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CABINET OF MINISTERS OF UKRAINE 
 
DECREE 
of 11/07/2008 No 536 
Kyiv 
 
On approval of the Technical Regulation  
concerning medical products 
  
     In accordance with Article 14 of th e Law of Ukraine “On Standards, Technical 
Regulations and Conformity Assessment Procedures" (3164-15)  the Cabinet of 
Ministers of Ukraine hereby orders: 
 
     1. To approve the Technical Regulation c oncerning medical produc ts (hereinafter – 
the Technical Regulation) that is enclosed.       2. To designate the Ministry of H ealth as a responsible  body for the introduction 
and application of the Tec hnical Regulation as well as supervising the compliance 
with requirements thereof.       3. The Ministry of Health and the Mi nistry of Industrial Po licy together with the 
State Committee for Technical Regulation and Consumer Policy shall develop and 
approve in a month term the road map for the introduction of the Technical 
Regulation.  Prime Minister of Ukraine                                                                Ju. Tymoshenko            2
 
  
APPROVED 
by the Decree of the Cabinet of Ministers of Ukraine 
of 11/07/2008  No 536 
 
TECHNICAL REGULATION 
concerning medical products 
 
General provisions 
 
1. This Technical Regulation determines  the general requirements for medical 
products and the related safety and procedur es to confirm their compliance with said 
requirements.  2.  For the purposes of this Technical Regulation, the following terms shall take 
the following meanings:            1) commissioning – readiness of the medical product for first use and for an 
intended purpose;        2) placing on the market – firs t appearance of medical product, with the 
exception of products for clinical trials, fo r the distribution and/or for use for an 
intended purpose on the Ukrainian market irrespective of whet her this product is 
brand new or modified; 
 
      3) medical products – any tools, apparatus, instruments, gadgets, equipment, 
implants, materials and other devices, incl uding invasive and t hose that are intended 
not for achieving a major medicinal pur pose in a patient but for assisting 
pharmacological, immunobiological or metabolic  remedies to achie ve this objective, 
as well as devices that are used either al one or in combination, including the software 
necessary for their proper f unctioning, as intended by th e manufacturer and with the 
purpose to provide:        preventive measures, diagnosti cs, curing, monitoring and alleviating the 
condition of the patient when it is unwell, injured, disabled as well as compensation 
for organ failure or physical disability;         investigation, replacement or mo dification of the structure (anatomy) of 
organs, tissues or physiological processes;        monitoring the process of conception.       Any equipment that is supplied as a set with medical products and intended to 
be coupled with other external (additional)  equipment shall be considered as an 
integral part of those medical products;   3
      4) custom-made medical produc ts – any medical products manufactured 
specifically following the prescription of a properly qualified physician with specified 
parameters and design and intended to  be used for a specified patient. 
       The abovementioned prescription  could be issued by a different, fully 
qualified person.         Medical products of mass produc tion that require adap tation according to 
specific requirements of a properly qualified physician or any othe r professional user 
are not regarded as custom-made devices;        5) medical products intended for clinical studies – me dical products intended 
for use by a properly qua lified physician during thei r studies in a clinic. 
       During clinical studies any other person who has the necessary qualifications to carry out such studies is equal to the properly qualified physician; 
       6) use as intended – use of me dical products in compliance with the data 
specified by the manufacturer in the identification mark, user manuals and/or advertising materials;        7) kit – items that are not me dical products, but which are specifically 
intended by the manufacturer to be used together with medical products for the 
purpose of their intended use.        Other terms shall be used in th e meaning specified in Laws of Ukraine “On 
Confirmation of Compliance”  (2406-14),  “On Standard isation” (2408-14),  “On 
Accreditation of Conformity Assessmen t Bodies” (2407-14),  “On Standards, 
Technical Regulations and Conformity Assessment Procedures” (3164-15),  “On 
Medicines” (123/96-VR).  3.  Requirements established by this Tec hnical Regulations are mandatory for: 
       manufacturers of medica l products and the corresponding kit; 
       persons – residents of Ukrain e who are authorised by the manufacturer 
(hereinafter the authorised representative);        persons who are responsible for launching medical products on the market or 
putting them into service if the manufacturer or the authorised representative do not exercise activities within Ukraine (hereina fter person who placed  medical products on 
the market or put them into service);        key executive authorities and thei r bodies functioning in technical regulations 
and supervision of the safety  of medical products and corr esponding kits (hereinafter 
key executive bodies);        designated bodies for assessing th e conformity of medical products and kits 
that comply with the requirements established in the Decree of the Cabinet of Ministers of Ukraine of 24/01/2007 No 59 ( 59-2007-p) “On Approval of the Order of  4
the Implementation of Procedure of Appoint ment of Bodies Asse ssing the Conformity 
of Products, Processes and Services to Requirements of Technical Regulations” 
(Ofitsijnyj Visnyk Ukrajiny, 2007, No 6, p. 223) (hereinafter designated bodies). 
 4.  The medical product intended for humans  shall be covered by this Technical 
Regulation, as well as by the Law of Ukra ine “On Medicines” (123/96-VR) according 
to the requirements concerning the medicine.        If the medicine and the medical pr oduct constitute an integral whole and the 
latter cannot be re-used, such product sh all be regulated by th e Law of Ukraine “On 
Medicines” (123/96-VR).  Re quirements established in this Technical Regulation 
cover the parameters of the medical product related to its safety  and effectiveness 
only.        If a substance that constitutes an integral part of a medical product that is capable of effecting an auxi liary action on a patient and if  applied is considered as 
medicine, then it shall comply  with the requirements of th is Technical Regulation.   
 5.  Electromagnetic compatibility of me dical products is regulated by DSTU IEC 
60601-1-2-2001 “Medical El ectrical Equipment”. 
       The Technical Regulation c oncerning confirmation of compliance of 
electromagnetic compatibility does not cover medical products.  6.  Medical products can be divided into classes of potential risks on application: 
I, IIa, IIb and III. Allocation of medical products to one or another class is based on 
the vulnerability of the patient, taking into account the potential risks associated with 
design and manufacturing of those products. This allocation is carried out with the 
help of criteria and rules of classi fication defined in DSTU 4388:2005 “Medical 
Products. Classification with Regards to Potential Risks on A pplication. General 
Requirements”.        If the dispute arises between  the manufacturer and the designated body 
regarding determination of th e class of medical product, th e case shall be resolved by 
the Ministry of Health in compliance with the established order.  7.  Placing medical products that are cove red by this Technical onto the market 
and putting them into service shall be allowe d if this does not e ndanger life and health 
of patients, users and other persons, on condition that the correct installation, servicing and applic ation are provided. 
 8.  The manufacturer or authorised person or the person who put medical 
products into service or placed them on the market shall be held responsible in accordance with legislation for the implemen tation of all procedures of conformity 
assessment established in this Technical Regulation.        Those requirements also concer n legal entities and natural persons who 
assemble,   renovate and/or provide pack aging and marking of  prepared medical 
products.   5
      The abovementioned requirement s do not concern individuals who are not 
manufacturers but assemble and commission medical produc ts that already exist on 
the market following their intended app lication and for specified patients. 
 9.  Compliance of medical products with requirements of National Standards is a 
proof of compliance of products with this Technical Regulation. 
       The list of National Standard s shall include monographs of European 
Pharmacopoeia concerning surgical sutures and interactions between medicines and 
materials that are used in medical products  that contain such medicines. Monographs 
shall be submitted by the State Committee for Technical Regulation and Consumer 
Policy.  10.  Before placing medical products that  have passed conformity assessment 
according to the procedures established by this Technical Regulation on the market or putting them into service, they  shall be labelled with the National Mark of Conformity 
in accordance with the Decree of the Cabine t of Ministers of Ukraine of 29/11/2001 
No 1599 (1599-2001-p) “On Approval of Descri ption and Rules of Application of the 
National Mark of Conform ity” (Ofitsijnyj Visnyk Ukrajiny, 2001, No 49, p. 2188). 
 11.  The presence of the National Mark  of Conformity on medical products 
indicates that the natural person, who has performed labelling or who is responsible 
for the task, has checked and testifies to th e conformity of the medical products with 
the requirements of this Technical Regulati on, that covers thos e products, and that 
products have passed the correct pro cedures of conformity assessment. 
 
