1
 
  
 
 
CABINET OF MINISTERS OF UKRAINE  
 
DECREE 
of 16/07/2008  No 641 
Kyiv 
 
On approval of the Technical Regulation  
concerning medical products for laboratory diagnostics in vitro 
  
     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. Approval of the following Technical Regulation concerning medical products 
for laboratory diagnostics in vitro  (hereinafter – the Technical Regulation). 
      2. Designation of the Ministry of H ealth as a responsible body for the introduction 
and application of the Techni cal Regulation as well as supervision of compliance with 
the requirements thereof.       3. The Ministry of Health, togeth er with the State Committee for Technical 
Regulation and Consumer Policy, shall develop and approve within one month the road map for the introduction of the Technical Regulation. 
 Prime-Minister of Ukraine                                                                Ju. Tymoshenko                                                                                 APPROVED                                                by the Decree of the Cabinet of Ministers of Ukraine                                                                              of 16/07/08 No 641  
TECHNICAL REGULATION 
concerning medical products for laboratory diagnostics in vitro  
      2
General provisions 
 
     1. This Technical Regulation determ ines the general requirements for medical 
products for laboratory diagnostics in vitro , and the safety and pr ocedures required in 
order to confirm the compliance ther eof with the said requirements. 
      2. This Technical Regulation has b een drafted in accordance with Directive 
98/79/EC of the European Parliament a nd of the Council of 27/10/1998 concerning 
medical products for laboratory diagnostics in vitro.  
      3. For the purposes of this Technical  Regulation, terms shall have the following 
meanings:        putting into service – readiness of  a medical product for laboratory diagnostics in 
vitro  for first use and for an intended purpose; 
       placing on the market – first a ppearance of a medical product for laboratory 
diagnostics in vitro , with the exception of products in tended for clinical trials, for 
distribution and/or for use for an intended purpose on the Ukrainian market irrespective of whether the produc t is brand new or modified; 
       medical product for laboratory diagnostics in vitro – any medical product which is 
a reagent, reagent’s reaction product, calib rator, control material, set of tools, 
individual tool, instrument, equipment, or system whether used alone or in 
combination with other medical products, in tended by the manufacturer to be used in 
vitro  for specimen examination, including bl ood and tissue donati ons, derived from 
the human body, solely or principally for the purpose of providing information for 
determination of:       -  physiological and pathologi cal state; 
      -  problems with intraute rine development of the foetus; 
      -  safety and compatib ility with potential recipients; 
      -  therapeutic measures;       receptacles for specimen storage – devices employing a vac uum or of any other 
type that are specifically intended by the manufacturer for the primary containment 
and preservation of specimens de rived from the human body for in vitro diagnostic 
investigation . 
 
     Receptacles for specimen storage belong to medical products for laboratory 
diagnostics in vitro. 
 
    Any equipment or appliance 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 medi cal products for laboratory diagnostics in vitro . 
  3
     Products for general laboratory use are not in vitro laboratory diagnostics medical 
products  unless such products in view of their parameters are specially intended by 
the manufacturer to be used for in vitro  diagnostic investigations; 
         kit – products that alone are no t medical products for laboratory diagnostics in 
vitro , but that are specifi cally intended to be used toge ther with such medical products 
or as a part thereof, in order to achiev e the aim of operation of medical products as 
intended;       medical product fo r laboratory diagnostics in vitro for self-testing – products 
intended by the manufacturer to be used  domiciliary and by the patient itself; 
      medical product fo r laboratory diagnostics in vitro intended for performance 
evaluation –  products that are intended by th e manufacturer to be subject to one or 
more performance evaluation studies in medi cal analytical laboratories or in other 
appropriate environment out side its own premises; 
      calibrators and control materials – substances, materials or  kits intended by the 
manufacturer either for establishing relati onships between measurements or verifying 
the performance characteristic s of the instrument in conj unction with the intended use 
thereof;       accessories – articles that are not medical products for laboratory diagnostics in 
vitro , but which are specifically intended by the manufacturer to be used in 
combination with the medical product to enab le such product to be used correctly.  
 
