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CABINET OF MINISTERS OF UKRAINE 
 
DECREE 
of 09/07/2008  No 621 
Kyiv 
 
On approval of the Technical Regulation on  
active medical products which are implanted  
  
     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 Technical Regulati on on active medical products which are 
implanted (hereinafter – the Technical Regulation) that is enclosed.       2. designation of the Ministry of H ealth as a responsible body for the introduction 
of the Technical Regulation as well as supervision of compliance with the requirements thereof.       3. the Ministry of Health, togeth er with the State Co mmittee 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 Decree of the Cabinet of Ministers of Ukraine                                                                              of 09/07/2008  No 621   2
TECHNICAL REGULATION 
on active medical products which are implanted 
 
GENERAL PROVISIONS 
 
     1. This Technical Regulation dete rmines the general requirements for active 
medical products which are implanted, and the safety and procedures required in 
order to confirm the compliance ther eof with the said requirements. 
      2. This Technical Regulation has been  drafted in accordance with the requirements 
of European Council Direc tive 90/385/EC of 20 June 1990 on active medical products 
which are implanted.       3. For the purpose of this Technical Regulation, terms shall have the following meanings: 
 
     1) active medical pr oduct shall mean a medical pr oduct relying on a source of 
electrical energy or any s ource of power other than th at generated by the human 
body or gravity in order for it to function.        Medical products designed to transf er power, substances, etc. from an active 
medical product to a patient without the introduction of any significant changes 
are not regarded as active medical products; 
 
2) an active medical product which is  implanted shall mean a medical 
product which is to be introduced - in part or in full, surgically or medically - 
into the human body or by me dical intervention into  a natural orifice and 
which is intended to remain in th e human body, relying on a source of 
electrical energy or another source of power other than that generated by the 
human body or gravity in order for it to function;  
 
3) custom-made active medical product which is implanted shall mean a 
medical product specifically manufact ured in accordance with a written 
prescription of a physician who is so lely responsible for identifying the 
specific design characteristics and that  is only intended to be used by the 
named patient;  
      A mass-produced medical product,  the construction of  which has been 
adapted to satisfy individual requirement s of the practicing medical physician, or 
any other user, shall not be regarded as a custom-made active medical product. 
      4) active medical product whic h is implanted intended for clinical 
investigation shall mean any active medical product which is implanted and 
intended for use by a qualified specialist physician during clinical investigations, 
identified in DSTU 4569-1- 2:2006 “Clinical In vestigations of Medical Products 
for Humans” (ISO 14155-1:2003, MOD);         5) Putting into service shall mean  the readiness of an active medical product 
which is implanted for first use and for an intended purpose;   3
6) placing on the market shall mean the fi rst appearance of an active medical product 
which is implanted, with the excepti on of products intended for clinical 
investigations, for the purpose of distribut ion and/or use on the Ukrainian market, 
irrespective of whether the produc t is brand new or modified.  
      Other definitions shall be used in the 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)       4. Requirements specified by this Technical Regulations are mandatory for: 
      manufacturers of active me dical products which are implanted; 
      persons – residents of Ukraine - who are authorised by the manufacturer 
(hereinafter – authorised person);       persons  responsible for placing active medical product which are implanted on the market or bringing them into service if th e manufacturer or authorised person do not 
exercise activities on the territory of Ukraine (hereinafter – person who placed active medical products which are implanted on the market or brought them into service); 
       central executive authorities and th eir bodies functioning in technical regulation 
and supervision the safety of  active medical products which are implanted (hereinafter 
– central executive bodies); 
 
