EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2020) XXX  draft  
ANNEXES 1 to 7  
 
ANNEXES  
to the  
Commission Implementing Regulation (EU) ../..  
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   EN 1  EN ANNEX  I 
Scope  
1. This Annex applies to all the devices covered by Annexes II to VII.  
Risk Management  
2. General requirements  
2.1. Manufacturers shall establish a nd docum ent responsibilities , operative modalities  and 
criteria for the execution of the following steps of the risk management process:  
(a) risk management planning;  
(b) identification of hazards and risk analysis;  
(c) risk evaluation;  
(d) risk control  and evaluation of residual risks ; 
(e) risk management review ; 
(f) production and post -production  activities . 
2.2. Top-level management of the manufacturer s shall ensure  that adequate resources  are 
allocated  and that competent personnel is assigned for risk management. Top -level 
management shall define and document  a policy for establishing criteria for risk 
acceptability . Such policy shall  take into account  the generally acknowledged state of 
the art, known concerns related to safe ty expressed by interested parties and  shall  
include the principle that risks are to  be eliminated or reduced as far as possible by 
means of control measures without adversely affecting the overall residual risk.  Top-
level management shall ensure that the risk management process is executed and 
shall review its e ffectiveness and suitability at planned intervals.  
2.3. The personnel responsible for performing risk management tasks shall be 
appropriately qualified. They shall have, where that is needed for  the perform ance of  
tasks , proven and documented knowledge of and experience in using the particular 
device , equivalent devices without an intended medical purpose  or analogous devices  
with a medical purpose , as well as knowledge of the technologies involved and risk 
management te chniques.  Evidence of qualification and competences  of personnel , 
such as education, training, skills and experience, shall be documented.  
An analogous device with a medical purpose shall be understood as the same device 
with a medical purpose or a medical  device for which equivalence to the same device 
with a medical purpose has been demonstrated by the manufacturer in accordance 
with Section 3 of Annex XIV to Regulation (EU) 2017/745  of the European 
Parliament and of the Council1. 
2.4. The results of the risk management activities , including the reference to the device , 
the reference to the persons who carried out the activities  and the dates of execution 
of such activities , shall be recorded.  For every identified hazard, the records shall 
provide traceability to the results of risk analysis, risk evaluation, risk control and 
evaluation of residual risks.  
                                                 
1 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 Regulatio n (EC) 
1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117 5.5.2017, p. 1).  EN 2  EN 2.5. Based on the results of the risk management process, manufacturers shall define the 
categories of users and consumers that are to be excluded from the use of t he device 
or for which special conditions of use have to be applied.  A consumer shall be 
understood as a natural person on whom a product  without an intended medical 
purpose is intended to be used.  
2.6. Throughout the entire lifecycle of a device , the manufac turer shall establish  a system 
to ensure a continuous systematic update of the risk management process  in relation 
to that device .  
3. Risk management planning  
3.1. Risk management planning documents shall  include : 
(a) references and  description of the device , includi ng its parts and components ; 
(b) a list of the activities  to be performed in each step of the risk management 
process , their scope  and the actions  for the verification of completion and 
effectiveness of the risk control measures ; 
(c) a specification of  the life cycle phases of the device covered by each activity 
included in the plan;  
(d) a specification of  responsibilities and authorities  for the execution of the 
activities , for the approvals of the results  and for the risk management review ; 
(e) a specificatio n of criteria for risk acceptability  based on the policy  referred to 
in Section 2.2; 
(f) a specification of  criteria for the collection of relevant information from the 
production and from the post production phases and for the use of such 
information to review and update, if necessary, the risk management results.  
3.2. The criteria for risk acceptability shall include the description of the criterion for the 
acceptability of t he overall residual  risk. The method for the evaluation of the overall 
residual risk shall be defined  and documented .  
3.3. In d efining the criteria for risk acceptability  in accord ance with  the principles 
established by the policy  referred to in Section 2.2, manufacturers shall consider that 
all risks are to  be eliminated or reduced as far as possible.  Risks of death or 
irreversible serious injury or serious deterior ation of the  state of health, including 
risks  related to surgical intervention, shall be accepted only if eliminated or reduced 
as far as possible. If the undesirable side -effects are of transient nature and do not 
require medical or surgical intervention to prevent life -threatening illness or 
permanent impairment of a body function or permanent damage to a body structure, 
residual risks may be considered as being acceptable. If one or more of the 
conditions  laid down in  this Section  is not  met, the manufac turer shall provide a 
justification explaining the reasons for the acceptability of the risks.  
4. Identification of h azards and risk analysis  
4.1. Documents  for the identification of hazards and risk analysis  shall:  
(a) include a d escription of the device , its intended use and the reasonably  
foreseeable misuse;  
(b) list the qualitative and quantitative characteristics that could affect the safety of 
the device;  EN 3  EN (c) list the known and the foreseeable hazards associated with the device , its 
intended use , its characterist ics and its  reasonably foreseeable misuse , when 
used in both normal and fault conditions;  
(d) list the hazardous situations resulting from the consideration of the foreseeable 
events for each identified hazard;  
(e) include the qualitative or quantitative terms and  descriptions, or the 
categorization, for the  estimat ion of  the severity and the probability of 
occurrence of harms . 
(f) for each hazardous situation, list the estimated severity and probability of 
occurrence of harms and the resulting estimation of risks.  