     For the purpose of this definition, invasive sampling devices  or devices intended 
for obtaining a specimen within the meaning of the Technical Regulation concerning the conformity assessment of the safety of medical products drawn out in accordance 
with European Council Directiv e 93/42/EC shall not be cons idered to be accessories 
to medical products for laboratory diagnostics in vitro . 
      Other terms shall be used in the m eanings thereof as specified in the Laws of 
Ukraine “On Confirmation of Compliance” (2406-14),  “On Standardisation” (2408-
14),  “On Accreditation of Conformity  Assessment Bodies” (2407-14),  “On 
Standards, Technical Regul ations and Conformity A ssessment Procedures” (3164-
15),  “On Medicines” (123/96-VR).       4. The requirements stipulated in th is Technical Regulations are mandatory for: 
           manufacturers of medi cal products for labo ratory diagnostics in vitro 
(hereinafter – manufacturer);        persons – residents of Ukraine,  who are authorised by the manufacturer 
(hereinafter – authorised person);        persons who are responsible fo r placing medical pr oducts for laboratory 
diagnostics in vitro on the market or putting them into service, if the manufacturer or 
its authorised person do not exercise activitie s on the territory of Ukraine (hereinafter  4
– person who placed medical products for laboratory diagnostics in vitro  on the 
market or put them into service);       central executive authorities and their bodies functioning in technical regulation and supervision of the safety of medi cal products for laboratory diagnostics in vitro  
(hereinafter – central executive bodies);        designated bodies for assessing conf ormity of medical pr oducts for laboratory 
diagnostics in vitro  that conform to the requirement s established in Decree of the 
Cabinet of Ministers of Ukraine No 59 of 24/01/2007 (59-2007-p) “On Approval of 
the Order of Implementation of Procedure of Appointment of th e Bodies Assessing 
the Conformity of Products, Processes and Se rvices to the Requirements of Technical 
Regulations” (Ofitsijnyj Visnyk Ukraji ny, 2007, No 6, p. 223) (hereinafter – 
designated bodies).       5. If a substance constitutes an integr al part of the medical product for laboratory 
diagnostics in vitro,  and this substance can  be solely used as a remedy, as determined 
in the Law of Ukraine “On Medicines” ( 123/96-VR), and benef its the human body in 
a way that is complementary to the effect of the medical product for in vitro 
laboratory diagnostics, the safe ty, quality and efficiency of such medicine shall be 
examined taking into account the intended purpose of the product in accordance with the Law of Ukraine “On Medicines” (123/96-VR).       6. Placing medical pr oducts for laboratory diagnostics in vitro – which are covered 
by this Technical Regulation -  on the market and putting them  into service shall be 
permitted if this does not endanger the life and health of patients, users and other 
persons, and on condition that correct inst allation, servicing a nd application are 
provided.  
The customer shall be informed about the decision taken on the basis of this 
Technical Regulation that re stricts the placing of medi cal products for laboratory 
diagnostics in vitro into free circulation on the market, as well as of the relevant 
grounds and reasons thereto. At the same ti me, the customer shall be notified about 
protective measures envisaged by legislati on and the duration of their validity.   
      7. For the purpose of this Technical Regulation and in view of intended use of 
medical products for laboratory diagnostics in vitro, as well as for the conformity 
assessment procedure, said products are included in lists A and B (Appendix 1). 
      8. Compliance of medical pr oducts for laboratory diagnostics in vitro  with the 
requirements of the National Standards confirms the conformity thereof with the provisions of this Technical Regulation.       The list of National Standards shall include monographs of European 
Pharmacopoeia concerning surgical suture s and interaction between medicines and 
materials that are used in medicina l products for laboratory diagnostics in vitro  that 
contain such medicines. Monographs sha ll be submitted by the State Committee for 
Technical Regulation and Consumer Policy.   5
     9. Electromagnetic compatibility of medical products is regulated by DSTU IEC 
60601-1-2-2001 “Medical Electri cal Equipment. General Requirements to Safety. 
Additional Standard. Electromagnetic comp atibility. Requirements and Tests” (IEC 
60601-1-2:1993, IDT).       The Technical Regulation con cerning confirmation of compliance of 
electromagnetic compatibil ity does not cover medical products for laboratory 
diagnostics in vitro . 
      10. Prior to placing on the market or putting into servi ce medical products for 
laboratory diagnostics in vitro , or packaging thereof and/or accompanying documents, 
notifications, or instructions shall be marked with the National Mark of Conformity in 
observance with the Decree of  the Cabinet of Ministers of Ukraine of 29/11/2002 No 
1599 (1599-2001-p, 1599a-2001-p) “On Approval of  the Description and Rules of 
Application of the National Mark of C onformity” (Ofitsijnyj Visnyk Ukrajiny, 2001, 
No 49, p. 2188). This provision does not co ver medical products for laboratory 
diagnostics in vitro that are intended to undergo an a ssessment of performance levels. 
      Use of the National Mark of Conform ity shall be exercised in accordance with the 
requirements set out in Decree of the Cabi net of Ministers of Ukraine of 07/10/2003 
No 1585 (1585-2003-p) “On Approval of the Technical Regulation on Modules of 
Conformity Assessment and Requirements on Marking with the National Mark of 
Conformity that Are Used in Technical Regulations” (Ofitsijnyj Visnyk Ukrajiny, 2003, No 41, p. 2175).       11. If medical products for laboratory diagnostics in vitro are marked with the 
National Mark of Conformity, this means that  the legal or natural person that marked 
the product, or that is  responsible for the ma rk, has inspected and confirms conformity 
of the medical products fo r laboratory diagnostics in vitro with the requirements of 
this Technical Regulation and the passing of  appropriate procedures of conformity 
assessment.       12. If medical products for laboratory diagnostics in vitro fall within the scope of 
any other technical regulations relating to marking with the National Mark of 
Conformity, such medical products shall al so conform to the requirements of those 
technical regulations. Complia nce of medical products with  all technical  regulations 
shall be a condition for being grante d the National Mark of Conformity. 
      If one or several technical regulations  set out the manufactur er’s right to choose 
the way in which compliance is confirmed, the granting of the National Mark of Conformity shall mean compliance with onl y those technical regulations that have 
been used by the manufacturer. In such  a case, documents, notifications and 
instructions that accompany medical  products for laboratory diagnostics in vitro shall 
contain references to the technical regulations used. 
      13. If it is discovered that the Nationa l Mark of Conformity is  used in violation of 
the requirements set out in this Technica l Regulation, then the manufacturer or 
authorised representative, or the person who placed the medical products on the 
market or put them into service, shall take  actions to cease such violation and shall 
ensure that the medical products are brought into conformity with  the requirements of  6
this Technical Regulation, as well as confirming such compliance according to the 
established order.       If the law is violated, central execu tive bodies shall undertake appropriate action to 
restrict or to ban such medical products from being placed on the market, or shall 
withdraw them from the market.       Any decision taken in observance of this Technical Regulation concerning 
restriction or banning from placing on the mark et or putting into service of medical 
products for labora tory diagnostics in vitro,  or the withdrawal thereof from the 
market, shall comprise a clear account of reasons on which the decision is founded. 
The party concerned shall be immediately in formed of this deci sion. In addition, 
information shall be provided in respec t to terms and conditions for undertaking 
action according to legislation in order to eliminate violations in question. 
      14. Central executive bodies shall not cause any obstructions for physicians to get the possibility to use medical prod ucts for laboratory diagnostics in vitro  that are 
intended for use in performance level asse ssments, if those products conform to the 
requirements of Clauses 104-106 of this T echnical Regulation. These products shall 
not be marked with the Na tional Mark of Conformity. 
       15. Exposition of medical products for laboratory diagnostics in vitro  that have 
not passed the procedure of conformity asse ssment according to requirements of this 
Technical Regulation on trade fairs, exhibitions, demonstr ations of medical products 
shall be permitted on condition that the manuf acturer clearly labelled the information 
that those products cannot be placed on the market or pu t into servi ce until they 
conform to the requirements of  this Technical Regulation. 
      16. Following the results of the appl ication, the Ministry of Health performs 
constant monitoring and assessment of a ny information about medical products for 
laboratory diagnostics in vitro  that have been placed on the market or put into service, 
and concerning:       failure or deterioration of performan ce levels and/or propert ies of medical products 
for laboratory diagnostics in vitro , any misleading information on the label or in the 
user manual that could result or has already resulted in d eath or serious deterioration 
in the health of patients,  users and other persons; 
      technical or medical reasons for th e alteration of performance levels and/or 
properties of medical products  for laboratory diagnostics in vitro  that have resulted in 
the systematic recall thereof by the manufacturer.       Physicians and public health in stitutions shall submit the abovementioned 
information to the Ministry of Health, manufacturers or their authorised representatives in orde r to keep records and carry out analyses. 
      17. If it is discovered that me dical products for laboratory diagnostics in vitro  that 
are provided with correct installation, servic ing and application continue to be prone 
to endangering the health and safety of patie nts, users and other persons, all possible  7
actions shall be taken to withdraw such produc ts from the market or to ban or restrict 
them from being placed on the market or put into service, in accordance with the law. 
 
Requirements concerning design and manufacture of medical products for 
laboratory diagnostics in vitro 
 
     18. Medical products for laboratory diagnostics in vitro shall be designed and 
manufactured in a manner that ensures th e minimisation of risks to the health and 
safety of patients, users and third parties.  
 
     It is assumed that any potential risks that might be related to a pplication of medical 
products are tolerable when compared with the positive effect for the patient if a good level of life and protecti on of health is provided. 
      19. Technical solutions implemented by the manufacturer in the process of the 
design and production of medical pr oducts for laboratory diagnostics in vitro shall 
correspond to the most current safety requirements.       On taking solutions, the manufacture r shall principally adhere to the following 
guidelines:            elimination or maximal reduction of  potential risks on a pplication of medical 
products for laboratory diagnostics in vitro ; 
       taking appropriate protection measur es including alarm signa ls to avoid potential 
risks that cannot be eliminated on applic ation of medical products for laboratory 
diagnostics in vitro ; 
      informing users about potential ri sks on application of medical products for 
laboratory diagnostics in vitro  that exist because proper protection measures cannot be 
used.       20. Medical products for laboratory diagnostics in vitro shall be designed and 
produced in accordance with the requirements of this Technical Regulation and on 
condition that these products sha ll be used directly as intended. 
      The abovementioned medical products  shall correspond to accredited state-of-the-
art and state-of-the-industry exploitation characteristics. 
Those characteristics shall include:       analytical sensitivity;       diagnostics sensitivity;       analytical selectivity;       diagnostics specificity;       accuracy;   8
     repeatability and reproducibility; 
      relevant interference control;           detection limits specified by the manufacturer;       values, provided with calibrators and/ or control materials shall be reproducible and 
metrologically traceable through reference measurement procedures and standard 
reference materials.       21. The characteristics, propertie s and performance of medical products for 
laboratory diagnostics in vitro shall not be adversely change d to such a degree that the 
health and safety of the patient, user, or other person is co mpromised when the 
product is subjected to the stresses that can  occur during normal conditions of storage 
and operation, and when correct installati on, servicing, use and lifetime limits are 
provided in accordance with the manufacturer’s instructions. 
      22. Medical products for laboratory diagnostics in vitro shall be designed, 
produced and packaged in such a way that the characteristics and performance thereof 
will not be changed under storage and transportation conditions.       23.  Medical products for laboratory diagnostics in vitro shall be designed and 
manufactured according to provisions of this  Technical Regulation in  such a way as to 
maintain appropriate paramete rs and performance levels. Pa rticular attention must be 
paid to the possibility of impairment of  analytical performance as a result of 
incompatibility between the materials used  and the specimens (biological tissues, 
cells, bodily fluids and micro-organisms) intended to be used with the medical 
product for laboratory diagnostics in vitro, taking into accoun t its intended use. 
      24. Medical products for laboratory diagnostics in vitro shall be designed, 
manufactured and packaged in such a way as to minimise risks of contamination thereof during transportation, stor age and application as intended. 
      25. Medical products for laboratory diagnostics in vitro shall be designed in such a 
way as to eliminate or to minimise risk  of infection to users or other persons. 
Engineering design must allow easy handli ng and, where necessary, reduce as far as 
possible the risk of leakage contaminati on during the operation of medical products 
for laboratory diagnostics in vitro. 
 