12.  If medical products fall within the framework of other te chnical regulations 
that may be labelled with the National Ma rk of Conformity, then medical products 
shall also comply with requirements of t hose technical regulations. Conformity of 
medical products with all such technical re gulations shall be a condition for labelling 
with the Sign.        In the event that one or several technical regulations fo resee the right of the 
manufacturer to choose the method of conf irmation of compliance, labelling with the 
National Mark of Conformity signifies conformity with only those technical 
regulations only that have been used by th e manufacturer. In this case, all documents, 
notifications and inst ructions that are en closed with the medical products shall 
incorporate references to the technica l regulations that have been used. 
 13.  If it has been discovered that the Nati onal Mark of Conformity has been used 
in violation of the requirements of this Technical Regulation, then the manufacturer, 
its authorised representative, or the pers on who placed the medi cal products on the 
market or put them into service shall take actions to cease violat ion, and shall ensure 
that the medical products conform to the re quirements of this Technical Regulation. 
       In the event that the law is viol ated, key executive auth orities shall undertake 
the appropriate action to restri ct or to ban such medical pr oducts from being placed on 
the market or shall withdraw them from the market.   6
14.  If custom-made medical products confor m to the requirements of clause 54 of 
this Technical Regulation, they shall not be labelled with the National Mark of 
Conformity.  15.  If a physician uses any medical product th at is intended for clinical studies and 
conforms to the requirements of Clause 56 of this Techni cal Regulation, they shall not 
be labelled with the Nati onal Mark of Conformity. 
 16.  Exposing of medical products, that di d not meet the conformity assessment 
procedures according to the re quirements of this Technical Regulation, on trade fairs, 
exhibitions, demonstrations of medical produc ts shall be allowed on condition that the 
manufacturer has performed distinct tagging with the information that those products 
cannot be placed on the market or put in to service until they conform to the 
requirements set out in this Technical Regulation.  17.  Following the results of their applic ation, the Ministry of Health will 
undertake continuous monitoring and assessm ent of any information about medical 
products that have been placed on the market  or put into service, and concerning: 
       failure or degeneration of perfor mance levels and/or properties of products, 
any misleading information on the label or in the user manual, that could result or has  
resulted in death or serious health de terioration of patients, users and other 
individuals;        technical or medical reasons for the alteration of performance levels and/or 
properties of products that resulted in  systematic withdrawal thereof by the 
manufacturer. 
       Physicians and public health institutions shall submit the abovementioned information to the Ministry of Health, manufacturers or their authorised representatives in orde r to keep records and to carry out analyses. 
 18.  If it has been revealed that medical products with correct installation, servicing 
and application provided are st ill prone to endanger the health and safety of patients, 
users and other persons, all pos sible actions shall be taken to withdraw such products 
from the market or to ban or to restri ct in compliance with legislation their 
commissioning or placing on the market.  
Requirements concerning the safety of the application of medical products 
 