4.2. The description of the intended use of the device shall include information on the 
intended purpose , the part of the human body or type of tissue interacted with , the 
categories of users and consumers, the use environment and the treatment  procedure.  
4.3. In the risk analysis manufacturers shall take into account the specificities of various 
user and consumer groups.  This includes considering whether the user is a  healthcare 
professional  or a lay person.  In the case of  a lay person distinction shall be made 
betwee n a person without qualification for the use of the device and  a person who 
uses a device in the context of his or her professional activities, and who, although 
not being a healthcare professional, ha s a proven qualification for the use of the 
device . It shall be  presumed  by the manufacturer  that all th ose user and consumer  
groups have access to the device unless the device is only sold directly to healthcare 
professionals.  
4.4. Manufacturers shall consider clinical data as one of the  source s of information for  the 
risk analysis and for the estimat ion of the  severity and the probability of occurrence 
of harms . 
4.5. Where  due to  the nature of the devices or for ethical reasons data on the probability 
of occurrence of harm cannot  be generated, manufacturers shall estimate the risk on 
the basis of the nature of the harm and a worst case estimate of the probability of the 
harm occurring. In the technical documentation manufacturers shall provide evidence 
justifying the reason for no t providing data on the probability of occurrence of harm.  
4.6. The description of the scope for the risk analysis shall be recorded.  
5. Risk evaluation  
5.1. For any hazardous situation, m anufacturers shall evaluate the estimated risks and 
determine whether  the risk s are acceptable in accordance with  the criteria referred to 
in Section 3.1, point (e). 
5.2. Where the risk is not acceptable , risk control shall be performed.  
5.3. Where the risk is acceptable , risk control is not needed  and t he final estimated risk  
shall be considered as a residual risk.  
6. Risk control and evaluation of residual risks  
6.1. Documents for risk control and evaluation of residual risks  shall  include : 
(a) a list of the implemented risk control measures and the evaluation of the ir 
effectiveness ; 
(b) a list of the residual risks  after completed  implementation o f the risk control 
measures;  EN 4  EN (c) the evaluation of acceptability for residual risks and for the overall residual 
risk, in accordance with the  criteria referred to in Section 3.1, point (e); 
(d) the verification  of the effects of the risk control measures . 
6.2. Risk c ontro l measure s to be implemented by the manufacturer shall be selected from  
the following categories of risk control options : 
(a) inherent safety ensured by design;  
(b) inherent safety ensured by manufacturing;  
(c) protective measures in the device  or in the manufacturing process ; 
(d) information for safety  and, where appropriate, user training . 
Manufacturers shall select risk control measures in the priority order from points (a) 
to (d). Measures from a risk control option shall not be implemented unle ss the 
measures from the previous option  cannot be implemented or , where implemented, 
have not resulted in the risk acceptability . 
6.3. Manufacturers shall ensure that the information  for safety  is not limited to the 
instruction for use or to the label , but also available by other means . Information 
integrated in the device itself that the user cannot disregard and public information 
easily accessible to the user shall be considered. Where appropriate , user training  
shall be considered . The information shall be presented  taking into account the 
degree of understanding of users and consumers  as referred to in Section  9. 
6.4. Risk control measures shall be taken even if the perf ormance of the device is thereby 
reduced as long as the main function of the device is maintained.  
6.5. When deciding on risk control measures, manufacturers shall verify whether the risk 
control measures generate new harm, hazards or hazardous situations and w hether 
the estimated risks for previously identified hazardous situations are affected by 
those measures. The reduction of a risk shall not increase one or several other risks 
so that the overall r esidual risk could be increased.  
7. Risk management review  
7.1. Documents for risk management review shall include  a review before the release for 
commercialisation of the device. The review shall ensure that:  
(a) the risk management process has been carried out in accord ance with  the risk 
management planning documents  referred to in Section 3.1; 
(b) the overall residual risk is acceptable and the risks have been eliminated or 
reduced as far as possible;  
(c) the system to c ollect and review information on the device from the production 
and the post -production phases is  implemented.  
8. Production and post -production  activities  
8.1. Documents for production and post production  activities  shall:  
(a) specify the system to collect and review  information on the device from the 
production and the post -production phases ; 
(b) list the sources of publicly available information on the device, on  equivalent 
devices without an intended medical purpose or on analogous devices  with a 
medical purpose ; EN 5  EN (c) specify the criteria to evaluate the impact of the information collected on the 
results of previous risk management activities  and the consequent actions on 
the device . 
As part of the system to collect and review information on the device from the post -
production phases , manufacturers shall consider clinical data from the post market 
surveillance, and, where applicable, clinical data from the summary of safety and 
clinical performance  referred to in Article 32  of Regulation (EU) 2017/745  or the 
post-market clinical follow -up referred to in Part B of Annex XIV to that Regulation . 
8.2. For the specification of  the criteria to evaluate the impact of the information 
collected , the manufacturer shall consider:  
(a) hazards or hazardous situations  that have not been identified previously ; 
(b) hazardous situations for which the risk is no longer acceptable;  
(c) whether  the overall residual risk is no longer  acceptable . 
Any impact of the information collected affecting the effectiveness and suitability of 
the risk management process shall be considered as an input for the top -level 
management review referred to in Section  2.2. 
8.3. For the specification of  the consequent actions on the results of previous risk 
management activities, manufacturers shall consider  an update of the former  results 
of the risk management activities to : 
(a) include new hazards or hazardous situations and evaluate the related risks;  
(b) re-evaluate hazardous situations, residual risks and the overall residual risk no 
longer acceptable;  
(c) establish the need for actions in relation to  the devices already made available 
on the market.  