     designated bodies for assessing confor mity of active medica l product which is 
implanted that conforms to 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 Implementation of Procedure of Appoint ment of Bodies Assessing the Conformity 
of Products, Processes and Services to Requirements of Technical Regulations” 
(Ofitsijnyj Visnyk Ukrajiny, 2007, No 6, p. 223)  (hereinafter – designated bodies). 
       5. Active medical products which are implanted intended for introduction of the 
medicine into the human body is covered by this Technical Regulat ion, as well as by 
the Law of Ukraine “On Medicines” ( 123/96-VR) according to the requirements 
concerning the medicine.       If the active medical product which is  implanted and the medicine constitute an 
integral whole and the medical product cannot be used again, such product shall be a 
subject for regulation by Law of Ukra ine “On Medicines” (123/96-VR).   
      Requirements established in this Tec hnical Regulation cover the parameters of the 
medical product, related to its safety and effectiveness only. 
      In case when a substance, which is an  integral part of an  active medical products 
which are implemented, can be used as a me dicine identified in the Law of Ukraine 
“On Medicines” (123/98-VR) a nd that is capable of effecting an auxiliary action on  4
human body in relation to the action of an active medical product which is implanted, 
then safety, quality and effectiveness of this medicine shall be verified taking into account of the expected purpose of the pr oduct in line with Law of Ukraine “On 
Medicines” (123/96-VR).  
      6. Electromagnetic compatibility of active medical products which are implanted 
shall be regulated by DSTU IEC 60601-1-2-2001  “Medical Electrica l Equipment. Part 
1. General Requirements for Safety. 2. Collateral Standard. Electromagnetic 
Compatibility. Requirements and Te sts” (IEC 60601-1-2:1993, IDT).  
      The Technical Regulation in part  concerning confirmati on of compliance of 
electromagnetic compatibility does not cover active medical products which are 
implanted.       7. Placing on the market  and putting into service of active me dical products which 
are implanted that are covered by this Tec hnical Regulation shall be permitted if this 
does not endanger the life and health of pa tients, users and othe r persons, on condition 
that correct installation, servici ng and application are provided. 
      8. The manufacturer or authorised pe rson, or the person that brought/is responsible 
for putting an active medical product which is  implanted into service or placing it on 
the market shall be held responsible for the failure to implement all procedures of conformity assessment of safety requirement s specified in this Technical Regulation, 
in accordance with the law.       Such requirements also concern lega l entities and natural persons that assemble, 
pack, process, modify and/or provide mark ings for one or more prepared medical 
products.       The abovementioned requirements do not  cover persons that are not manufacturers 
but supply medical products that have alre ady been placed on the market following 
their intended application for the specified patient.       9. If an active medical product which is  implanted conforms to the requirements of 
the national standards, from the index of su ch standards that are officially published 
by the central executive bodies on standardis ation, voluntarily applied in full or in 
part, then this is proof of compliance of  the product with this Technical Regulation 
and the product shall be considered to be in  conformance with the requirements of this 
Technical Regulation.       For the purpose of this Technical Regul ation, the index of national standards shall 
additionally include that submitted by th e Ministry of Health monographs of 
European Pharmacopoeia concerning surgic al sutures and inte ractions between 
medicines and materials that are used in active medical products which are implanted 
that contain such medicines.        10. Prior to the placing on the market or putting into service of an active medical 
products which is implanted, th e National Mark of Conformity shall be affixed thereto 
or to the packaging thereof and/or placed in the docu mentation, notifications or 
instructions that accompany the product, with the exception of custom-made active  5
medical products which are implanted and products intended for clinical 
investigations,  in accordan ce with Decree of the Cabinet of Ministers of Ukraine of 
29/11/2001 No 1599 (159902001-p) “On Approval of Description and Rules of 
Application of the National Mark of C onformity” (Ofitsijnyj Visnyk Ukrajiny, 2001, 
No 49, p. 2188).       Application of the National Mark of Conformity shoul d be made in accordance 
with the requirements set out in Decree of the Cabinet of Ministers of Ukraine of 07/10/2003 No 1585 (1585-2003 – p) “On Appr oval of Technical Regulation of 
Modules of Conformity Assessment and Re quirements to Marking with the National 
Mark of Conformity,- that are Applied in  Technical Regulations ” (Ofitsijnyj Visnyk 
Ukrajiny, 2003, No 41, p. 2175).       11. Presence of the National Mark of Conformity on active medical products 
which are implanted indicates that legal en tity or natural pers on who has performed 
marking or who is responsible for that action, has had checked and testifies to 
conformity of medical products to require ments of this Technical Regulation, that 
cover those products, and that products have passed proper procedures of conformity 
assessment.       12. If active medical products which are implanted fall within the scope of other technical regulations that stipulates the marking thereof with the National Mark of 
Conformity, then the medical products shall also conform to the requirements of those 
technical regulations. Confor mity of an active medical product which is implanted 
with all such technical regulations shall be a condition for the marking thereof with 
the Mark. 
 