     26. Where a medical product fo r laboratory diagnostics in vitro incorporates 
biological substances, the risk  of infection must be reduced as far as possible by 
selecting appropriate validate d inactivation, conservation, te st and control procedures. 
      27.  Medical products for laboratory diagnostics in vitro  labelled either as 
“STERILE” or specifically intended for mi crobiological investig ations, shall be 
designed, produced and packaged in such a wa y as to ensure the preservation of the 
microbiological state indicated on the labe l, when placed on the market, under the 
storage and transportation conditions sp ecified by the manufacturer until the 
protective packaging is damaged or opene d. Such medical products shall undergo 
treatment (sterilisation) according to established requirements.  9
 
     28. Packaging systems for medi cal products for laboratory diagnostics in vitro 
other than those referred to in the requi rements of Clause 27 of this Technical 
Regulation shall ensure the storage of pr oducts without deterior ation of the purity 
grade indicated by the ma nufacturer and, if medical products for laboratory 
diagnostics in vitro are to be sterilised before us e, reduce the risk of microbial 
contamination.       Action shall be also taken to reduce microbial contamination during the selection and handling of raw materials, producti on, storage and distribution of medical 
products for laboratory diagnostics in vitro.  
      29. Medical products for laboratory diagnostics in vitro  that require sterilisation 
shall be manufactured in appropriately controlled conditions (e.g. environmental 
parameters).       30. If medical products for laboratory diagnostics in vitro  are intended for use in 
combination with other devices or me dical products, the whole combination, 
including the connection terminals, must be  safe and must not impair the specified 
performance levels of medical products for laboratory diagnostics in vitro.  Any 
restrictions in use must be indicated on the label or highlighted I the user manual. 
      31. Medical products for laboratory diagnostics in vitro  shall be designed and 
produced in such a way as to:       eliminate or reduce risks: 
 
     -  linked to their use in conjuncti on with materials, subs tances and gases with 
which they may come into contac t under normal conditions of use; 
      -  of injury related to deteriorati on of their physical parame ters, in particular – 
volume and pressure, dimensions , ergonomic parameters, etc.; 
      -  linked to reasonably expected ex ternal influences such as magnetic fields, 
external electrical effects,  electrostatic discharges, pressure, humidity, temperature, 
variations in pressure or acceleration, or accidental pene tration of substances into 
medical products for laboratory diagnostics in vitro; 
 
     -  of catching fire or explosion under normal conditions of use. Special attention 
shall be paid to equipment which, when used as intended, allows application of 
flammable substances or substances that may ignite;       ensure adequate level of intrin sic irresponsiveness towards electromagnetic 
oscillations;       make waste disposal easy and safe.       32. The measuring, control and display scale (including colour changes and other 
visual indicators) shall be designed and manufactured in line with ergonomic  10
principles, taking into account the intende d purpose for use of the medical products 
for laboratory diagnostics in vitro. 
 
     33. Medical products for laboratory diagnostics in vitro  that are instruments or 
apparatus having a primary analytical m easuring function shal l be designed and 
produced in such a way as to provide adequate stability and accuracy of measurements within appropriate accuracy  limits, taking into account the intended 
purpose of the medical product for laboratory diagnostics in vitro  and of available 
reference measurements procedures and ma terials. The accuracy limits must be 
specified by the manufacturer.       34. When the values of measur ements by medical products for laboratory 
diagnostics in vitro  are expressed numerically, th ey shall be given in units 
acknowledged in Ukraine.       Medical products for laboratory diagnostics in vitro  shall be designed, 
manufactured and packaged in such a way th at exposure of users and other persons to 
the emitted radiation is minimised.       When medical produc ts for laboratory diagnostics in vitro  are intended to emit 
potentially hazardous radiation, they  shall as far as possible be: 
      designed and manufactured in such a way as to make characteristics and quantity 
of radiation emitted contro llable and adjustable; 
      fitted with visual or audible al arm signals to warn of such emissions. 
 
     35. The operating instructions for medical products for la boratory diagnostics in 
vitro that emit radiation shall provide detailed information as to the nature of the 
emitted radiation, means of protecting the user s, and ways to avoid misuse of medical 
products for laboratory diagnostics in vitro  and eliminating risks on installation. 
      36. Medical products for laboratory diagnostics in vitro  incorporating electronic 
programmable systems, including software, sh all be designed so as to ensure the 
repeatability, reliability a nd performance levels of these systems according to the 
intended use of the system.       37. Medical products for laboratory diagnostics in vitro  shall be designed and 
manufactured in such a way as to:       minimise the danger of:       -  electromagnetic fields that c ould impair the operation of other systems and 
medical products in the vicinity;       -  accidental electric shock during normal use and single fault condition, provided 
that the medical products for laboratory diagnostics in vitro  have been installed and 
used correctly;   11
     ensure protection against mechanic al risks. Medical products for laboratory 
diagnostics in vitro shall be sufficiently stable under the expected operating 
conditions. They shall be suitable to withsta nd stresses that could be expected in the 
working environment, and to retain this resistance during the expected lifespan of 
medical products for laboratory diagnostics in vitro , as well as accessibility to any 
inspection, as specified by the manufacturer.       When there are risks related to m oving parts, risks arising from break-up or 
detachment, or leakage of substances, th e appropriate protecti on actions shall be 
taken.       Any precaution means included with medical products for laboratory diagnostics 
in vitro to provide safety, in partic ular in respect to moving pa rts, shall be secure and 
shall not interfere with access for the norma l operation of the medical products for 
laboratory diagnostics in vitro or restrict the maintenance of products as indicated by 
the manufacturer;       reduce to the lowest possible level a ny risk arising from vi brations generated by 
products, taking account of technical progress and the means suitable for limiting vibrations, particularly at the source, unless the vibrati ons are part of the product’s 
working cycle;       reduce risks arising from the nois e emitted during the operation of the product, 
taking account of technical progress and the means suitable to reduce noise directly at 
the source, unless the noise is part  of the product’s working cycle. 
 
     38. Terminals and connections to elec tricity, gas or hydraulic and pneumatic power 
supplies which the user must  handle shall be designed and manufactured in such a 
way as to minimise all possible risks.       39. Accessible parts of medical  products for laboratory diagnostics in vitro  
(excluding the parts of areas intended to suppl y heat or reach preset temperatures) and 
their surroundings shall not attain potenti ally dangerous temperatures under normal 
use.       40. Medical products for laboratory diagnostics in vitro  intended for self-testing 
shall be designed and produced in such a way that they perform appropriately for their 
intended purpose taking into account the skil ls of users and the influences expected 
from variation of application technique  and environment. The information and 
instructions provided by the ma nufacturer shall be easily comprehensible for the user. 
      41.  Medical products for laboratory diagnostics in vitro  intended for self-testing 
shall be designed and produced in such a way as to:       be easy to use by the potential user at all stages of the procedure; 
      reduce as far as possible the risk of  user error in the handling of such medical 
devices and in the interp retation of the results. 
  12
     42. Medical products for laboratory diagnostics in vitro  intended for self-testing 
shall include control procedure, i.e. a pro cedure by which the user can verify that, at 
the time of use, performance leve ls of the product did not change. 
      43. Each product shall be accompanied by  the information required to use it safely 
and correctly, taking into account the traini ng and knowledge levels of the potential 
users.       This information comprises data on the label and in the user manuals.       The information required to use medical products for laboratory diagnostics in 
vitro  safely and correctly shall be set out on the product itself  and its packaging. If the 
packaging of each unit of medical products for laboratory diagnostics in vitro is not 
practicable, the information shall be set out in the user manual or the label supplied with one or more units of medical  products for laboratory diagnostics in vitro. 
 