8.4. Manufacturers sh all take account of any changes in risks identification, analysis and 
evaluation which could arise from new data or changes in device use environment.  
Information for safety  
9. When providing information for safety  referred to in Section 6.2, point (d), and on 
the risks linked to the use of the device  referred to in Section s 11.3, point (c) and 
12.1, point (c), manufacturers shall take into account:  
(a) the different degree of understanding of users and consumers, with parti cular 
emphasis on  devices intended to be used by lay person s; 
(b) the work environment where the device is intended to be used, especially in 
case of use outside a medical or otherwise professionally controlled work 
environment.  
10. If the device is intended by th e manufacturer only for a non -medical purpose, 
information supplied with the device shall not bear any clinical benefit claim or 
statement.  If the device is intended by the manufacturer for a medical and non -
medical purpose, information provided for the no n-medical purpose shall not bear 
any clinical benefit claim or statement.  
11. Label  EN 6  EN 11.1. Devices which are intended by the manufacturer for a non -medical purpose only 
shall be labelled “for non -medical use only”.  
11.2. Devices which are intended by the manufacturer for a medical and non -medical 
purpose shall be labelled “also for non -medical use”.  
11.3. If feasible , manufacturers shall specify on the label:  
(a) the information regarding the categories of users and consumers referred to in 
Section 2.5; 
(b) the expected performance of the device;  
(c) the risks arising from the use of the device.  
12. Instructions for use  
12.1. The instructions for use shall include:  
(a) the information regarding the categories of users and consumers referred to in 
Section 2.5; 
(b) a description of the expected performance of the device, in such a way so that 
the user and the consumer understands which non -clinical benefit can be 
expected from the use of the device;  
(c) a description of the residual risks  of the device , including their control 
measures, presented in a clear and easily understandable way so that the 
consumer can make an informed decision on whether to be treated with it, have 
it implanted or otherwise use it;  
(d) the expected lifetime or the expected resorption period of the device and any 
necessary follow -up; 
(e) reference to any harmoni sed standard  and common specifications applied . EN 7  EN ANNEX II 
Scope  
1. This Annex applies to contact lenses listed in Section 1 of Annex XVI to Regulation 
(EU) 2017/745. Contact lenses containing tools, such as antenna  or microchip, 
contact lenses which are active devices and other items intended to be introduced 
into or onto the eye are not covered by this Annex . 
Risk management  
2. 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 3 of this Annex and, where relevant  
to the device , adopt the s pecific risk control measures listed in Section 4 of this 
Annex . 
3. Specific risks  
3.1. Manufacturers shall analyse  and eliminate  or reduce as far as possible the risks 
linked to the following aspects:  
Design and manufacturing  
(a) the shape of the device, in particular in view of avoiding irritation by edges or 
sharps, disconnection  or dislocation from th e cornea, wrinkling or folding,  
equality of pressure on the cornea related to positioning;  
(b) the selection of raw materials for lens, for surface treatments and, if relevant, 
for lens storage solutions in view of biological safety, biocompatibility, 
chemical and biological contaminants as wel l as permeability of oxygen and 
compatibility with lens storage solutions;  
(c) biological safety and biocompatibility of the final product, with its packaging 
and storage solution, including consideration of at least the aspects of 
cytotoxicity, sensitization, irritation, acute systemic toxicity, subacute toxicity, 
implantation, sterilization residues and degradation products, extractable and 
leachable substances . Where the cumulative contact duration is expected to 
exceed  30 days, aspects of acute systemic toxicity, subacute toxicity  and 
genotoxicity  shall also be considered ; 
(d) microbi ological properties, including bioburden, microbiological 
contamination of the final device, residual bacterial endotoxins, sterility, 
contact lens disinfection and preservation;  
(e) appropriateness of the primary packaging in terms of keeping the lens sterile , 
permanently covered by storage fluid and avoiding degradation of the product, 
for example  by leaching of container or cover materials, by intrusion of 
microbial contaminations;  
(f) the effect of long -term storage and the conditions of storage on the stabilit y and 
properties of the lens;  
Distribution chain  
(g) lack of pre -use testing of suitability of lens wearing performed by 
ophthalmologist , speciali sed optician  or qualified contact lens specialis t; EN 8  EN (h) lack of expertise of distributors outside the classic optician distribution chain 
with regard to both the selection of appropriate lenses and their use , storage 
and safe transport;  
(i) lack of expertise of distributors outside the classic optician distribution chain 
with regard to safety or handling advice to the users;  
User-related hazards/risks  
(j) lack of experience with and training on the use of contact lenses of certain 
uses;  
(k) identification of contra -indications under which contact lenses shall not be 
used;  
(l) possible reduced availability to the cornea of tear film and oxy gen; 
(m) lack of hygiene, such as failure to wash and dry hands prior to users placing, 
using and removing lenses resulting in possible infection, severe inflammation 
or other diseases of the eye;  
(n) possible vision hindrance and reduced transmission of light;  
(o) any possible factors that could cause deterioration of eye sight such as 
coloration, lack of precise fitting to the eye’s surface and lack of correction;  
(p) identification of any non-medical conditions under which contact lenses are not 
be used . Conditions to b e considered shall include driving, piloting or 
operating heavy machinery  and water -based activities such as showering, 
bathing and swimming;  
(q) increased risk of eye damage if the lenses are worn extensively ( for example  
for long periods, consecutive multipl e use);  
(r) increased risk of eye damage if lenses are still worn when eye redness and 
irritation occur;  
(s) the effect of duration of use on any of the risks mentioned above;  
(t) possible misuse of the primary packaging as containment for storage between 
several uses ; 
(u) for multiple use contact lenses, risks linked to re -use and irregular re -use by the 
same consumer ; lack of familiarity of consumers  with emergency measures in 
case of any undesirable side -effects . 