     Where one or several technical regulati ons stipulates the right  of the manufacturer 
to choose the method of conf irmation of compliance, marking with the National Mark 
of Conformity signifies conformity only w ith those technical regulations that have 
been used by the manufacturer. In such  a case, documents, notifications and 
instructions that are enclos ed to active medical products  which are implanted shall 
incorporate references to the technica l regulations that have been used. 
      13. If it is discovered that the Nationa l Mark of Conformity is  used in violation of 
the requirements of this Tec hnical Regulation, then the manu facturer or its authorised 
person or the person that placed the activ e medical products which are implanted on 
the market or put them into service shall take action to ceas e such violation in order to 
ensure the medical products are brought into conformity w ith the requirements of this 
Technical Regulation and to confirm such compliance according to established order.       In the case of violation of th e law, central executiv e bodies shall undertake 
appropriate action to restrict or ban su ch medical products from being placed on the 
market or to withdraw them from the market. 
      Any decision made regarding this Tec hnical Regulation in respect to the restriction 
or banning of active medical products whic h are implanted from being placed on the 
market or putting them into service, or thei r withdrawal from the market, shall contain 
a clear list of the reasons on which the deci sion was based.  The concerned party shall  6
be informed immediately of this decision and of the permitted timeframe within 
which corrective actions towards the iden tified violations should be taken. 
       14. Following the results of the app lication of active medical products which are 
implanted, the Ministry of Health shall perform constant monitoring and assessment 
of any information about those products that  have been placed on the market or put 
into service, and concerning:       failure or degeneration of parameters  and/or properties of active medical products 
which are implanted, any misleading informa tion on the label or in the user manual  
that could result or has already resulted in death or deterioration to the of patients, 
users and other persons;       technical or medical r easons for alteration of paramete rs and/or properties of active 
medical products which are implanted that 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 to carry out analyses. 
      15. If it is revealed that active medi cal products which are im planted with correct 
installation, servicing and app lication provided are still likely to endanger the health 
and safety of patients, users and other pers ons, all possible actions shall be taken to 
withdraw such products from th e market or to ban or to re strict them from being put 
into service, in accordance with the law. 
 
Requirements concerning the design a nd manufacturing of active medical 
products which are implanted 
 