19.  The application of medical products as  intended shall not pose a risk for the 
health and safety of patients , users and other individuals. 
       It is assumed that any potential ri sks which might be related to the application 
of medical products are tolerable when compar ed to positive effect for the patient, and 
if an improved quality of life and protection of health is provided. 
 20.  Medical products shall correspond to exploitation pr operties, specified by the 
manufacturer, and shall be designed, produced  and packaged so as to function as 
intended by the manufacturer.  7
 
21.  If, during operation, the medical pr oduct under proper application conditions 
or during storage under term s and conditions, specified by  the manufacturer is prone 
to alter its performance levels and/or prope rties that are specified in Clauses 25-44 of 
this Technical Regulation, these parameters and properties shall not deteriorate to a 
degree when clinical state, safety of patient s, users and other indi viduals are subjected 
to risk.  22.  Medical products shall be designed, produced and packaged in the way that transportation, application or storage under conditions specified by the manufacturer do not cause deterioration of thei r parameters and/or properties. 
 23.  Any unwanted side effects of the medical product shall present tolerable 
potential risks on its application when  compared to its intended effect. 
 24.  Technical solutions implemented by the manufacturer in the process of design 
and production of medical products sha ll correspond to the most recent safety 
requirements within the industry.        When making solutions, the manuf acturer shall be predominantly governed by 
the following guidelines:             elimination or maximum reductio n of potential risks on the application of 
medical products;         taking proper protection measures  including alarm signals to avoid potential 
risks that cannot be eliminated on the application of  medical products; 
       informing users about the poten tial risks on the appl ication of medical 
products that exist because proper protection measures cannot be used.  
Requirements for development and pr oduction of medical products 
 
25.  Medical products shall be designed, produced and packaged so as to ensure 
performance levels and/or properties speci fied in clauses 25-50 of this Technical 
Regulation.        In order to achieve this , special care shall be taken in: 
       the selection of ma terials in part of their toxi city and, if required – their 
flammability;        the compatibility of materials w ith tissues, cells and liquids of the human 
body, when taking into account th e intended use of the product; 
       the minimisation of risks of contamination  by medical products and the 
influence thereof on individua ls who take part in the transportation, storage and 
application thereof, taking into acco unt the intended use of the product; 
       the effect on human tissues , for how long and how often it happens;  8
 
      the safety of use in combination wi th materials, substanc es and gases that are 
in contact with medical products under cond itions of their proper application or 
during treatment procedures;        the minimisation of risks arising from substances leaking from the equipment; 
       the minimisation of th e risk of accidental  contact of dangerous substances with 
the product, taking into account its engi neering design, materials and working 
environment;        the elimination or minimisation of  risk of contagion of patients, users and 
other individuals.  26.  Devices, intended for the application of medicines, shal l be developed and 
produced considering the compatibility with  such medicines and in accordance with 
established requirements for the applicati on of such devices and under the condition 
of preserving their properties according to intended use.  27.  If the device contains, as an integrated  part, a substance that can be considered 
a medicine when used on its own, and that is intended to cause an effect on the human 
body that is complementary to the effect of th e device, it shall be necessary to check, 
following the established order, the safety, quality and efficiency of this substance, taking into account the in tended use of the device. 
 28.  Animal tissues that are employed in  medical products following the intended 
use shall be taken from animals that have  passed the State di sease and sanitation 
inspection.        State bodies of veterinary medicine shall keep data on the territorial origin of 
such animals.        Processing, storage, testing and tr eatment of animal tissues, cells and other 
substances shall be carried out under maxi mum protection. In pa rticular, protection 
against viruses and other diseases shall be  performed by the application of approved 
methods of their destruction or viral inactivation during the production process. 
 29.  Medical products that are supplied sterile shall be designed, produced, sterilised according to approved methods  in proper conditions and wrapped into 
disposable packaging and/or  following corresponding proce dures that ensure their 
sterility, if placed on the market. They shall also be transported and stored in proper 
conditions before the protective packaging is damaged or opened. 
 30.  Packaging systems for non-sterile medi cal products shall ensure their proper 
purity degree, minimise the risk  of bacterial infec tion, if products are supposed to be 
sterilised before use, adequacy for a pplication with taki ng into account their 
sterilisation method, speci fied by the manufacturer. 
   9
31.  The packaging and/or labelling shall en able individuals to distinguish identical 
or similar medical products that are s upplied both as sterile and non-sterile. 
 