4. Specific risk control measures  
(a) The field of vision shall not be reduced by the lens, including in case of 
reasonably foreseeable dislocation or imprecise placing. The lens shall permit 
transmission of sufficient light for adequate visibility under any condition of 
use. 
(b) All materials of the lens and the inner sid e of its primary packaging, including 
its storage solution, shall be biocompatible, non -irritating and non -toxic. In 
addition, the substances  used for colouring  of or printing on  the contact lenses 
shall not leach under the intended conditions of use.  
(c) Lens es and the inner side of their primary packaging, including its storage 
solution shall be sterile  and non -pyrogenic . If in contact with the eye, the 
storage liquid shall not injure the cornea, eye and the surrounding tissue.  EN 9  EN (d) Lenses  shall be designed so as not to compromise the health of the cornea, eye 
and surrounding tissue . Lens features such as low oxygen permeability, 
imprecise placing, dislocation, sharp edges, abrasion, unequal mechanical 
pressure distribution  shall be conside red. 
(e) As regards  lenses for multiple use, the manufacturer shall either provide 
effective maintenance liquids and means for cleaning and disinfecting together 
with the lens sufficient for  the entire lifetime  of the lens , or indicate  the 
required maintenance  liquids and means for cleaning and disinfecting. The 
manufacturer shall  also either provide or indicate  any other  equipment or tools 
for the maintenance and cleaning of the lenses for multiple use . 
(f) As regards  lenses for multiple use, the manufacturer shal l validate the 
maximum number of re -uses and maximum duration of use ( for example  in 
hours per day and/or number of days).  
(g) Manufacturers shall consider whether  eye drops  need to be used  to compensate 
for dryness. Where such eye -drops are needed, manufactur ers shall define  
criteria to demonstrate  their suitability;  
(h) Manufacturers shall establish a procedure for the identification of any 
undesirable side -effects by the user and how to deal with them, including 
reporting to the manufacturer of such undesirable  side-effects;  
(i) The instructions for use and the label shall be designed and written in a manner 
so that they can be understandable by a lay person and that enabl es a lay person 
to use the device  safely . 
Information for safety  
5. Label  
5.1. The outer packaging int ended to be provided to users  shall contain the following 
indications : 
(a) where  devices are intended for single use, in addition to the internationally 
recognized symbol, in bold font of largest used size  on the label  the text “For 
single use only”;  
(b) indication of the dimensions of the lens (outer diameter of the lens and base 
curve radius);  
(c) the recommendation to read the instructions for use.  
6. Instructions for use  
6.1. The instructions for use shall contain:  
(a) in bold font of largest used size  in the instruct ions the text: “For single use 
only”, in addition to the internationally recognized symbol, where  devices are 
intended for single use;  
(b) a warning “Used lenses shall not be used by other persons ”; 
(c) the indication of the dimensions of the lens (outer diameter of the lens and base 
curve radius);  
(d) the indication of the materials of  the lens, including its surface and colouring 
pigments;  EN 10  EN (e) the indication of water content and oxygen permeability;  
(f) an indication of the possible effect of incorrect storage conditions on the 
quality of the product and maximum storage time;  
(g) instructions on what to do in case of  displacement ; 
(h) hygiene measures prior to use (for example  washing and drying hands), during 
use and after use;  
(i) a warning “Do not contaminate lenses with make -up or ae rosols.”;  
(j) a warning “Do not clean lenses with tap water.”;  
(k) for multiple use lenses, a detailed description of the cleaning  and disinfecti on 
procedure , including the description of the necessary equipment , tools  and 
solutions, which shall be named in detai l; a description of  required storage 
conditions ; 
(l) for multiple use  lenses , the maximum number of re -uses and maximum 
duration of use(s) ( for example  in hours per day and/or number of days);  
(m) where the use of eye drops is recommended, a description  of suitable eye drops 
and the description on how to use them ; 
(n) listing of contraindications under which contact lenses are not to be used. Such 
a list shall include: dry eyes (inadequate tear fluid), use of eye medication, 
allergies, inflammation or redness in  or around the eye, poor health affecting 
the eye such as cold and flu, previous medical intervention which may 
adversely affect the use o f the device,  any other systemic illness affecting the 
eye; 
(o) a warning: “Do not use whilst participating in traffic -related situations ( for 
example  driving, riding a bike), operating machinery or whilst undertaking  
water -related activities  such as showering, bathing and swimming.”;  
(p) a warning: “Avoid activities where possible vision hindrance and reduced 
transmi ssion of light create a risk.”;  
(q) a statement regarding increased risk of eye damage in case of  continuous wear  
when eye redness and irritation occur;  
(r) a warning “Do not use after date of expiry.”;  
(s) a clear indication of the maximum wearing time;  
(t) a warning “Do  not use lenses beyond maximum wearing time.”;  
(u) a warning “Do not use lenses during sleeping periods”;  
(v) a statement on the increased risk of eye damage if the lenses are worn 
extensively ( for example  multiple re -uses);  
(w) a warning “Do not use in excessively dr y or dusty environments.”;  
(x) a warning “Do not re -use the primary packaging as containment for storage 
between uses.”, where primary packaging is  not intended by the manufacturer 
for such use ; 
(y) a warning: “Do not re -use the storage solution.”;  EN 11  EN (z) a list of risks  linked to ocular health associated with lens wear, as identified by 
risk analysis, including , if applicable,  reduced availability to the cornea of 
water and oxygen (oxygen transmissibility);  
(aa) a list of possible undesirable side -effects, their probability o f occurrence and 
their indicators;  
(bb) instructions on how to deal with complications, including emergency measures;  
(cc) an instruction “Remove the lens immediately in case of:  
– irritation or eye pain such as stinging, burning, itching, foreign body 
sensation;  
– reduced comfort when compared with previous wearing of an identical 
lens;  
– unusual secretions or excessive tear -flow,  
– redness of the eye,  
– severe or persistent dryness,  
– reduced or blurred vision linked to the use of the lens.  