     16. Implantable active medical products shall be designed and produced so as to minimise any risks to the health of pa tients, users and other persons where the 
products are implanted under appropriate c onditions and for the intended purposes.  
      17. Implantable active medical products  shall be designed a nd manufactured so as 
to perform the following functions:        preventive measures, diagnosti cs, treatment, monitoring and relieving the 
condition of the patients who are sick, injured or disabled  as well as compensation for 
organ failure or physical disability;       investigation, replacement or modifi cation of the structure (anatomy) of organs, 
tissues or physiological processes;       monitoring the pr ocess of fertilisation. 
      18. Implantable active medical produc ts shall be designed, produced and packaged 
so that their technical parameters and properties do not change  during storage and 
transportation.    7
     19. If the technical characteristics a nd properties of an impla ntable active medical 
product change during storage or use even  though it has been correctly installed, 
serviced and used with observance of  the storage period under the conditions 
specified by the manufacturer, such changes sh all not continue to such an extent that 
the life and health of patients, us ers and other persons are at risk.  
      20. The manufacturer or its authorised  representative shall be  responsible for the 
basic principles of integrated safety when designing and constructing implantable 
active medical products.       21. Implantable active medical products that are supplied sterile, shall be designed, 
produced and sterilised in accordance with  the approved methods under the correct 
conditions and packaged in disposable packaging and/or fo llowing corresponding 
procedures that ensure their sterility during transportation and storage until the packaging is opened immediat ely prior to implantation. 
      22. Constructing and packaging of im plantable active medical products shall be 
carried out in a manner that will eliminat e or minimise any possible risks that may 
arise in connection with:        their physical propert ies, including dimensions; 
      use or sources of en ergy. If the functioning of the pr oduct depends on a source of 
electrical energy, specia l attention shall be paid to th e insulation, wiri ng and heating 
of the product;  
     environmental conditions, such as magnetic fields, external electrical interference, 
electrostatic discharges, pr essure and pressure fluctu ation, acceleration, etc.  
      medical intervention,  especially when defibrilla tors or high-frequency active 
implantable surgical products are used; 
      ionising radiation, emitted by radioactive substances that are contained in an 
implantable active medical product, with the observance of appropriate technical 
safety arrangements.  
     inability to service or to calibrate due  to excessive wiring, ageing of materials used, 
excessive emission of heat by the product  or reduction in accuracy of a testing and 
control device .       23. Implantable active medical products shall be designed and produced in such a 
way as to secure technical parameters and productivity in accordance with the general 
requirements specified in Clauses 16 – 21 of  this Technical Regul ation, including the 
following special characteristics:        selection of materials used, es pecially in view of their toxicity; 
      compatibility of materials used with  human tissues, cells and fluids, taking into 
account the expected purpose of th e implantable active medical product; 
  8
     compatibility of implantable active me dical products with substances the that they 
transfer;       quality of connecting terminals w ith the observance of appropriate safety 
requirements;       reliability of energy sources;       proper tightness;       correct functioning of operating, pr ogramming and monitoring systems, including 
software;        24. Implantable active medical pr oducts and parts thereof (where required) 
shall be marked to make it possible to identify them and to intervene, where necessary, if life and/or health are enda ngered by such medical products or parts 
thereof. 
 25. Implantable active medical product s must bear a code by which they 
and their manufacturer can be unambi guously identified (particularly with 
regard to the type of product and year of  manufacture).  This code, if necessary, 
must be readable without the need for a surgical operation.  
 26. If the implantable active medical product and/or parts thereof are subject 
to instructions necessary fo r the operation of the product or  to operating or adjustment 
parameters using indicating systems, such  information must be understandable by the 
user and the patient.   
     27. The packaging of the active medical product which is implanted must 
bear legible and permanent marking for the period of it operation and storage 
that contain the following details:       1) on individual (sterile) and sales/transporting packaging:  
      the name of the product;       the words “exclusively for clin ical investigations” on active medical 
products which are implanted that are in tended for clinical investigations; 
      the wording “custom made product ” on active medical products which are implanted that are custom made;       a declaration that the product is in a sterile condition; 
      the month and year of the manufacture;       the expiry date for implanting a product safely;        2) on the individual  (sterile) packaging only: 
      the methods of sterilisation;   9
 