     The user manuals shall be contained in the packaging of every type of medical 
product for laboratory diagnostics in vitro. 
 
     44. In some cases, the information for the user should be provided in the form of 
symbols.  Any symbol or identification co lour used shall conform to the harmonised 
national standards. If no st andards exist, the symbol and colour used shall be 
described in the documentation supplied with medical products for laboratory 
diagnostics in vitro. 
  
      45. For medical products for laboratory diagnostics in vitro containing a 
preparation that is considered as potentia lly dangerous, in view of the nature and 
quantities of its components and the form in which they are present, relevant 
requirements for danger symbols and other ma rkings shall be observed. Where there 
is insufficient space to put all the information on the medical product for laboratory diagnostics in vitro  itself or on its label, relevant  danger symbols shall be put on the 
label and the other information shal l be provided in the user manual. 
      46. The label shall contain:       the name or trade name of the ma nufacturer. For medical products for laboratory 
diagnostics in vitro , which are imported/exported, the la bel, external packaging or the 
user manual must contain the name and locat ion of the authorised person in Ukraine; 
      the details necessary for the user to identify the medical product for laboratory 
diagnostics in vitro  and the contents of the packaging; 
      the word “STERILE” and steril isation method (if the medical product for 
laboratory diagnostics in vitro  is sterile); 
 
     the batch code, preceded by the word “BATCH”, or the serial number; 
      the date (month and y ear), by which safe use of the medical product for laboratory 
diagnostics in vitro shall be allowed; 
  13
     words “for performance evaluati on only” (if medical pr oducts for laboratory 
diagnostics in vitro  are intended for performance evaluation); 
      a statement indicating the in vitro  use of the medical products for laboratory 
diagnostics in vitro  (where appropriate); 
      any particular storage and/or handling conditions for medical products for in vitro  
diagnostics (where appropriate);       any particular operation instructions (where applicable); 
      if the medical products for laboratory diagnostics in vitro  are intended for self-
testing, this shall be clearly indicated.       47. If the intended purpose of the medical product for laboratory diagnostics in 
vitro  is not obvious to the user , the manufacturer shall st ate the intended purpose in 
the user manual and, where appropriate, on the label.       48. Wherever reasonable, medical  products for laboratory diagnostics in vitro  and 
their separate components shall be identifie d so as to allow appropriate actions to 
detect any potential risk that may be  posed by the product or its components. 
 
 
     49. The instructions for use shall contain the following particulars: 
      the name and location of the manuf acturer. For medical pr oducts for laboratory 
diagnostics in vitro  that are imported or exported, the label, or the external packaging, 
or the user instructions must  contain the name and location of the authorised person in 
Ukraine;  
      the details necessary for the user to id entify the medical product for laboratory 
diagnostics in vitro  and the contents of the packaging; 
     the word “STERILE” and sterilis ation method (if the medical product for 
laboratory diagnostics in vitro  is sterile); 
 
     words “for performance evaluation only”  (if medical products for laboratory 
diagnostics in vitro  are intended for performance evaluation); 
 
     a statement indicating the in vitro  use of the medical products for laboratory 
diagnostics in vitro  (where appropriate); 
 
     any particular storage and/or handling conditions for medical products for in vitro  
diagnostics (where appropriate);  
     any particular operating instructions (where applicable); 
      if the medical products for laboratory diagnostics in vitro  are intended for self-
testing, that shall be  clearly indicated; 
 
  14
      composition of the reagent by nature and amount or concentration of the active 
ingredient(s) of the reagent(s) or kit as well as a statement, where appropriate, that  the medical products for laboratory diagnostics in vitro contain other ingredients that 
might influence the measurement;       the storage conditions and shelf lif e following the first ope ning of the primary 
container, together with the storage conditi ons and stability of the working reagents; 
          indications on any special medi cal products for laboratory diagnostics in vitro  
required including information necessary fo r the identification of special medical 
products for laboratory diagnostics in vitro for proper use; 
      the type of specimen to be used, a ny special conditions of collection, pre-treatment 
and, if necessary, storage conditions and instru ctions for the preparation of the patient; 
      a detailed description of the procedures to be used  following the application of 
medical products for laboratory diagnostics in vitro; 
 
     the measurement procedure with the medi cal products for labor atory diagnostics in 
vitro; 
 
     the principle of the method; 
      the specific analytical paramete rs (e.g. sensitivity, specificity, accuracy, 
reproducibility, limits of detection and m easurement range, including information 
required for the control of known relevant interferences), limitations of the method 
and information about the use of availabl e reference measurement procedures and 
reference materials;       any procedures required before th e medical products for laboratory diagnostics in 
vitro can be used (for example, dissolution,  incubation, dilution, instrument checks, 
etc.);       the mathematical approach used for calculation of the analyses’ results; 
      measures to be take n in the event of changes to the analytical performance of 
medical products for laboratory diagnostics in vitro; 
 
     information necessary for users on internal quality control including specific 
validation procedures, and on the traceabilit y of the calibration of medical products 
for laboratory diagnostics in vitro ; 
      the reference intervals for the quanti ties being determined, in cluding a description 
of the appropriate reference population;       if medical products for laboratory diagnostics in vitro  must be used in combination 
with other medical products or installed with or connected to other devices in order to 
operate as required for its intended purpose, sufficient details of its characteristics to 
select correctly the type of aforementioned pr oducts or devices to ensure the safe and 
correct functioning of the combination of products;  15
 
     all the information required to veri fy whether the medical product for laboratory 
diagnostics in vitro  is correctly installed and can operate correctly and safely, as well 
as conditions of maintenance and calibrati on required to be sure that the medical 
products for laboratory diagnostics in vitro  operates correctly and safely; 
      information about safe waste disposal;       details of any treatment needed be fore medical products for laboratory diagnostics 
in vitro  can be used ( for example, ster ilisation, final assembly, etc.); 
      the necessary instructions in the ev ent of damage to the protective packaging and 
details of appropriate methods of re -sterilisation and decontamination; 
      if medical products  for laboratory diagnostics in vitro  are reusable, information on 
the appropriate processes to allow reuse, including cleaning, di sinfection, packaging 
and re-sterilisation or decontamination, and any restriction on iterative use; 
      any precautionary measures to be ta ken as regards exposure to magnetic fields, 
external electric fields, electrostatic discha rges, pressure or variations in pressure, 
acceleration, thermal ignition sources, etc.;       any precautionary measures to be take n against any special, unusual risk related to 
the use and disposal  of medical products for labo ratory diagnostics in vitro , including 
special protective measures;  
     where medical products for laboratory diagnostics in vitro  include substances of 
human or animal origin, attention must be drawn to their potential infectious nature; 
      date of issue and last re vision of the operation instruction; 
            specific requirements in respect to operating instructions fo r products for self-
testing:       the results must be expressed and pr esented in a way that is readily understood by 
the user;       information must be provided with advi ce to the user on action to be taken (in case 
of positive, negative or intermediate results) and on the possibility of receiving false positive or false negative results;       specific particulars may be omitte d on the condition that any other information 
supplied by the manufacturer is sufficient to enable the user to use products and to understand the results produced;       the information provided must include a statement clearly indicating that the user 
should not take any decision of a medical nature without first consulting a medical 
practitioner;   16
     the information must also specify th at when a product for se lf-testing is used for 
monitoring an existing diseas e, the user should continue  to apply the prescribed 
treatment, if they received the appropriate training.    
Conformity assessment procedures 
 
     50. Assessment of conformity of medical products for laboratory diagnostics in 
vitro  with the provisions of the Technical Re gulation shall be perf ormed with the use 
of modules of conformity assessment pr ocedures or combinations thereof in 
accordance with Decree of the Cabinet of  Ministers of Ukraine of 07/10/2003 No 
1585 (1585-2003-p) “On Approval of the T echnical Regulation of Conformity 
Assessment Modules And Requirements Toward s Marking with the National Mark of 
Conformity that Are Used in Technical Regulations” (Ofitsijnyj Visnyk Ukrajiny, 2003, No 41, p. 2175; 2007, No 1, p.31) taking into account the specifics of the application of medical products.       51. Internal production control constitu tes the procedure of conformity assessment, 
by which the manufacturer th at observes the requirements of Clauses 52-55 of this 
Technical Regulation and, when placing pr oducts intended for self-testing on the 
market, the requirements of Clause 56 of th is Technical Regulation shall also apply, 
guaranteeing and declaring that the speci fied medical products conform to the 
relevant requirements of this Technical Regulation. The manufacturer shall mark each 
product with the National Mark of Conform ity and shall draw up the Declaration of 
conformity (see Annex 2).  
 