If any of these symptoms continue after removal of the lens, contact a  qualified 
healthcare professional , such as an ophthalmologist,  or an optometrist, 
authorised  by national law  to treat such symptoms . The continu ation  of these 
symptoms might indicate a more serious condition.”;  
(dd) information on how to report undesirable side -effects to the manufacturer.  EN 12  EN ANNEX III 
Scope  
1. This Annex applies to products intended to be totally or partially introduced into the 
human body through surgically invasive means for the purpose of modifying the 
anatomy , listed in Section 2 of Annex XV I to Regulation (EU) 2017/745. Tattooing 
products, piercings and products intended to be totally or partially introduced into the 
human body through surgically invasive means for the purpose of modifying the 
fixation of body parts are not covered by this Annex . This Annex does not apply to 
active implantable devices . 
Risk management  
2. When carrying out  the risk management process provided for in Annex I to this 
Regulation, as part of the analysi s of risks associated with the device, manufacturers 
shall consider the specific risks listed in Section 3 of this Annex  and, where relevant  
to the d evice , adopt the specific  risk control measures listed in Section 4 of this 
Annex . 
The risk analysis shall include a section on risks that are related  to the specific non -
medical intended purpose of introducing th e device into the human body through 
surgically invasive means, taking into account specific characteristics of potential 
users and consumers of the device.  
3. Specific risks  
3.1. Manufacturers shall t ake into account  the following  aspects and related risks:  
(a) physical and chemical characteristics and full composition of the implant;  
(b) the selection of raw materials in view of biological safety, biocompatibility and 
chemical and biological additives or cont aminants;  
(c) for resorbable devices, resorption and life -time in the body, indicating the half -
life and the end of the resorption;  
(d) biological safety and biocompatibility of the final product, including 
consideration of at least the aspects of cytotoxicity, sensitisation, irritation, 
material mediated pyrog enicity,  acute systemic toxicity , subacute toxicity, 
subchronic toxicity, chronic toxicity , genotoxicity, carcinogenity, implantation, 
sterili sation residues and degradation products, extractable and leachabl e 
substances;  
(e) microbiological properties, including bioburden, microbiological 
contamination of the final device, residual bacterial endotoxins and sterility;  
(f) the specific anatomical location for which clinical and other data support the 
use of the device;  
(g) consumer specific factors ( for example  previous accidents, special conditions, 
age restrictions);  
(h) potential interactions with magnetic field, (for example  heating  related to 
magnetic resonance imaging ); EN 13  EN (i) use of accessories ( for example  delivery instruments  designed to be specifically 
used with the device for the implantation procedure) and their compatibility 
with the implant;  
(j) time interval between implantations, where applicable.  
3.2. Where appropriate, manufacturers shall in particular analyse , eliminate or  reduce as 
far as possible the following risks:  
(a) microbiological contamination;  
(b) presence of manufacturing debris;  
(c) implantation procedure risks (including use errors);  
(d) implant failure ( for example  rupture, unintended degradation);  
(e) implant dislodgement and migration;  
(f) asymmetry;  
(g) implant visibility through the skin;  
(h) implant deflation  and wrinkling;  
(i) gel bleeding  and leakage;  
(j) sweating and silicone migration;  
(k) local inflammation  and swelling;  
(l) regional swelling or lymphadenopathy;  
(m) capsule formation and contracture;  
(n) discomfort  or pain;  
(o) hematoma;  
(p) infection  and inflammation;  
(q) superficial wound;  
(r) wound dehiscence;  
(s) extrusion of implant  and interruption of wound healing;  
(t) scarring  and scar hyperpigmentation and hypertrophy;  
(u) nerve injury;  
(v) seroma;  
(w) compartment pressure problems  and compartment syndrome;  
(x) limitation in cancer diagnosis;  
(y) over-sized implants;  
(z) vascular damage;  
(aa) breast implant associated anaplastic large cell lymphoma ( BIA-ALCL) ; 
(bb) granuloma, including siliconoma where applicable;  
(cc) necrosis.  
4. Specific risk control measures  EN 14  EN (a) Devices shall be sterile and non-pyrogen ic. Where implants are supplied non -
sterile with the intention to be sterilised before use, adequate instruction for 
sterilisation shall be provided.  
(b) The safe use of the device shall be supported by clinical and oth er data 
considering the anatomical location.  
