by the Section 6.10.
6.2. With the exemption of devices for hair removal where excessive hair is not attributed to a medical condition, the manufacturer shall clearly convey the necessity that the users and the consumers need to undergo a medical consultation including a diagnostic examination of the skin areas intended for the treatment. Manufacturers shall warn not to treat any consumers prior to obtaining documentation from such consultation, especially when any doubt can subsist regarding the consumer’s ability to receive such treatment.
6.3. The instructions for use shall clearly describe requirements for cleaning and maintenance. For devices intended for professional use, these shall include the measurement of light energy density and required controlled measures, performed at least annually.
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, these also include:
(a) the description/listing of appropriate accessories or conditions of other products used in the procedure;
(b) the safety precautions to be taken which include, but are not limited to, 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 under any circumstances 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 (IPL) 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 to enable them to ensure that professional users are evaluating consumers. This includes, but is not limited to consumers’ suitability for treatment with devices falling under these common specifications and counselling them appropriately and adequately with respect to risks and potential outcomes of the procedure, taking into account the consumers’ health history and concomitant medications. 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.
6.10. The instructions for use of devices for professional use shall contain an annex, written in a language commonly understood by lay persons and easy to be handed over to all the consumers.
The document shall contain:
(a) information listed in points from (a) to (1)(c) of Section 12.1 of the Annex I;
(b) the statement “The users received appropriate training on the conditions to safely use the device”, where relevant;
(c) a recommendation to undergo a medical consultation, including a diagnostic examination, of the skin areas intended for the treatment.