     52. The manufacturer shall prepare th e technical documentation in accordance with 
Clause 53 of this Technical Regulation, shall retain it together with  the Declaration of 
conformity for 5 years after production of the last specimen of the product and shall 
submit it on request from the central executive bodies for examination. In addition, the manufacturer shall ensure the conformity of the production process with the principles of quality management stipul ated in Clause 54 of this Technical 
Regulation.       53. The technical documentation shall cover all stages of the design, manufacture 
and application of the products and shall allo w the conformity of the products with the 
provisions of this Technical Regulation to be assessed.       In particular, the techni cal documentation shall comprise: 
      a general description of the product, including any planned variants; 
      the documentation of the quality management system;       design drawings, projected method of manufacture, diagrams of components, 
blocks, circuits, etc.;        the descriptions and explanations  necessary to understand the characteristics, 
drawings and diagrams and operation of the product;  17
 
     in the case of devices that contain human tissues or substances derived from such 
tissues, information on the origin of such material and on the conditions in which it 
was collected;            the results of the risk analysis and a list of the standards from the index of the 
national standards referred to in Clause 8, app lied in full or in part, and descriptions of 
the solutions adopted to meet the essential requirements of this Technical Regulation, 
if the standards have not been applied in full;         in the case of sterile products or pr oducts with a special microbiological state or 
state of purity, a descripti on of the procedures used; 
      the results of the design calculati ons and the inspections carried out, etc.; 
      if the device is to be combined with other device(s) in order to operate as intended, 
proof shall be provided  that it conforms to the essential requirements when combined 
with any such device(s) having the para meters specified by the manufacturer; 
      the test reports;       
 the labels and instruction for use. 
      54. The manufacturer shall take the necessary action to ensure that the quality 
management system of the manuf acturing process is controlled. 
     
     The system shall provide information relating to: 
      the organisational st ructure and responsibilities; 
      the manufacturing processes and systematic quality control of products; 
      the means for monitoring the perfor mance of the quality management system. 
      55.
 The manufacturer or its authorised repr esentative shall establish and keep up to 
date a systematic analysis of experience ga ined from operation of  devices after their 
production and shall implement appropriate means to apply any necessary corrective 
actions, taking account of the nature of  the product and related risks. The 
manufacturer shall notify the Ministry  of Health of the following incidents 
immediately on learning of them:       1) any failure of or deterioration in  the characteristics and/or performance 
parameters of a product, as well as any inadeq uacy in the labelling or instructions for 
use that might lead to, or might have led t o, the death of a patient or user or to a 
serious deterioration in th e state of their health; 
       2) any technical or medical grounds in connection with the characteristics or the 
performance parameters of a product, which for the reasons referred to in sub-clause 
1), lead to systematic recall of product s of the same type by the manufacturer. 
  18
     56. For products intended for self-tes ting, the manufacturer or its authorised 
representative shall be responsible for s ubmitting a request for the examination of the 
design by a designated body.      The request shall make the design of  the product understandabl e and shall make it 
possible to carry out the procedure for asse ssing conformity with  the provisions of 
this Technical Regulation and it shall also include:       test reports that include, where appr opriate, results of studi es carried out with 
patients;       data showing the ease of use of the product, in view of its intended use for self-testing purposes;       the information to be provided with th e product on its labelli ng and its instructions 
for use.       57. The designated body shall be responsible for considering the request for examination of the product's design and, if it conforms to the provisions of this 
Technical Regulation, shall i ssue the applicant with a design-examination certificate. 
The designated body may request additional da ta concerning subsequent trials or 
confirmations to allow assessment of confor mity of design with the requirements of 
this Technical Regulation. The certificate shall contain the conclusions of the 
examination, the data needed for identific ation of the examined design and, where 
appropriate, a description of the intended purpose of the product. 
 
     58. The manufacturer or its authoris ed representative shall inform the designated 
body that issued the design-examination cer tificate of any significant design changes 
made to the examined product, which shall make further examination necessary if they might affect the conformity of th e product with the re quirements of this 
Technical Regulation or with the specifi ed conditions of us e of the product. 
Information concerning additional examina tion shall be appended to the original 
design-examination certificate.       59. Module B contains a description of  the conformity assessment procedures by 
means of which the designated body gains assurance and confirmation that the 
representative sample of a specified medical product conforms to the relevant 
requirements of this Technical Regulation.       60. The manufacturer shall submit a re quest for examination of a sample to the 
designated body selected  by it, including: 
      the name and location of the manuf acturer. If the request is submitted by an 
authorised representative, the latter's name  and location, as well as the aut horisation 
documents;       written confirmation that no similar request has been submitted to any other designated body;       technical documentation in line with Clause 61 of this Technical Regulation;  19
 
     A representative sample of the produc ts in question shall be enclosed with the 
request. It might represent several modifica tions of the product on condition that the 
difference between modifications has no e ffect on the level of safety and other 
operating requirements.       Where appropriate, the designated body may request that ot her representative 
samples of the product be presented for inspection.       61. The technical documentation mu st permit an understanding of the design, 
manufacture, and performance of the product as  well as assessing its conformity to the 
requirements of this Technical  Regulation and shall include: 
      a general description of the product, including any planned variants; 
      all the documentation referred to in  Clause 53 of this Technical Regulation; 
      in the case of products for self-tes ting, the documentation and information referred 
to in Clause 56 of this Technical Regulation.       62. The designated body shall:        examine the technical documentation so as to verify that the representative sample 
of the product has been produced in confor mity with the techni cal documentation; 
       establish which elements of the sample  have been designed in conformity with the 
applicable standards from the index of na tional standards and which elements have 
not been designed on the basi s of the relevant provisi ons of the abovementioned 
standards;       perform all the necessary examinati ons and tests to inspect the application of 
national standards (if th e manufacturer has appl ied these standards); 
      perform the examinations and the tests necessary to verify whether the solutions adopted by the manufacturer meet the require ments of this Technical Regulation (if 
the standards have not been applied acco rding to Clause 8 of this Technical 
Regulation);            arrange with the applicant the loca tion at which the necessary examinations and 
tests will be carried out
. 
      63. If the representative sample of th e product conforms to the provisions of this 
Technical Regulation, the de signated body shall issue the applican t with a type-
examination certificate, which shall contain:       the name and address of the manufacturer;       the conclusions of the examination;       the conditions of validity of the certificate;  20
 