(c) Long -term data shall be collected to evaluate the presence of non -degradable 
substances originating from the devices.  
(d) Presence of substances referred to in Section 10.4.1 , points  (a) and (b) , of 
Annex I to Regul ation (EU) 2017/745 shall be evaluated independently of their 
concentration.  
(e) Manufacturers shall provide training on the implantation and safe use of the 
device.  That training shall be accessible to users . 
Information for safety  
5. Label  
5.1. The label shall conta in: 
(a) in bold font of largest used size  on the label  the text: “Only to be implanted in 
an appropriate medical environment by appropriately trained medical doctors 
who are qualified or accredited in accordance with national law.”;  
(b) a clear indication that dev ices are not to be used in persons who are less than 
18 years old ; 
(c) the overall qua litative composition of the product.  
6. Instructions for use  
6.1. The instructions for use shall contain : 
(a) on top in bold fonts of largest used size in the instructions of use the tex t: 
“Only to be implanted in an appropriate medical environment by appropriately 
trained medical doctors who are qualified or accredited in accordance with 
national law.”;  
(b) a clear indication that devices are not to be used in persons who are less than 
18 years old ; 
(c) the recommendation for the user to consider any previous procedures, 
accidents, conditions, medications or other simultaneous treatments of the 
consumer that may affect the procedure ( for example  skin diseases, traumas 
and auto -immune diseases);   
(d) the instruction for the user to consider any specific risks that may be applicable 
to activities of the consumer ( for example  profession, sports or other activities 
regularly performed by the consumer);  
(e) a comprehensive list of contra -indications. This li st shall include  keloid scars;  
(f) the overall qualitative and quantitative composition of the product;  
(g) the recommendation for the user o n a post -administration monitoring time in 
order to identify any potential undesirable side -effects;  EN 15  EN (h) an indication of the appropriate time interval betwe en treatments, where 
applicable;  
(i) a requirement  for the user to provide the consumer  with a copy of the  annex  
provided for in  Section 6.2 before the consumer is treated with the device.  
6.2. 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) to (e),  of Annex I;  
(b) a list of all residual risks and potential side -effects, including those commonly 
related to surgery such as bleeding, potential drug interactions and the risks 
associated with anaesthesia, in a clear way;  
(c) information on how to report undesirable side -effects, information on device 
removal, information on when to contact a healthcare professional;  
(d) details on volume and size of the device ; 
(e) the statement “The users received appropriate training on how to safely use the 
device .”, where relevant . EN 16  EN ANNEX IV 
Scope  
1. This Annex applies to substances, combinations of substances, or item s intended to 
be used for facial or other dermal or mucous membrane filling by subcutaneous, 
submucous or intradermal injection or other introduction, excluding those for 
tattooing, listed in Section 3 of Annex X VI to Regulation (EU) 2017/745.  This 
Annex  only applies to the means for introduction into the body , for example  syringes  
and dermarollers , where th ey are prefilled with the substances, combinations of 
substances or other items  listed in Section 3 of Annex XVI to Regulation (EU) 
2017/745.  This Annex  does not apply to a ctive devices . 
Risk management  
2. 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 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. Manufacturers shall take into account the following aspects and related risks:  
(a) physical and chemical characteristics of the device ; 
(b) the selection of raw materials in view of biological safety, biocompatibility and 
chemical and biological additives or contaminants;  
(c) biological safety and biocompatibility of the final product, including 
consideration of at least the aspects of cytotoxicity, sensiti sation, irritation, 
material mediated pyrog enicity,  acute systemic toxicity, subacute toxicity, 
subchronic toxicity, chronic toxicity, genotoxicity, carcinogenity, implantation, 
sterili sation residues and degradation products, extractable and leachable 
substances;  
(d) resorption and life -time in the body, indicating the half -life and the end of the 
resorption, including the possibility of metaboli sation ( for example  enzymatic 
degradation of the filler material such as hyaluronidase for hyaluronic a cid 
fillers);  
(e) microbiological properties, bioburden, microbiological contamination of the 
final device, residual bacterial endotoxins and sterility;  
(f) the specific anatomical location  of injection or introduction ; 
(g) consumer specific factors ( for example  previous and current treatments 
(medical and surgical), age restrictions, pregnancy, breast -feeding);  
(h) if applicable, risks related to the use of local anesthetic, either as part of the 
product or stand -alone;  
(i) for non -resorbable devices, the risk associate d with the removal of the device;  
(j) aspects associated with the use of the device , includ ing: 
– injection technique ; EN 17  EN – means of injection ( for example  rollers, catheters or needles) ; 
– maximum quantity injected depending on location and applied technique ; 
– possible  repeated injections ; 
– force required to administer the product ; 
– product temperature;  
– transfer of the product  (for example  from a vial to a syringe) . 
3.2. Where appropriate, manufacturers shall analyse , eliminate or  reduce as far as 
possible the following risks:  
(a) microbiological contamination;  
(b) presence of manufacturing debris;  
(c) risks associated with the procedure to inject or otherwise introduce the device 
(including use errors);  
(d) migration of the device;  
(e) device visibility through the skin;  
(f) unintended local inflamma tion and swelling;  
(g) regional swelling or lymphadenopathy;  
(h) capsule formation and contracture;  
(i) discomfort  or pain;  
(j) hematoma;  
(k) infection  and inflammation;  
(l) superficial wound;  
(m) interruption of wound healing;  
(n) scarring  and scar hyperpigmentation and hypertrophy;  
(o) nerve injury;  
(p) seroma;  
(q) compartment pressure problems  and compartment syndrome;  
(r) granuloma, including siliconoma where applicable;  
(s) edema;  
(t) vascular damage;  
(u) severe allergic reactions;  
(v) blindness;  
(w) necrosis.  
