ANNEX VSupplementary provisions
ANNEX V Scope 1. This Annex applies to equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty, listed in Section 4 of Annex XVI to Regulation (EU) 2017/745. This Annex does not apply to active implantable devices. Definitions 2. For the purpose of this Annex, the following definitions apply: (1) “liposuction” means the surgical removal of localised subcutaneous fat deposits by aspiration; (2) “liposuction devices” means devices intended by the manufacturer to be used for the purpose of liposuction; (3) “lipolysis” means the localised destruction of fat deposit; (4) “lipolysis devices” means devices intended by the manufacturer to be used for the purpose of lipolysis; (5) “lipoplasty” means the modification of body contours by removal of excess fat; (6) “lipoplasty devices” means devices intended by the manufacturer to be used for the purpose of lipoplasty. Risk management 3. When carrying out the risk management process provided for in Annex I to this Regulation, as part of the analysis of risks associated with the device, manufacturers shall consider the specific risks listed in Section 4 of this Annex and, where relevant to the device, adopt the specific risk control measures listed in Section 5 of this Annex. 4. Specific risks 4.1. Where relevant as regards the device in question, manufacturers shall take into account the following aspects and related risks: (a) the volume of adipose tissue which may be removed or, in the case of lipolysis, destroyed and the expected metabolic effect, including the metabolisation of released tissue components, taking into account the probable different characteristics of the person undergoing treatment; (b) the minimum time lapse between subsequent procedures; (c) the anatomical location of the use of the device; (d) the cannula type, for example the diameter and nature of the tip of the cannula; (e) the amount of suction which will be applied; (f) the use and subsequent metabolisation of infiltrative fluid with a justification for the choice of fluid and its composition; (g) the type of liposuction which the device is intended to provide, for example dry or wet, and the type of anaesthetic; (h) whether the device is a simple liposuction device, i.e. blunt cannula suction, or whether it incorporates any other mechanism of action, for example the use of laser energy or ultrasound; (i) the age distribution, gender and body-mass-index of the population to which the clinical data or other sources of data relate; (j) the way in which energy is emitted. 4.2. Where relevant as regards the device in question, manufacturers shall analyse, eliminate or reduce as far as possible risks related to the following hazards or harms: (a) post-operative seroma; (b) tissue injury, organ perforation and bleeding; (c) post-operative ecchymosis and edema; (d) interference with active implantable or active body-worn medical devices and with metallic passive medical devices or other metallic objects present on or inside the body; (e) thermal injury; (f) mechanical injuries, including those caused by unintended cavitation, and corresponding side-effects; (g) inflammation. 4.3. For liposuction devices, in addition to the risks listed in Section 4.2, manufacturers shall analyse, eliminate or reduce as far as possible the following risks: (a) haemorrhage; (b) perforation of abdominal viscera, thorax or peritoneum; (c) pulmonary embolism; (d) bacterial infections such as necrotizing fasciitis, gas gangrene and sepsis; (e) hypovolemic shock; (f) thrombophlebitis; (g) seizures; (h) risks related to local anaesthetic use: consideration should be given to lidocaine-induced cardiotoxicity or lidocaine-related drug interactions for tumescent liposuction. 4.4. For lipolysis devices, in addition to those risks listed in Section 4.2, manufacturers shall in particular analyse, eliminate or reduce as far as possible risks related to the following hazards or harms: (a) burns to incision sites and overlying tissue; (b) other harmful effects of the internal or external local discharge of energy; (c) over-exposure; (d) neurovascular and local tissue injury, including reduction in cutaneous sensory nerve function; (e) remodelling of collagen that may lead to neoformations; (f) reorganisation of the dermis, with reference to reticular dermis; (g) body deformity or similar poor aesthetic outcome causing the need for medical intervention; (h) for lipolysis devices that are surgically invasive, the hazards linked to the types and sizes of incision. When complying with requirements of this section, manufacturers shall take account of the nature of the tissue and its hydration status. 5. Specific risk control measures 5.1. All materials coming into contact with the body shall be biocompatible, non-irritating, and non-toxic when used in accordance with the instructions for use. 5.2. Invasive parts of the devices shall be sterile and pyrogen-free before use. 5.3. Lipolysis devices shall include controls for the application time, the waveform, the energy applied and the temperature reached on or in the body. The controls shall include simultaneous visual and audible automatic alarms for cases where a critical value is reached for one parameter (for example temperature, energy and pressure level and duration of use) or for a combination of parameters. 5.4. Where applicable, manufacturers shall make sure the devices have the following functions: low energy preset, emergency stop function (for example emergency stop switch), automatic deactivation in case of over-exposure or excessive liposuction, respectively. 5.5. Liposuction devices, lipolysis devices and lipoplasty devices shall not be used in private environments by lay persons. 