     the data needed for iden tification of the type examined; 
      The list of the technical documentation shall be enclosed to the certificate. A copy of the certificate shall be retained by the designated body. 
      If the request to issue a type-exa mination certificate is refused, the designated body 
shall provide a detailed explan ation for such a refusal. 
      The designated body shall inform th e Ministry of Health of its decision. 
      64. The manufacturer or  its authorised person shall: 
      inform the designated body that issu ed the type-examinati on certificate of all 
alterations made to the examined product,  which shall undergo additional examination 
if such alterations could effect the confor mity of the product with the requirements of 
this Technical Regulation or application conditions. Such product shall be examined 
additionally. The data of additional examina tion shall be annexed to the original type-
examination certificate;       keep safe - for at least five years from the date on which the last sample of the 
product is manufactured - copies of the type -examination certificates  together with the 
technical documentation. If th e manufacturer is unavailable , the responsibility to keep 
the technical documentation shal l be vested to the person that has placed the product 
on the market.  
     65. In module D, the conformity assessment procedures that enable the 
manufacturer or its authorised person to fulfil their commitments are described, as specified in Clause 66 of this Technical Regulation, to guarantee and declare that the 
products conform to the type specified in the type-examination cer tificate and to the 
requirements of this Technical Regulation.       66. The manufacturer must:         have a quality management system  that is approved by the designated body, a 
system of monitoring and tests of final pr oducts in line with Clauses 67-70 of this 
Technical Regulation, which shall be a subject to surv eillance according to the 
provisions of Clause 71 of this Technical Regulation. In addition, during the production and application of products included into inde x A (Annex 1), the 
manufacturer shall observe the procedures  specified in Clauses 72 and 73 of this 
Technical Regulation;       mark each product with the Nati onal Mark of Conform ity and draw up the 
Declaration of conformity (Annex 2). The National Mark of Conformity shall be 
followed with the identification number of the designated body that is responsible for 
the surveillance, as determined in Clause 71 of this Technical Regulation.       67. In order to examine the quality management system, the manufacturer shall 
submit the request to the designated body se lected at its discretion, which shall 
comprise:  21
 
     all the necessary paperwork and oblig ations, as specified in Clause 87 of this 
Technical Regulation;       the technical documentation concerni ng the approval of the type and the copy of 
the type-examination certificate, issued in line with Clause 63 of this Technical Regulation.       68. The application of the quality ma nagement system shall guarantee conformity 
of the products with the type describe d in the type-examination certificate. 
      All the elements, requirements and pr ovisions adopted by th e manufacturer for its 
quality management system must be docum ented in a systematic and orderly manner 
in the form of written policy statements and procedures. This quality management 
system documentation must enable uniform interpretation of the quality assurance 
programmes, plans, manuals and records on qu ality issues and include the information 
on:       the manufacturer’s quality objectives;       the organisation of th e business and, in particular: 
      -  the organisational structure, the re sponsibilities of the managerial staff and their 
authority where product quality is concerned; 
      -  the means of constant monitoring to achieve the appropri ate product quality and 
the efficient operation of the quality management system;  
      the inspection and quality assurance techniques at the manuf acturing stage an, in 
particular:       -  the processes and procedures which will be used, particularly as regards sterilisation, supplies, and related paperwork; 
      -  the product identification proce dures drawn up from a nd based on drawings, 
specifications and other relevant documents from each manufacturing stage;       the tests and trials to be carrie d out before, during a nd after the products’ 
manufacture, the frequency with which they will take place, the test equipment used, 
ensuring the  possibility to trace back the calibration of the test equipment. 
      69. The designated body shall audit the quality management system in order to 
determine whether it meets the requirements referred to in Clause 68 of this Technical Regulation.       The quality management system is pr esumed to conform to the provisions of the 
harmonised National Standard DSTU IS O 13485:2005 “Medical Products. Quality 
Management Systems. Regulation Require ments” (ISO 13485: 2005, IDT), with the 
exception of Clause 7.3.   22
     The inspecting commission on assessmen t of the quality management system that 
is formed by the designated body shall incl ude at least one prof essional with past 
experience in the assessment of the tec hnology of manufacturing of similar products. 
      The quality management system’s assessment procedure shall include an inspection of the manufacturer’s premises  functioning. The conclusion founded on the 
inspection results and duly substantiated deci sion on approval or de nial in approval of 
the quality management system shall be  relayed to the manufacturer in writing. 
      70. The manufacturer shall respect its  obligations concerning the maintenance of 
the approved quality management system in an appropriate a nd effective state. 
      The manufacturer or its authorised  person shall inform the designated body that 
approved the quality management system of any intention to intr oduce alterations to 
it.       The designated body shall assess the pr oposed alterations and shall take a decision 
on the subsequent compliance of the quality management system with the requirements specified in this Technical Regulation, or shall re -assess the product. 
The designated body shall also relay to th e manufacturer substantiated conclusions 
and the decision.       71. The designated body shall perfor m monitor the functio ning of the quality 
management system in accordance with th e procedure described in Clauses 94-97 of 
this Technical Regulation.  
     72. The manufacturer shall, immediat ely following completion of the control tests 
of products for laboratory diagnostics in vitro included in list A (A nnex 1), send to the 
designated body the relevant re ports detailing the results of  the tests performed on the 
final products or every batch of these products.       73. The manufacturer is permitted to place those produc ts on the market on 
condition that it does not recei ve the negative conclusion from the designated body in 
within the time-frame predetermined in th e agreement (contract), but not later than 
within 30 days following delivery of the samples to the designated body. 
      74. In module F, the conformity assessment procedures that enable the 
manufacturer to examine and to testify that  the products conform to the type specified 
in the type-examination certificate and to the requirements of this Technical Regulation are described.       The manufacturer shall take actions to the effect that the manufacturing process 
ensures conformity of the products to th e type, specified in the type-examination 
certificate, and to releva nt requirements of th is Technical Regulation. 
      Prior to the commencement of manu facturing of medical products for laboratory 
diagnostics in vitro,  the manufacturer shall, where required, prepare the 
documentation that defines the manufacturing process, including sterilisation, together 
with all current, pre-set issu es that shall be introduced to guarantee the uniformity of 
the manufacturing and, where applicable, co nformity of the products to the type  23
specified in the type-examination certificat e and to relevant requirements of this 
Technical Regulation.       The manufacturer shall mark each pr oduct with the National Mark of Conformity 
and shall draw up the Declara tion of conformity (Annex 2). 
      75. If statistical examination in line with Clause 82 of this Technical Regulation is 
not viable, the manufacturer shall perform adequate examination, investigation and 
control procedures that have been agreed  with the designated body on samples of the 
products. The procedure concerning monitoring by the designated body in line with Clauses 95-98 of this Technical Regulation shall be applied in such a case.   
      76. 
 The manufacturer shall establish and keep  up to date a systematic analysis of 
experience gained from operation of de vices after their production, and shall 
implement appropriate means to apply any necessary corrective actions. The 
manufacturer shall notify the Ministry of H ealth immediately afte r receiving the news 
in accordance with Clause 55 of this Technical Regulation. 
      77. The designated body must carry out, at the manufacturer’s choice, 
examinations and tests of every product, as  specified in Clauses 78 and 79 of this 
Technical Regulation, or examinations and te sts with the applica tion of statistical 
methods as specified in Clauses 80-83 of  this Technical Re gulation, taking into 
account of provisions of Clause 75 of this Technical Regulation. 
      78. If each product is subjected to exam inations and tests, they shall be examined 
and tested in the manner defined in the rele vant standard(s) from the index of national 
standards. Alternatively, equivalent examin ations and tests must be carried out in 
order to inspect the conform ity of every product to the type specified in the type-
examination certificate and to relevant re quirements of this Technical Regulation. 
      79. The designated body shall arrange the affixing on each tested product of its 
own identification number and shall issue th e conformity certificate on the basis of 
the tests performed.       80. The manufacturer shall provid e the designated body w ith its products for 
examination in uniform batches, and shall ta ke action to ensure the uniformity of each 
batch that is produced.       81. The designated body shall perfor m a random selection of products from each 
batch, and shall examine and test each selected product in accordance with the relevant standard(s) from the index of nati onal standards, or shall perform equivalent 
examinations and tests to inspect the confor mity of every product to the type specified 
in the type-examination certificate and to relevant requirements of this Technical 
Regulation, and shall takes a decision as to  whether the batch of products shall be 
accepted or rejected.       82. The statistical examination shal l be based on attribut es and/or variables 
stipulated by random control schemes and performance parameters that guarantee the 
high safety level and efficiency of pr oducts according to the state of the art 
technology. The random control schemes shall be established by the harmonised  24
standards from the index of national standard s, taking into account the specific nature 
of the product categories in question.       83. If the batch conforms to the established requirements, the designated body 
shall affix or shall direct the manufacturer  to affix its own identification number onto 
each product in the batch, and shall issue the conformity certificate relating to the test 
performed. All products in the batch may be put on the market, with  the exception of 
any samples that failed to conform to the established requirements.       If the batch does not conform to th e established requirements, the designated body 
or the central executive body shall take meas ures according to legislation to prevent 
the batch from being placed on the market . In the event of multiple cases of non-
conformance of batches to the established requirements, the designated body may suspend the statis tical verification. 
      The manufacturer may, on the res ponsibility of the desi gnated body, affix the 
designated body’s identif ication number during the production process. 
      84. In module H the conformity assessm ent procedures are described that enable 
the manufacturer to examine and confir m that the products conform to the 
requirements of this Technical Regulation.        The manufacturer shall mark each pr oduct with the National Mark of Conformity 
and shall draw up the Declar ation of conformity (Annex 2). The National Mark of 
Conformity shall be accompanied with th e identification number of the designated 
body responsible for monitoring the product, as  specified in Clauses 94-97 of this 
Technical Regulation. 
      85. The manufacturer shall exercise th e quality management system for the design, 
manufacturing, monitoring and testing of  the final product, approved by the 
designated body, and that is subject to surv eillance in line with  the provisions of 
Clauses 94-97 of this Technical Regulation. In addition, during the manufacturing and 
application of the products stipulated in  list A (Annex 1), the manufacturer shall 
observe the requirements specified in Cl auses 90-93, 98 and 99 of this Technical 
Regulation.       86. The manufacturer shall submit to one  of the designated bodies selected at its 
discretion the request to asse ss its quality management systems, which are applied to 
certain products. The request shall comprise:       the name and address of the manu facturer and any addi tional manufacturing 
facility covered by the quality management system;       all the necessary  information on the product or product cat egory covered by the 
procedure;      written confirmation that no such application has been submitted to any other designated body;       the documentation on the quality management system;  25
 