4. Specific risk control measures  
(a) Devices shall be sterile non-pyrogenic and intended for single use.  
(b) The safe use of the device shall be supported by clinical and other data 
considering the anatomical location.  EN 18  EN (c) Long -term data shall be collected to evaluate the presence of non -degradable 
substances originating fro m the devices.  
(d) Manufacturers shall provide training on the administration and safe use of the 
device.  That training shall be accessible to users.   
(e) Presence of substances referred to in Section 10.4.1 , points  (a) and (b) , of 
Annex I to Regulation (EU) 2017/745 shall be evaluated independently of their 
concentration.  
Information for safety  
5. Label  
5.1. The label shall contain:  
(a) in bold fonts of largest used size  on the label  the tex t: “Only to be administered 
by appropriately train ed healthcare professionals who are qualified or 
accredited in accordance with national law”.  
(b) a clear indication that devices are not to be used in persons who are less than 
18 years old . 
6. Instructions for use  
6.1. The instructions for use shall contain:  
(a) on top in bold font of largest used size in the instructions for use the tex t: 
“Only to be administered by appropriately trained healthcare professionals who 
are qualified or accredited in accordance with national law.”;  
(b) a clear indication that devices are not to be used in persons who are less than 
18 years old ; 
(c) precise and detailed technical information for a good administering practice;  
(d) description of treatment of the most common side -effects, such as overdosing, 
swelling, hardening, nodules and immune r esponses, with the instruction to 
consult a medical professional if needed;  
(e) instructions for users as to how and when new injections can be placed at 
previously injected locations;  
(f) a list of constituents , which specifies:  
– all constituents responsible for t he intended action with specification of 
their molecular weight range, their degree of cross linkage and their 
concentration ; 
– other constituents such as cross linking agents, solvents, anesthesia, 
preservatives;  
(g) the recommendation for the user to consider any previous procedures, 
accidents, conditions, medications or other simultaneous treatments of the 
consumer that may affect the procedure ( for example  skin diseases, traumas 
and auto -immune diseases);  
(h) the recommendation for the user of a post -administrati on monitoring time in 
order to identify any potential undesirable side -effects ; EN 19  EN (i) a requirement  for the user to provide the consumer with a copy of the annex 
provided for in  Section 6.2 before the consumer is treated with the device.  
6.2. 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) to (e) , of Annex I ; 
(b) all residual risks and potential undesirable side -effects listed in a clear way and 
described in a language commonly understood by lay persons. This includes a 
clear declaration on the presence of any substances referred to in Section 10.4.1 
of Annex I to Regulation (EU) 2017/745, heavy metals or other contaminants;  
(c) information on when and ho w to report undesirable side -effects;  
(d) information on when to contact healthcare professional;  
(e) any contra -indications to the procedure ; 
(f) the statement “The users received appropriate training on the conditions to 
safely use the device .”, where relevant . 
In addition, a specific part of th e annex shall be designed to record information on 
the location, the number and the volume of the injections, for each consumer. The 
manufacturer shall recommend the healthcare professional to fill in this specific part.  EN 20  EN 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 i mplantable  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 betwee n 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 f luid 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;  EN 21  EN (h) whether the device is a simple liposuction device, i.e. blunt cannu la 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 the following risks:  
(a) post-operative seroma;  
(b) tissue injury, organ perforation and bleeding;  
(c) post-operative ecchymosis and edema;  
(d) indirect risks, such as the risks caused by the 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, g as 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 the following risks:  
(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;  EN 22  EN (g) body deformity or similar poor aesthetic outcome causing the need for medical 
intervention;  
(h) for lipolysis  devices  that are surgically invasive , the risks link ed 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. 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.  
5.3. Where applicable, manufacturers shall make sure the devices have  the following  
functions : low energy preset, emergency stop  function ( for example  emergency sto p 
switch) , automatic deactivation in case of over -exposure or excessive liposuction, 
respectively.  
5.4. Liposuction  devices , lipolysis devices and lipoplasty devices shall  not be used in 
private environments by lay persons . 
5.5. 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 di sorders,  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 inf ections  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;  EN 23  EN (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 bod y 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:  
(c) hyper - or hypovolaemia;  
(d) bradycardia;  
(e) venous thromboembolism;  
(f) fat embolism;  
(g) infection;  
(h) fluid accumulation;  
(i) skin erythema or panniculitis;  
(j) 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 lipopla sty are not  reliable method s for weight 
reduction. Consideration should be given to exercise and dietary as well as 
lifestyle modification, both as alternative s 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 w arnings  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 EN 24  EN antagonists, non -dihydropyridine calcium -channel blockers, cardiac glycosides, 
and cent rally 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 have extended post -operative 
analgesia ( for example  for 24 hours or more) which may result in reduced 
sensation in the areas infiltrated and therefor e 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 o ne 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 equipm ent and 
emergency drugs used for resuscitation purposes  up-to-date. Medical d octors 
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 tu mescent 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. Th e 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) a recommendation to undergo a medical consultation, including a diagnostic 
examination, of the areas intended for the treatment.  EN 25  EN ANNEX VI 
Scope  
1. This Annex applies to high intensity electromagnetic radiation ( for example  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 treatmen t, 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 m ake-
up. 