Engineering and ecological properties of medical products 
 
32.  If medical products are intended for use together with other products or 
equipment, such combination, including an interface system, shall be safe and shall 
not deteriorate parameters of products. Any restrictions concerning the application of 
such products shall be identified on the label or in the user manual. 
 33.  Medical products shall be  designed and manufactured so as to minimise risks 
as follows:        causing injury, related to physical ch aracteristics, in particular - to volume/ 
pressure ratio, dimensions and ergonomic parameters;        related to followi ng reasonably expected external conditions – magnetic fields, 
electric interactions, electrostatic discharge,  pressure, temperature, pressure gradient 
and acceleration;        interaction with ot her products that are used for investigations and treatments; 
       related to inability to service or to calibrate (as in the case of imp lantation) due 
to the ageing of materials used or fall in  accuracy of any measuring or monitoring 
instrument;  
34.  Medical products shall be  developed and produced so as to minimise the risk 
of items catching fire or explosion under nor mal conditions of use and in the event of 
accidental failure.        Special attention s hould be paid to de vices on application of which action of 
inflammable substances or substances that  could cause an ign ition is expected upon 
them.  
Medical products with measuring function 
 
35.  Medical products with measuring f unction shall be desi gned and produced in 
the way to ensure appropriate accuracy a nd stability in proper limits, taking into 
account their intended use.        A display board for measured values, controls and indicators shall be 
developed in compliance with ergonomic prin ciples and with account of intended use 
of the product.        Measurements taken with the aid of medical products  with a measuring 
function shall be presented in units SI.  
Medical radiation products 
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36.  Medical radiation product s shall be designed and produ ced so as to ensure the 
prevention of:        the irradiation of patients, users a nd other individuals with out the restriction of 
levels that are necessary to achieve therapeutic or diagnostics objectives; 
       harmful irradiation of pa tients, users and other individuals. 
       If medical products are intended to radiate on a dangerous level that is 
necessary for special medical objectives, wh en the advantages are considered to 
outweigh the risk of irradiati on, the user shal l be capable of contro lling such radiation. 
Such products shall be developed and produced  so as to ensure reproducibility and not 
exceeding tolerances of preset parameters.        If medical products are intended to  create potentially dang erous visible and/or 
invisible radiation, they sha ll be equipped with systems of visual and audible warning 
of such radiation.       The user manuals for medical ra diation products shall contain detailed 
information about types of radiation, met hod of protection for patients, users and 
other individuals and ways to prevent misuse.  37.  Medical ionising radiation products shall be designed and produced according 
to the intended use thereof and so as to  ensure the regula tion and control of 
quantitative and qualitative parameters of radiation. 
 
38.  Medical ionising radiation products in tended for X-ray diagnostics shall be 
developed and produced so as to ensure the required level of image quality and/or 
initial indexes for intended medical objectiv es is attained with minimised risks of 
irradiation of patients, us ers and other individuals. 
 39.  Medical ionising radiation products intended for X-ray treatment shall be developed and produced so as  to ensure  reliable control over and regulation of 
optimal irradiation doze, type of beam, power  and intensity (if needed) of radiation.  
 
Requirements to medical products that are connected to power source or 
equipped with such source 
 
40.  Medical products with electronic software system s shall be designed and 
produced so as to ensure reproducibility, reli ability and effectiveness of these systems 
according to the intended use of the product. It  shall be necessary to take actions to 
eliminate or minimise risks,  arising upon system failure. 
       If, during the appli cation of medical produc ts, the safety of patients relies on 
an internal power source, then the means to determine the condition of this source 
shall be provided.        If, during the appli cation of medical produc ts, the safety of patients relies on 
an external power source, the alarm system  shall be provided to signal power failure. 
  11
      Medical products, inte nded to monitor one or severa l clinical parameters of the 
patient, shall be equipped with a signal system  that warns users about situations that 
may cause death or serious health dete rioration of patients, users and other 
individuals.  41.  Medical products that are connected to  a power source, or equipped with such 
source shall be designed and produced whilst ensuring:        the prevention risk of creating elec tromagnetic fields that may interfere with 
other products and equipment on condition of proper use;        the elimination or minimising ri sk of electrocuting on the condition of their 
proper installation and use, as well as on occasional misuse;        the protection of patients, users and other persons from hazards, related to the strength and durability of the device and moving parts;        minimising hazards originatin g from vibrations created by the product 
including the means to restrict vibration esp ecially at its source, apart from vibration 
that is one of working parameters;        minimising hazards originating from  noise generated by the product, including 
means of restriction noise especially at its source, if noise belongs to working 
parameters.        Lead terminals and other termin als, connecting the medical product to the 
electricity source, gas supply, hydraulic and pneumatic power mains which are 
touched by the user,  shall be  developed and produced so as  to minimise all potential 
risks.  42.  Accessible parts of medical products (e xcept for parts and areas intended for 
the supply of heat or heating up to speci fied temperatures) and areas around them 
shall not gain potentially hazardous temper atures under condition of their proper use. 
 43.  Medical products, intended  for the relay of energy or  substances to patients, 
shall be designed and produced so as to  ensure setting up and maintaining the 
intensity of transmission with high accura cy to keep patients, users and other 
individuals safe.  44.  Medical products shall be  equipped with a means to  prevent and/or to signal 
any non-conformity in intensity of energy transmission that could be hazardous. They shall also comprise (if possible) a suita ble means of preventing accidental and 
dangerous surge of energy and/or excess of substances, with clear and comprehensible 
indication of handling an d signalling functions. 
       If the labelling of the medical produ ct contains instructions or labels that are 
essential for its operation a nd indicate preset and/or re gulated parameters, such 
information shall be clear to the user and the patient.  
Information that shall be provided by the manufacturer  12
 