     an obligation to fulfil the requir ements of the quality management system; 
      an obligation to k eep the introduced quality management system adequate and 
efficient;       where applicable, the technical do cumentation concerning the type-examination 
and the copy of the type-examination certificate;       an obligation by the manufacturer to  institute and keep up to date a systematic 
analysis of experience gained from the products’ operation in the post-production 
phase and to implement appropriate meas ures to apply any necessary corrective 
actions. The obligation shall also include the notification of the Ministry of Health immediately after receiving the news about:       -  any failure of or deteriorati on to the characteristic s and/or performance 
parameters of a product, as well as any inadequacy in the la belling or the user 
instruction that might lead to, or may have le d to, the death of the pa tient or user or to 
a serious deterioration to the state of their health; 
      -   any technical or medical grounds  connected with the characteristics or the 
performance parameters of a product, that for the abov ementioned reasons lead to 
systematic recall of products of th e same type by the manufacturer. 
      87. The quality management system must guarantee the products’ conformity to 
the provisions of this Technical Regulation wh ich apply to them at every stage, from 
design to final inspection.  
      All elements, requirements and provi sions adopted and used by the manufacturer 
must be documented in a systematic a nd orderly manner and in written form as 
policies, procedures and instructions.       The documentation concerning the qual ity management system shall enable an 
unequivocal interpretation of the quality a ssurance programmes, plans, directives, 
quality protocols and, in particular, include information relevant to:  
       the manufacturer’s quality objectives;       the organisation of th e business and, in particular: 
      the organisational structure, the res ponsibilities of the managerial staff and their 
authority where quality of design and manufacture of the products is concerned;       the methods of constant monito ring the efficient opera tion of the quality 
management system and in particular its abil ity to secure the desired quality of design 
and manufacturing of products, including the rejection of s ubstandard products; 
      the procedures for monitoring and ve rifying the design of the products and, in 
particular:   26
     -  technical specifications that ha ve been applied, including standards from the 
index of national standards, re sults of the risks analysis an d descriptions of decisions 
adopted to conform to the requirements  of this Technical  Regulation, if no 
aforementioned standards have been applied;       -  methods of the design mana gement, design examin ation, processes and 
systematic measures that will be used during the product design process; 
      -  whereas the product to operate in line with the intended purpose shall be connected to the other product(s), the statem ent that it conforms to the essential 
requirements, when connected to the product( s) with characterist ics, specified by the 
manufacturer;       -   the draft of the label and, where applicable, the user instructions; 
       methods of the quality management  and quality assurance at the manufacturing 
stage and, in particular:        the processes and procedures that will be used, particularly as regards ensuring sterility, supplies and relevant paperwork; 
      the product identification proce dures drawn up from a nd based on drawings, 
technical specifications or ot her relevant documents at every stage of production; 
      the tests and trials which will be carried out at every stage of the products’ 
manufacturing (including before and afte r manufacture), the frequency with which 
they will take place, and the test equipment used; it must be possible to trace back the 
primary calibration of the test equipment.       88. The designated body must examin e the quality management system to 
determine whether it meets the requirements s tipulated in Clause 87 of this Technical 
Regulation. The quality management system sh all be assessed in the light of these 
requirements, in line with National Standard DSTU ISO 13485:2005 “Medical 
Products. Quality Management System s. Regulation Requirements” (ISO 
13485:2005, IDT), with the exception of Clause 7.3.       The inspection committee for assessing  the quality management system that is 
formed by the designated body shall include at least one profe ssional with past 
experience in the assessment of the t echnology of the production of such products. 
      The procedure for assessing the quality management system shall include an inspection of operations at the manufactur er’s premises. A conclusion based on the 
inspection results and a duly substantiated de cision to approve or reject the quality 
management system shall be sent to the manufacturer in writing.       89. The manufacturer shall respect its obligations to maintain  the approved quality 
management system in an appropriate and effective condition.       The manufacturer or its authorised  representative shall inform the designated body 
that approved the quality management sy stem of any intention to modify it.  27
 