     the indication of the packaging sterility;        the surname and the signature of the manufacturer;        3) on the sales/tr ansporting packaging only: 
      the address of the manufacturer;       the data on the intended purpose of the product;  
      the characteristics for its use;        the conditions for transpor tation and storage of the product .  
      28. When placed on th e Ukrainian market, each active medical product which 
is implanted must be accompanied with in structions for use giving the following 
particulars:        the year of the marking with  the National Mark of Conformity;  
      the information marked on individual (sterile) and sales/transporting packaging, with the exception of the in formation concerning the month/year of 
manufacture and the expiry date for implanting a product safely;   
      data about performances in acc ordance with requirements for design and 
manufacturing, procedures of conform ity assessment, design and construction 
and possible undesirabl e side-effects;  
      the necessary technical data a llowing the physician to select a suitable 
active medical product which is implante d and the corresponding software and 
accessories;       information about the use allo wing the physician and, where appropriate, 
the patient to use the active medical pr oduct which is implanted, its accessories 
and software correctly, as well as information on the type, scope and time frames for operating controls, and in formation about it erative functional 
control and maintenance arrangements;        requirements that should be adhere d to in order to avoi d risks in connection 
with the implantation of the product;        information regarding the risks of reciprocal interference in connection with 
the presence of the activ e medical product which is implanted during specific 
investigations or treatment;        instructions in the event of the sterile pack being damaged together with 
details of appropriate met hods of re-sterilisation;  
  10
     information that an active medi cal product can be reused only if it is 
capable of performing in accordance w ith the basic requirements under the 
responsibility of the manufacturer.        The instruction manual shall al so include details about possible contra-
indications and the precautions to be  taken. These details shall cover in 
particular:        information about service life and the energy sources;         precautions to be taken should changes occur in the active medical product's performance;        precautions to be taken regarding exposure to magnetic fields, external electrical influences, electrostatic discharg es, pressure or variations in pressure, 
acceleration, etc.;       information regarding the medici nal purpose of the active medical product 
which is implanted;       29. Confirmation that the active medical product which is implanted 
conforms to the requirements in respect  of characteristics a nd performances, in 
accordance with requirements of design and manufacturing, referred to in 
Clauses 16 – 29 of this Technical Regula tion, in appropriate conditions of use, 
and the assessment of the side effects or undesirable effects must be based on 
clinical data established in accord ance with DSTU 4569-1-2:2006.  "Clinical 
Investigations of Medical Products  for Human Subjects” (ISO 14155-1:2003, 
MOD).   
 
Procedures for conformity assessment 
 
     30. Assessment of conformity of ac tive medical products which are implanted, in 
accordance with this Techni cal Regulation, shall be pe rformed with the use of 
modules of conformity assessment procedures or combinations thereof as specified in 
the Decree of the Cabinet of Ministers of Ukraine of 07/10/2003 No 1585 (1585-
2003-p) “On Approval of the Technical Regulation of Conformity Assessment 
Modules And Requirements Towards Marking with the National Ma rk of Conformity 
that Are Used in Technical Regulations ” (Ofitsijnyj Visnyk Ukrajiny, 2003, No 41, p. 
2175; 2007, No 1, p.31) taking into account th e specifics of application of active 
medical products which are implanted as follows:  
1) for module B (verification of type): 
      the technical documentation that is submitted with an application, with the exception of the documentation identified in Clause 28 of the Tec hnical Regulation of 
Conformity Assessment Modules And Re quirements Towards Marking with the 
National Mark of Conformity that Are Us ed in Technical Regul ations” approved by 
the Decree of Cabinet of Ministry of Ukraine of 7/10/2003, No 1585 (1585-2003-p), 
shall include:    11
     - design drawings, methods of  manufacture and sterilisation envisaged, 
diagrams of parts, bl ocks, circuits, etc.;  
     -  the descriptions and explana tions necessary for th e design drawings, 
diagrams of parts, circuits and operation of the product;      -  results of design calculations, ri sk analyses, investig ations and technical 
tests carried out;        -  a statement that identifies whether or not the product incorporates, as an integral part, a substance as referred to in  Clause 5 of this Technical Regulation, 
and results of trials;      -  the data of clinical tests ca rried out in accordan ce with DSTU 4659-1-
2:2006 “Clinical Investigati ons of Medical Products for Human Subjects” (ISO 
14155-1:2003, MOD).;       -  the draft label and user manual.       If an active medical product which is  implanted contains, as  an integral part, a 
substance in accordance with Clause 5 of  this Technical Regulation, the designated 
body, prior to making the decision on issuing the type conformity certificate, shall 
receive an explanation from the Ministry of H ealth in respect to the application of this 
substance together with the product.       The Ministry of Health shall be informed by the designated body of the decision 
that is taken. 
      If the issuing of the certificate of type verification is re fused, the designated body 
shall provide an explanation of such a decision in writing. 
      The manufacturer or its authorised  person shall inform the designated body that 
issued the certificate of veri fication of type of all altera tions to the approved product 
that must undergo additional verification, if those alterations may influence the 
conformity of the product to the require ments of this Technical Regulation or 
conditions for use of active medi cal products which are implanted. 
      Data following the additional veri fication shall be annexed to the original 
certificate of type verification of ac tive medical product which is implanted. 
      The manufacturer or its authorised pers on shall keep copies of certificates of type 
verification and any annexes together with technical documentation for at least 5 
years following the manufacturing of th e last active medical product which is 
implanted.       If the manufacturer or its authorised person is not available, the responsibility to 
keep the technical documentation shall be vested on the person who placed the active medical product which is implanted on the market;   12
     2) for module D (ensuring production quality) – where this module is applied in 
conjunction with module B, the manufacturer or  the authorised pers on that fulfils the 
obligations in accordance with this Techni cal Regulation shall guarantee and declare 
that active medical products which are implan ted conform to the type specified in the 
certificate of type verification and with the requirements of this Technical Regulation.  
      The manufacturer or its authorised person shall mark each active medical product which is implanted with the National Ma rk of Conformity and shall draw up a 
declaration of conformity, following the attached form. 
       The National Mark of Conformity shall be accompanied w ith the identification 
number of the designated body.       The manufacturer shall have an approved by the designated body system of quality 
management of production, control and test ing of active medical products which are 
implanted that shall be a subject to supe rvision by the designated body in accordance 
with the law.       A request for evaluation of quality ma nagement system for active medical products 
which are implanted submitted to the designated body, with the exception of the information identified in Clause 41 of the Technical Regula tion of Conformity 
Assessment Modules And Requirements Toward s Marking with the National Mark of 
Conformity that Are Used in Technica l Regulations” approved by the Decree of 
Cabinet of Ministry of Ukraine of 7/10/2003, No 1585 (1585-2003-p), shall include:  
      the name and location of the ma nufacturer and its authorised person; 
 