45.  Every medical product shall be accompan ied with information that is essential 
for its safe use, with accounting for b ackground and qualification of users and 
identifying the manufacturer.        Information shall be provided in  Ukrainian and any other language at the 
manufacturer’s discretion, it shall be placed on the label and in the user manual. 
       Information that is essential for sa fe use of the medical product shall be placed 
directly on the product and/or  on the packaging, or in su itable cases on the transport 
container. If products cannot be packaged in dividually, information shall be placed in 
a booklet that shall be supplied with one or mo re medical products. 
       The user manual shall be included with the packaging of each medical product.  46.  Information concerning the applic ation of the medical product may be 
provided in codes. All codes or iden tification colours shall comply with 
corresponding standards. In cases, when ther e are no established standards, code and 
colour legends shall be indicated in  all paperwork accompanying the product. 
 47.  The label on the medical product sh all contain the following information: 
       1) name and geographical locatio n of the manufacturer . For medical products 
that are imported in order to be placed on the market, the label, external packaging or 
user manual (when there is no manufacturer’s  registered office in Ukraine) shall 
contain the name and location of the aut horised representative or the responsible 
supplier, registered in Ukraine;        2) data, needed for the identification of the medical product and its specification by the user;        3) the word “STERILE”, code of th e batch after the word “BATCH”, or serial 
number, date before which safe use of the product is guaranteed, information that the product is disposable (if applied);        4) the words “custom-made product ” (custom-made medical product) and “for 
clinical studies only” (inte nded for clinical studies); 
       5) any special conditions for the storage of the medical product and/or handling it, special operation instructions and preventive measures and/or warnings; 
       6) year of manufacture – for active medical products;        7) sterilisation met hod – for sterile medical products. 
 48.  If the intended applica tion of the medical product is  not clear to the user, the 
manufacturer shall clearly indicate it on the label and in user manual. 
  13
      Medical products and spare parts sh all be identified by batch numbers to avoid 
any potential risk related to thes e medical products and spare parts. 
 49.  Where appropriate, the user manuals may contain:        1) data from clause 47 (with th e exception of sub-clauses 3 and 4) of this 
Technical Regulation;        2) working properties and any unwanted side effects; 
       3) detailed description of parame ters of these products or equipment that is 
essential  for the corre ct selection and safe joint app lication (if the medical product for 
the purpose of its intended use has to be combined or connected with other medical 
products or equipment);        4) full scope of information that  is necessary for the inspection of proper 
installation of the medical produc t and its safe use together with data on the specifics 
and frequency of technical servicing and calibration to ensure the accurate and safe operation for the entire working lifespan;        5) information that is necessary to prevent risks, associated with the implantation of the medical product;        6) information about the risk  of interference, associated with the 
accommodation of the medical product during special investigations or patient 
treatments; 
 
      7) comprehensive guidance for the occasion of damage of sterile packaging and methods for iterated sterilisation;        8) information about processes for preparation for iterated use, including 
cleaning up, disinfection, pack aging, method of sterilisat ion and any restrictions on 
iterations’ number (provided medical produc ts are intended for repeated use). 
       If medical products require sterilis ation before use, this requirement shall be 
indicated either on the packag ing or on the product itself. In structions on cleaning up 
and sterilisation shall comply with the provisions specified in clauses 19-24 of this Technical Regulation;        9) detailed information on pre-trea tment that should be applied before use of 
the medical product (e.g. sterilisat ion, completion of assembling); 
       10) detailed information on the ch aracter, type, intensity  and transmission of 
the radiation employed (if medical products are intended for radiation for medical 
purposes).        User manuals for medical products shall also contain information that allows 
medical staff to warn a patient about all pos sible contraindications  as well as about: 
       precautionary measures if working parameters of medical products change;  14
 
      precautionary measures from the e ffect of magnetic fiel ds, external electric 
oscillations, electrostatic di scharge, pressure and its fl uctuation, acceleration, sources 
of thermo-induced ignition, etc.;        medicines and treatments that ar e intended for use  together with medical 
products and in particular about any restri ctions on the selecti on of these remedies; 
       precautionary measures against any special and extraordinary hazards, related to the disposal of medical products;        medicines that constitute an integrated part of the medical product; 
       accuracy rate, specified for the medical product with measuring function. 
 50.  If compliance with requirements that  are established in this Technical 
Regulation is based on clinical data, such data shall be generated according to DSTU 
4659-1-2:2006 “Clinical investig ations of medical devices for human subjects” (ISO 
14155-1-2; 2003, MOD).  
General requirements  
 