5.6. Manufacturers shall provide training to users on safe and effective use of the device. Information for safety 6. Instruction for use 6.1. The instructions for use shall contain a comprehensive list of contra-indications for the consumer. It shall include the following contra-indications: (a) coagulant disorders, being treated with anticoagulant medications; (b) uncontrolled hypertension; (c) diabetes mellitus; (d) phlebitis and vasculitis; (e) cancer or tumours; (f) extreme obesity (body mass index above 40); (g) pregnancy; (h) vascular fragility; (i) recent surgery (6 weeks); (j) skin infections and open lesions; (k) varicose veins in the area of treatment; (l) medical conditions, such as heart, lung, or circulatory system disease; (m) age less than 18; (n) incapability to understand the consequences, implications and risks of the medical procedures (for example liposuction, lipolysis, lipoplasty) where the devices are used; (o) elevated body temperature (pyrexia). In addition to the contra-indications listed in the first subparagraph, for lipolysis devices employing radiofrequency electric currents or electromagnetic fields, the list shall contain the following: (a) any metallic passive medical device or other metallic object present on or inside the body; (b) any active implantable or active body-worn medical device. 6.2. The instructions for use shall list the body parts on which the device cannot be used. 6.3. The instructions for use shall contain a comprehensive list of adverse effects for the consumer. This list shall include the following adverse effects: (a) hyper- or hypovolaemia; (b) bradycardia; (c) venous thromboembolism; (d) fat embolism; (e) infection; (f) fluid accumulation; (g) skin erythema or panniculitis; (h) contour irregularities. 6.4. The instructions for use shall contain a comprehensive list of warnings. This list shall include the following warning: “Liposuction, lipolysis and lipoplasty are not reliable methods for weight reduction. Consideration should be given to exercise and dietary as well as lifestyle modification, both as alternatives to liposuction and lipolysis and in order to maintain any reduction in adipose tissue which these procedures may achieve. Devices have not been validated for the treatment of clinically diagnosed obesity and therefore should not be used for such purposes.”. 6.4.1. In addition to the warning referred to in Section 6.4, for liposuction devices, the instructions for use shall contain the following warning: “The volume of blood loss and endogenous body fluid loss may adversely affect intra and/or postoperative hemodynamic stability and the consumer’s safety. The capacity of providing adequate, timely fluid management is essential for the consumer’s safety.”. 6.4.2. In addition to the warnings referred to in Sections 6.4 and 6.4.1, for liposuction devices that may use a tumescent fluid, the instructions for use shall contain the following warnings: (a) “Careful consideration shall be given to consumer suitability with respect to medication which has the potential to cause bradycardia or hypotension as this has been reported as the cause of death in a number of consumers undergoing tumescent liposuction. Consumers taking drugs such as beta-adrenergic antagonists, non-dihydropyridine calcium-channel blockers, cardiac glycosides, and centrally acting alpha-adrenergic agonists shall be subject to very careful consideration as deaths have been reported due to bradycardia and hypotension. The procedure has to be preceded by a medical consultation which has to be documented and during which chronic disease and drugs taken by patient need to be considered.”; (b) “Consumers shall be warned that they may experience extended post-operative analgesia (for example for 24 hours or more) which may result in reduced sensation in the areas infiltrated and therefore consumers shall be warned to protect themselves from injury.”. 6.4.3. In addition to the warning referred to in Section 6.4, for lipolysis devices, the instructions for use shall contain the following warning: “Liver or cardiovascular dysfunction, such that the transient release of glycerol or free fatty acid, may be associated with increased risk.”. 6.5. For liposuction and lipolysis devices, the instructions for use shall contain the following warning: “Devices intended for invasive use shall only be used in an appropriate medical environment by appropriately trained medical doctors who are qualified or accredited in accordance with national law. The medical doctor who carries out the procedure shall be assisted by at least one medical doctor or allied health professional who is qualified or accredited in accordance with national law. All staff involved in the procedure shall be trained and shall keep their knowledge of basic cardiac life support and in the checking of equipment and emergency drugs used for resuscitation purposes up-to-date. Medical doctors performing the procedure shall also be trained in advanced cardiac life support. The medical doctor or allied health professional responsible for anaesthetic management shall ensure appropriate monitoring of the consumer both during the procedure and after it. With respect to tumescent liposuction, appropriate post-procedure monitoring shall be in place as lidocaine levels have been found to rise for up to 16 hours post-delivery.”. 6.6. The instructions for use shall contain the requirement for the user to provide the consumer with a copy of the annex provided for in Section 6.7 before the consumer is treated with the device. 6.7. 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) 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 areas intended for the treatment.