For the purposes of this Annex , other skin treatments include non-medical treatment 
of nevi flammei, haemangioma, teleangiectasia, spider veins, pigmented skin areas, 
and scars that are not  injury within  the meaning of Article 2 , point (1), second indent,  
of Regulation (EU) 2017/745.  For example , this Annex applies to devices intended to 
treat acne scars,  but it does not apply to  devices for other acne treatment.  
This Annex does not apply to equipment using infrared optical radiation to warm the 
body or parts of the body  and to sunbeds .  
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 environment or otherwise controlled professional  environment by 
professionals having proven qualification in the safe and effective use of the 
device;  
(1) “device for home use” means a device that is intended to be used in private 
environments, not in a controlled professio nal environment, by lay persons.  
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. 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.  EN 26  EN 4.2. Manufacturers shall analyse , eliminate or  reduce as far as possible the following 
risks:  
(a) burns;  
(b) formation of sca rs and keloids;  
(c) hypo pigmentation and hyperpigmentation;  
(d) accelerated aging of skin;  
(e) allergic/chemical skin reaction ( for example  to colour pigments of tattoos or 
make -up); 
(f) alterations of melanoma, nevi, herpes, possible delay of disease diagnoses ( for 
examp le 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 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 damage to 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 measures  as regards  devices for 
professional use : 
(a) avoidance of unauthorized access to or unintended use of the devices ( for 
example  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 of the emission through the device in 
addition to  the requirements of  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 ance of  overexposure for each session of the treatment by particular 
measures (for example  automatic deactivation ); EN 27  EN (e) where the wavelength of the radiation emitted is less than 1  200 nm,  integra ted 
skin tone 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 
if there is continuous full skin contact after skin tone analysis ;  
(f) measures to avoid  overexposure by repeated treatment sessions or repeated 
treatments;  
(g) low energy preset;  
(h) optimi sed 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 the 
parameters referred to in point (h) ; 
(j) minimi sation of scattered radiation;  
(k) minimi sation of the risk of accidental emission;  
(l) emergency stop  function  (for example  emergency stop switch ); 
(m) for devices  for hair removal : minimi sation of ultraviolet  radiation (to be 
achieved for example  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 yea rs old ; 
(o) information for the user on the correct functioning of the device and the actua l 
mode of operation by means of  acoustic or optical means in standby mode, in 
operating mode and in case of loss of full skin contact during the procedure;  
(p) instruct ion o f the user to protect nevi or lesions  during the procedure . 
5.2. Devices for home use shall not emit radiation outside the wavelength range between 
180 nm and 1 200 nm. 
5.3. Devices for home use may only be used for the purpose of hair removal.  
5.4. Manufacturers of devices for home use shall implement the risk control measures 
listed in Section 5.1 unless otherwise provided in this Regulation. In addition, 
manuf acturers of devices for home use  shall set limits for the duration of exposure 
and include automatic deactivation to avoid risk of overexposure. Manufacturers 
shall also make available  on the internet , videos with instructions on how to safely 
use the devi ce. 
5.5. Together with the device m anufacturers shall provide 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 negati vely impacted by necessary cleaning or disinfecting 
procedures during the whole lifetime of the device. 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.  EN 28  EN For devices for home use , videos  with instructions  shall be considered as training 
accessible to  users . 
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 radia tion 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 t he 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 l ifetime 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 incre ase 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 clearly convey 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  
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 EN 29  EN include the measurement of light energy density and required controlled measures, 
performed at least annually.  
For devices for professional use, the ma nufacturer 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 
ventilati on; 
(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 re flection, 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 i ncreased 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 epile psy, 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, t he 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 co nsumers’ suita bility 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. The instructions for use sha ll contain  the internet address where the videos with 
instructions made available in accordance with Section 5.4. can be found . EN 30  EN 6.11. The instructions for use of devices f or 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) a recommendation to undergo a medical  consultation, including a diagnostic 
examination, of the skin areas intended for the treatment.  EN 31  EN 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 direc t 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 An nex 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 managemen t 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 ri sks: 
(a) the incorrect placement of electrodes and coils may result in failed 
performance 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 substa nces 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 r isks 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 an alyse , eliminate or  reduce as far as possible the following 
risks:  
(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);  EN 32  EN (d) transient auditory threshold shift or tinnitus ; 
(e) long-term side-effect changes of the brain functioning ; 
(f) risks linked to the long -term effects of repeated stimulation;  
(g) risks linked to t he use of the device in certain environments highly stimulating 
or attention demanding;  
(h) atypical or other idiosyncratic effects;  
(i) specific risks arising at the interface between electrodes and skin;  
(j) indirect risks, such as the risk of electromagnetic inter ference 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) risks associated with devic e usage after  intake of alcohol and/or soft -drugs 
and/or central nervous system stimulating substances/pharmaceuticals;  
(l) risks 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 u ndergoing 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 per son’s natural 
perception regardless of whether th ose 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 unauthori sed 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) minimi sation of stray magnetic fields;  
(c) minimi sation of the risk of accidental emission;  EN 33  EN (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 d uration;  
(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 devi ce 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.  
Information for safety  
5. The instructions for use and, if possible, the labe l, 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 benefits can be e xpected 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. I f 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 performanc e. 
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.  EN 34  EN 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 o r 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 
undergoi ng 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 insid e 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 
instruct ions 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 .