51.  It shall be mandatory for the manufacturer: 
       1) to carry out systematic an alysis of medical pr oducts’ operation and 
corresponding measures to undertake any ne cessary corrective actions taking into 
account the performance levels and/or properties of medical  product and related risks; 
       2) to inform the Ministry of Health of Ukraine immediately about: 
       any failures or deterioration of pe rformance levels and/or working standards of 
the medical product as well as any inadequacy  in the label and user manual , that may 
cause death or severe deterioration to the health of patients, users and other individuals;        any technical and medical precautions, concerning the performance levels and/or working standards of the medical pr oduct, that because of reasons, determined 
in sub-clause 1 of this clause, shall result in the withdrawal of medical products of the 
same type by the manufacturer.  
Conformity assessment procedures 
 
52.  The assessment of conformity of medi cal products that are marked with the 
National Mark of Conformity shall be performed with the use of modules of 
conformity assessment procedures or thei r combinations in compliance with the 
Decree of the Cabinet of Ministers of  Ukraine of 07/10/2003 No 1585 (p.1585-2003) 
“On Approval of the Technical Regulati on of Conformity Assessment Modules and 
Requirements Towards Labelling with the National Mark of C onformity, that are 
Used in Technical Regulat ions” (Ofitsijnyj Visnyk Ukrajiny, 2003, No 41, p. 2175;  15
2007, No 1, p.31) taking into account the speci fics of application of medical products 
as follows:        1) for module A (internal production control): 
       the internal production contro l constitutes the procedure of conformity 
assessment, by which the manufacturer or it s authorised representative, who ensures 
fulfilment of requirements of clauses 19-50 of this Technical Regulation, and in the 
case of placing sterile produc ts and products with measur ing function on the market, 
requirements of this clause of the Tec hnical regulation, guarantees and declares 
conformity of medical products with established requirements; 
       the manufacturer or its authoris ed representative sh all label each medical 
product with the National Mark of Conform ity and shall draw up a declaration of 
conformity following the blank form attached;        the technical documentation shall comprise:  
 -  a description of sterilisation methods (if the medical product is placed 
on the market in sterile form);          -    confirmation that the produc t complies with requirement s,  if coupled with 
the product with parameters , specified by the manufacturer  (if the medical product is 
coupled with other medical product(s) to be used as intended); 
  - label and user manual. 
 
      If medical products are placed on th e market in sterile form, or if they are 
products of class I with the function of m easuring, the manufacturer shall additionally 
carry out one of the conformity assessment procedures following modules D, or E, or 
F.        The implementation of the a bovementioned procedures shall cover: 
      for medical products that are placed on the market in sterile form – production 
processes related to providing and maintaining sterility only;        for products with the measuring f unction – production pro cesses related to the 
conformity of products with metrological requirements only. 
       If such module is applied to produc ts of IIa class, together with procedures 
envisaged in modules D, or E, or F the manufacturer shall draw up a single 
declaration only, in which he shall conf irm and declare the compliance of the 
products’ engineering design w ith requirements of this Technical Regulation, that 
cover the module;        2) for module B (verificati on of type) – technical documentation shall 
comprise:   16
      the results of engineering desi gn calculations, risk assessments, studies 
performed and technical trials;        a statement, declaring whethe r the product contains a substance as an 
integrated part in accordance with clause 4 of this Technical  Regulation and trial 
results;        draft of the label and, if required, of the user manual.        If medical products contain, as an integrated part, a subs tance in accordance 
with clause 4 of this Te chnical Regulation, the designa ted body, following provisions 
of this clause, shall receive consultations or  explanations from th e Ministry of Health, 
concerning application of this subs tance prior to taking a decision; 
       3) for module D (ensuring production quality):        system of quality management of  medical products shall be deemed adequate 
to these requirements, if it is introduced into the enterprise in accordance with the 
provisions of DSTU ISO 13485:2005 “Medi cal products. System of quality 
management. Regulation requirements. (IS O 13485:2003, IDT)”, with the exception 
of clause 7.3;        to assess the system of quality management of medical products, the manufacturer shall submit a request to the designated body (at its own discretion) that 
comprises:  
      -  the name and location of the manufacturer; 
       -  information about the medical product, that is produced in accordance with 
the quality management system;        -  written confirmation, that similar request shall not be submitted to 
alternative designated body;        -  paperwork, concerning the quality management system;        -  if required, the technical documentation on the verified type and copy of the certificate concerning type verification; 
       -  information on the systematic analysis of operation of medical products and 
the undertaking of appropriate actions.        If this module is applied to produc ts of class IIa, the manufacturer shall draw 
up the conformity declaration, in which he guarantees and declar es conformity of 
such products to technical documentation, th at is composed according to module A, 
and ensures compliance with the requirements  of this Technical Regulation that cover 
them;        4) for module E (products quality  assurance) – for medical products, that are 
placed on the market in sterile form, in order to ensure and to maintain it the  17
manufacturer shall apply provisions, dete rmined for systems of quality management 
and supervision by the designated body, according to module D.        The designated body un dertakes assessment of the quality management system 
to determine its compliance with re quirements of DSTU ISO 13485:2005 “2005 “ 
Medical products. System of quality management. Regulation requirements. (ISO 13485:2003, IDT)”.        If this module is applied to cl ass IIa products, the manuf acturer shall draw up 
a conformity declaration, in which he guarant ees and declares the conformity of such 
products to technical documentation, that is composed, according to module A, and 
ensures compliance with the requirements of this Technical Regulation;        5) for module F (product insp ection) prior to the production of medical 
products the manufacturer shall document the operation of the production process, 
including sterilisation, taking into account the moments th at guarantee uniformity of 
production and its adequacy to the choice of type, specified in the certificate of the 
type verification, as well as  to the requirements of this Technical Regulation that 
cover it.        Additionally for medical products th at are being placed on the market in sterile 
form, in order to ensure and to maintain it, the manufacturer shall apply provisions determined for systems of quality management and supervision by the designated body, according to module D.             If this module is applied to  products of class IIa, th e manufacturer shall draw 
up the conformity declaration, in which he guarantees and declares  the conformity of 
such products to technical documentation that is composed according to module A 
and ensures compliance with the requirements  of this Technical Regulation that cover 
them;        6) for module H (comprehensive quality assurance) the designated body shall 
carry out the assessment of the quality management system at the company to 
determine its compliance with requ irements of DSTU ISO 13485:2005 “2005 “ 
Medical products. System of quality management. Regulation requirements. (ISO 13485:2003, IDT)”.        This module may be applied to prod ucts of IIa – IIb classes without provisions 
concerning the investigation of engineering composition. 
 