     The designated body shall assess the proposed modifications and shall take a 
decision on the subsequent conformity of the quality management system with the 
requirements specified in Clause 87 of this  Technical Regulation or  shall re-assess it. 
The designated body shall also send its decision to the manufacturer with its 
conclusions and the reasoni ng on which they are based. 
      90. In addition to the obligations refe rred to in Clauses 86-90 of this Technical 
Regulation, the manufacturer must submit to  the designated body a request to perform 
an examination of the design of products included in list A.    
      91. The request shall make it possi ble to understand the design, manufacture and 
properties of the product and shall include  the paperwork that is necessary for 
assessment of the product's conformity to  the requirements of this Technical 
Regulation.       92. The designated body must exam ine the request and reach a conclusion 
concerning the conformity of the design w ith the requirements of this Technical 
Regulation. In the case of a positive conclu sion, a design-examination certificate shall 
be issued to the manufacturer. The designa ted body may require th e manufacturer to 
carry out additional tests or present evidence to permit an assessment of conformity with the requirements of this Technical Regulation. The certificate shall contain the 
conclusions of the examination, the conditions  under which it was performed, the data 
required for identification of the relevant design and, wher e appropriate, a description 
of the intended purpose of the product.  
     93. The submitter shall inform the designated body that issued the engineering 
design - examination certificate of all modifi cations to the examined product that shall 
undergo additional examination, if such alterations could affect the product’s conformity to requirements of this Technica l Regulation or the a pplication conditions. 
Such product shall be examined additionally. The data of additional examination shall 
be annexed to the original of the engi neering design -examination certificate. 
      94. The designated body shall audit th e quality management system’s functioning 
to inspect whether the manufacturer respects  its obligations aris ing from the approved 
quality management system.       95. The manufacturer must ensure th e possibility to carry out all the necessary 
examinations by the designated body and provide it with all the necessary 
information, including:       the documentation on the quality system;       the results of analyses , calculations, trials, etc., pe rformed on the stage of design; 
      the reports on inspections and trial re sults, data on calibrati ons, qualification level 
of the product, etc.   28
     96. The designated body shall inspect on a periodic ba sis whether the manufacturer 
correctly maintains the quality management system and shall provide the manufacturer with th e inspection reports. 
      97. In addition to a regular inspection, the designated body may carry out the inspection without warning, subject to s ubstantiated grounds. During the inspection, 
the designated body, at its discretion, may pe rform or request the manufacturer to 
perform the tests of the products. The manu facturer shall be provided with the 
inspection report and the log sheet of the tests.       98. The manufacturer shall immediat ely send to the design ated body corresponding 
reports based on the tests results of either ready products or each batch of products, if 
the products are included into list A (Annex 1). In addition, the manufacturer must 
provide specimens of the manufactured pr oducts on the conditions specified in the 
agreement (contract).       99.  The manufacturer is permitted to place those products on the market on 
condition that it does not receive the nega tive conclusion from the designated body 
within the time-frame predetermined in the agreement (contract), but not later than in 
30 days following delivery of samples to the designated body. 
      100. The products included into list A shall undergo, at the manufacturer’s choice, 
the conformity assessment according to Cl auses 84-99 (module H), or Clauses 59-64 
(module B) in conjunction with the proce dure in line with Clauses 65-73 (module D). 
      101. The products included in list B shall undergo, at the manufacturer’s choice, 
the conformity assessment according to Clauses 84-99 (module H) without the 
examination of the engineering design in  line with Clauses 90-93 and product 
specimens’ examinations in line with Clauses 98 and 99, or Clauses 59-64 (module B) in conjunction with the procedure followi ng one of Clauses 74-83 (module F) or 65-
73 (module D) without the examination of  the product specimens following Clauses 
72 and 73.       102. Products which are not included in lists A and B, and which are intended for self-testing, shall undergo - at the choice of the manufacturer - the conformity 
assessment according to Clauses 84-99 (module H) without the examination of the engineering design in line with Clause s 90-93 and product specimens’ examinations 
in line with Clauses 98 and 99, or Clauses 51-58 (module A). 
      103. Products that are not included in lists A and B and that are not intended for self-testing shall undergo the conformity assessment in accordance with Clauses 51-
58 (module A) without the examination of the engineering design in line with Clauses 
90-93.       104. The manufacturer or  its authorised person shall s ubmit an official report to the 
Ministry of Health regarding medical pr oducts intended for performance evaluation, 
irrespective of whether they ar e included in lists A or B. It shall be also guaranteed 
that the products conform to the requ irements of this Technical Regulation. 
      The report shall comprise:  29
 
     the data allowing th e identification of the product; 
      an evaluation plan for the product st ating the objective, scie ntific, technical and 
medical grounds, scope of the evaluation a nd number of products to be examined; 
      the list of laboratories or other in stitutions participating in the evaluation study; 
      the start date  and scheduled dur ation for the evaluation procedure and, for 
products intended for self-testing, the loca tion and number of the participating 
patients;       a statement that the product in quest ion conforms to the requirements of this 
Technical Regulation and that all the necessary measures have been taken in order to 
ensure the health and safety of the patient, the user and third parties. 
      105. The manufacturer must:       draw up and keep safe for at leas t 5 years the documentation that enables the 
understanding of the design specifics of th e product, its manufacturing details and 
performance parameters, including anticipat ed performance parameters, in the scope 
of the assessment of conformity to the requirements of this Technical Regulation 
possible by the central executive bodies;       undertake all the necessary actions to  the effect that the products’ manufacturing 
process ensures that their production c onforms to the specified documentation. 
 
     106. The marking of the medical products intended for the performance 
assessment is not applicable.       107. The designated body may require, s ubject to correct subs tantiation, additional 
information or data to be provided that  are necessary for the determination and 
confirmation of the evidence of  the conformity in line with the selected procedure. 
      108. The decision taken by the designated body following the procedures in line with this Technical Regulation shall be valid for not more than five years, and this term may be extended to the five years following the request, submitted in the terms specified in the contract  signed by both parties. 
      109. All paperwork and corresponden ce concerning the conformity assessment 
shall be written in Ukrainian.       110. All parties exercising the require ments of this Technical Regulation shall 
observe the established system of the info rmation access that they use in their normal 
activities, with the exception of certa in cases as stipulated by the law. 
            A n n e x  1   30
                to the Technical Regulation  
 
LIST 
of medical products for laboratory diagnostics in vitro 
 
      List A  includes reagents and reagents produc ts, including related calibrators and 
control materials:        for determining the following blood groups: ABO system, rhesus (C, c, D, E, e) anti-Kell;       for the detection, confirmation and qua ntification in human specimens of markers 
of HIV infection (HIV 1 and 2), HTLV I and II, and hepatitis B, C and D. 
         List B  includes: 
       reagents and reagen t products, including related calibra tors and control materials:  
      for determining the following blood groups: anti-Duffy and anti-Kidd;       for determining irregu lar anti-erythro cytic antibodies; 
      for the detection and quantification in human samples of the following congenital infections: rubella , toxoplasmosis; 
      for diagnosing the hereditary disease phenylketonuria; 
 
     for determining the following human infections: cytomegalovirus, Chlamydia;       for determining the following HLA tissue groups: DR, A, B;       for determining the following tumoral marker: PSA,       software, designed specifically for evaluating the risk of trisomy 21 syndrome; 
      the following device for self-diagnosis, including its related ca librators and control 
materials: device for the measurement of blood sugar.            
 
 
        A n n e x  2   31
               to the Technical Regulation 
 
 
DECLARATION 
of conformity 
 
(full name of the manufacturer or it s authorised person, who are resident s of Ukraine, or the supplier, 
_____________________________________________________________________________________________
__________  
their addresses and the code according to EDPNOU (if registered) 
_______________________________________________________________________________________________________ 
represented by 
________________________ __________________ ______________ 
                                     (posit ion, surname, first name, patronymic of the manufacturer or its authorised 
person, or  
__________________________________________________________________________________
__________  
the supplier) 
confirms that the medical 
product__________________ ________________________ 
                                                        (full name of the medical pr oduct, type, brand, model) 
__________________________________________________________________________________
__________  
produced according 
to_________________________ _______________ ___________ 
                                    (the name and the designator of the technical documentation) 
_____________________________________________________________________ 
conforms to the Technical Regulation c oncerning medical products for laboratory 
diagnostics in vitro  according to __________________________________________ 
                                                                      (the name and the designator of the normative documents  
____________________________________________________________________________________________         
                                                                        (if present)) 
     The technical documentation c oncerning the medical product following the 
requirements of the Technical Regulati on for medical products for laboratory 
diagnostics in vitro  is present. 
      The type-examination certificate (if present) ______________________________ 
                                                                              
(identification number of the type-examination 
____________________________________________________________________________________________  
certificate, its registration date, valid until, name a nd address of the designated body for certification) 
 
     The protocol of the trials of the medica l product carried out by the designated body 
for certification or under its s upervision (if required) __________________________ 
                                                                                                                   (identificat ion number of the protocol, 
____________________________________________________________________________________________  
the date of its processing, the name and addr ess of the designated body for certification) 
 
     The Declaration is drawn up under full responsibility of the 
manufacturer/authorised representative/supplier 
 
______________                _________________                _______________ (position)                              (signature)                                 (printed name)       SEAL                                                             _______________________ 
                                                                                             
(date) 
Document’s publications:  32
____________________________________________________________________-  
Ofitsijnyj Visnyk Ukrajiny of 28.07.2008-2008,N  53, p.16, Article 1773, code of the 
Act 43713/2008 -  Web-page “Legislation of Ukraine” of the web-site of the Verkhovna Rada ©1996-
2008 _____________________________________________________________________