     the necessary information about  product or category of active medical 
products which are implanted, covered by the quality management system; 
      written confirmation that the reques t has not been submitted  to an alternative 
designated body;       the quality management system documentation;       an undertaking to respect the oblig ations arising from the approved quality 
system;       an undertaking to maintain the ap proved quality system in such a way that it 
remains adequate and efficacious;       the technical documentation for ve rified type and copy of the certificate of 
the type verification;       an undertaking by the manufacturer  to establish and frequently update a 
systematic analysis of use of activ e medical products which are implanted 
following their manufacturing and placing on the market and take appropriate 
steps to ensure any necessary corrective actions are taken;   13
     All the elements, requirements and provisions adopted by the manufacturer 
for quality management system, shall be systematically and orderly documented 
in the form of written programme policies and procedures;       The quality management system documentation must enable an unequivocal 
interpretation of the quality assurance programmes, plans, manuals and quality protocols and shall include the information about:       the manufacturer’s object ives with regards to quality; 
      the organisation of th e business and, in particular: 
      - the organisational structures, th e responsibilities and authority of the 
managerial staff in respect to the quality of the activ e medical products which are 
implanted;       - the methods of constant monitori ng to ensure the desi red quality of active 
medical products which are implanted and effective operation of quality management system is achieved;       the verification and quality assuran ce at the manufacturing st age, in particular: 
      - processes and procedures used, methods of sterilisation, supplies and the 
relevant documentation;       - the procedures of identificatio n of the product, developed and updated from 
the data from drawings, specifications and other relevant documents at every stage 
of manufacture;       examinations and trials to be carr ied out before, during an d after the production 
of active medical products which are im planted, the frequency with which they 
will take place, the equipment used for testing, ensuring the availability of 
calibration of testing equipment to its primary values.            The designated body shall assess quality management system so as to determine its compliance with the related requirements.            The quality management system shall be deemed adequate to the specified requirements, if it is introduced into the manufacturing process in accordance with the 
provisions of DSTU ISO 13485:2005 “ Medi cal Products. System of Quality 
Management. Regulation Requirements. (I SO 13485:2003, IDT)”, w ith the exception 
of Clause 7.3; 
 