Conformity assessment of different classes of medical products 
 
53.  Medical products, assigned to class III, that are not custom-made or intended 
for clinical investigations, shall undergo at  the manufacturer’s di scretion a conformity 
assessment according to module H or module B in conjunction with module D or module F.        Medical products, assigned to cl ass IIa, that are not custom-made or intended 
for clinical investigations, shall undergo at  the manufacturer’s di scretion a conformity  18
assessment, according to module H without the investigation of engineering 
composition or module A in conjunction with modules D, or F, or E.  
      Medical products, assigned to class II b, that are not custom-made or intended 
for clinical investigations, shall undergo at  the manufacturer’s di scretion a conformity 
assessment, according to module H without investigation of engineering composition, 
or module B in conjunction with modules D, or F, or E.        Medical products, as signed to class I, that are not custom-made or intended for 
clinical investigations, shall undergo a conformity assessment, according to module A.  
Placing on the market and commissioning custom-made medical products 
 
54.  In order to place on the market or  commission any custom-made medical 
products, the manufacturer or its author ised representative shall draw up a 
notification, designating:        data necessary for the id entification of the corresponding product; 
       a statement that this product is “intended for use by” specified by the surname 
of the patient only;        surname of a doctor or other author ised person who issued the prescription and 
the name of the clinic;  
      particular parameters of the pr oduct according to the medical prescription; 
       conformity of the medical product w ith safety requirements, specified in this 
Technical Regulation, and appropriate motivat ion if requirements of this Technical 
Regulation are not fully observed.        Custom-made medical products shall not be marked with the National Mark of 
Conformity.        In addition, the manufacturer sha ll draw up and preserve paperwork for five 
years that shall enable to  understand the engineering design of the product, its 
working parameters, including the ones expected and to assess conformity to requirements of this Technical Regulation.        The manufacturer shall take actions  to ensure the conformity of the production 
process to the drawn up paperwork.        The manufacturer of custom-mad e medical products sha ll submit their list to 
the Ministry of Health.        During the procedure of conform ity assessment of the medical product, the 
manufacturer and/or designated body shall take into account results of corresponding 
assessments and inspections that have been undertaken, in accordance with this Technical Regulation, on the in termediate production stage.  19
 
      The manufacturer shall be entitled to instruct its authorised representative about the application of confirmation procedures of compliance assessment according 
to approved modules and taking into account  the peculiarities of the application 
thereof, depending on potential risk of  the operation of the medical product. 
       As an exception, the Ministry of H ealth can satisfy the request to allow certain 
medical products that have  not undergone the abovementi oned procedures but the use 
of which is essential for public health to be placed on the market and commissioned.  
Specifics when placing on the market and commissioning systems 
and treatment complexes 
 
55. An authorised representativ e of the manufacturer that awards medical products 
that are marked with the National Mark of Conformity in limits of intended use and in application domain specified by the manufacturer with the aim of their supply for the 
market as a system or a treatment comple x, shall draw up the declaration confirming 
that they:        inspected the compatibility of products and performed operations observing the manufacturer’s instructions;        packaged the system or the tr eatment complex and provided it with user 
information and manufact urer’s instructions; 
        observed the methods of  internal control and inspection. 
 
      If the aforementioned conditions are not adhered to, or if the system or the treatment complex comprise medical produc ts without marking with the National 
Mark of Conformity, or when combination of products is inappropriate from the point 
of view of their intended use,  such system or treatment complex shall be considered 
as an individual medical pr oduct, that shall undergo th e procedure of conformity 
assessment in compliance with clause  53 of this Technical Regulation. 
       If any authorised manufacturer’s re presentative has perfor med sterilisation of 
the system, or of the treatment complex, or of the other medical product, marked with 
the National Mark of Confor mity, that is stipulated by the manufacturer before 
application, they shall undert ake one of the procedures from module F, module D or 
module E at its discretion.        Medical products, specified in cl auses 54-56 of this Technical Regulation, 
shall not be additionally la belled with the National Mark of Conformity. Such 
products shall be accompanied with the information corres ponding to clauses 45-50 of 
this Technical Regulation.        Declarations, related to the above mentioned products, shall be stored for at 
least five years.  
Specifics when placing on the market  and commissioning medical products 
intended for clinical investigations  20
 
      In order to place on the market and commission medical products intended for 
clinical investigations, the ma nufacturer or its authorised re presentative shall draw up 
a notification comprising:        data necessary for the identificati on of the product; 
       the investigation programme, specify ing the objectives, me dical and scientific 
reasons for the implementation thereof, the scope of the work planned and quantity of medical products to be studied;        conclusion of the ethics co mmittee and results of similar studies; 
       surname of the doctor or another representative, who is authorised to conduct 
clinical investigations in addition to the name of the institution that is authorised to carry out studies;        location and time parameters of investigations.        The manufacturer shall draw up and store the paperwork for at least 5 years as 
follows:        general description of the product;        technical design drawings, pr oduction technology, including sterilisation 
methods, layout of parts and blocks; 
 
      descriptions and comments, esse ntial for understanding sa id drawings, layout 
and the product operation principles;        results of the risk analysis of  the medical product taking into account the 
application in full or in part the national st andards, as well as summaries of decisions 
taken in order to implement requirements of this Technical Regulation, if standards are partially applied;        results of design calculations, completed metrological inspections and technical trials.        The manufacturer shall take the necessary action to en sure the production of 
medical products in accordance with the abovementioned documentation.        The manufacturer shall issue a permit to inspect the assessment of these 
actions.        Medical products, intended for clin ical studies shall not be labelled with the 
National Mark of Conformity.        The manufacturer shall inform the Ministry of Health a bout the realisation of 
clinical investigations of  medical products in accorda nce with DSTU 4659-1-2:2006 
“Clinical investigation of medical  devices for human subjects”.  21
 
      Clinical investigations that are carried out with the use of medical products that are labelled according to this Techni cal Regulation with th e National Mark of 
Conformity  under the condition that those pr oducts are not used for purposes that do 
not fit those specified in the conformity a ssessment procedure, shall not be covered 
with provisions of this clause. Such clini cal investigations shall be carried out in 
accordance with DSTU 4659-1-2: 2006 “Clinical investigatio n of medical devices for 
human beings”.  
                                                                     Appendix to the Technical Regulation 
 
DECLARATION 
of conformity 
__________________________________________________________________ 
(full name of the manufacturer, or  
________________________________________________________________________________ 
its authorised representative, or supplier, their 
locations and codes according to EDPNOU (if registered)) 
represented by  _________________________________________________________ 
(position, surname, first name, patronymic of the manufacturer, 
________________________________________________________________________________ 
authorised representative, or supplier) 
 
confirms that the medical product ____________________________________________ 
    (full name of the medical product, type, brand, model) that is being produced following
_____________________________________________ 
    (name and code of the technical documentation)  
complies with the Technical Regulatio n for medical products according to __________________ 
____________________________________________________________________ 
(titles of normative documents (if present)) 
 
Technical documentation on the medical product is drawn out. 
 
Certificate of the type inspection (if present)    _____________________________________ 
____________________________________________________________________ 
(number of the certificate of the type of inspection, its registration date,  
valid until, name and location of the designated  
body) 
   The log sheet of trials of the medical product, carried out by the designated body, or under its 
supervision (if required)__________________________________________ 
    ( n u m b e r  o f  t h e  l o g  s h e e t ,   
________________________________________________________________________________ 
date of completion, name and location 
of the designated body) 
 
The Declaration is drawn up under full responsibility of the manufacturer/authorised 
representative/supplier. 
______________                _________________                _______________ 
(position)                              (signature)                                 (printed name) 
 
SEAL 
_______ Date 
 
Publications to follow with the document:   22
- Ofitsijnyj Visnyk Ukrajiny of 23/06 /2008-2008,N 43, p.101, Article 1415, code 
43331/2008 -  Urjadovyj Kurjer of 25/06/2008 – N 115