    The manufacturer or its authorised person shall keep for at least five years 
following the production of last active medical product which is implanted and submit if requested by the central exec utive authorities and their bodies:  
      the declaration of conformity;       product and quality management system documentation;  14
 
    the documentation regarding alterati ons to the quality management system; 
     the  decisions and reports of the designated body; 
 
     3) for module F (products inspect ion) – where this m odule is applied in 
combination with module B, the manufacturer  or its authorised person shall inspect 
and confirm that an active medical product which is implanted conforms to the type 
identified in the certificate of type verification and the requirements of this Technical Regulation.       The manufacturer shall ensure c onformity of the produc tion process to the 
certificate of type verifi cation and requirements of this Technical Regulation. 
      Prior to production of active medical products whic h are implanted, the 
manufacturer shall prepare the document ation relating to th e production process, 
including methods of sterilisa tion as well as all other agreed  provisions that should be 
introduced so as to guar antee uniformity of production and, where necessary, 
conformity of active medical products which ar e implanted to the type specified in the 
certificate of the type verification, as well as to the related requirements of this Technical Regulation.       The manufacturer or its authorised person shall mark each active medical product which is implanted with the National Ma rk of Conformity and shall draw up a 
declaration of conformity, following the attached form. 
 
     The Declaration of conformity shall be drawn up for the certain quantity of 
produced active medical products whic h are implanted (batch, series). 
      The examinations and trials of ev ery product shall be carried out in accordance 
with the appropriate national standard(s) or  equivalent testing for verification of 
conformity of every active medical product wh ich is implanted shall be carried out in 
accordance with the certificate of type verifi cation and requirements of this Technical 
Regulation.       The designated body shall mark or issu es an order in respect  to the marking with 
the identification number of every verified  active medical product which is implanted 
and shall issue the certificate of conformity on the basis of the testing performed.  In 
some cases, the manufacturer or its authoris ed person may mark th e products with the 
identification number during the production process under the responsibility of the 
designated body.       Statistical verification for active me dical products which are implanted shall be 
performed in the following order:       the manufacturer shall present th e designated body with products of every batch 
and ensure that every produced batch is homogeneous;       the designated body shall perform a random sample selection of active medical products which are implanted from every batch, examine and test every sampled  15
product in accordance with appropriate national standa rd(s) or shall carry out 
equivalent tests to verify the conformity to the type described in the certificate of type 
verification, and requirements of this Tec hnical Regulation and shall make a decision 
to accept or to reject the batch of products; 
      Statistical control shall be carried out on the basis of a lternative attributes, 
entailing a sampling control with the following characteristics:       - a level of quality, that corresponds to  a probability of acceptance of 5 percents , 
with a non-conformity percentage  of between 0.29 and 1 percent; 
      - a limit of quality that corresponds to a probability of acceptance of 5 percent, 
with a non-conformity percentage  of between 3 and 7 percent. 
      The sampling method shall be esta blished by national sta ndards, taking into 
account the specifics of the product category in question; 
      Where the batch conforms to the established requirements, the designated body shall mark or accordingly instruct the manuf acturer to mark the identification number 
of every active medical product which is im planted of the batch and shall draw up a 
certificate of conformity on the basis of the tests carried ou t. All of the products from 
such a batch may be placed on the market, with the excepti on of those products in the 
sample that were found not to be in conf ormance with the established requirements. 
      In cases in which the batch does not conform to the established requirements, the 
designated body or central executive body shal l take steps in accordance with the law 
to prevent this batch from being placed on the market. In the case of multiple non-
conformities of the batches to the establ ished requirements, the designated body may 
cease statistical verification.       The manufacturer shall keep for at le ast five years following the production of last 
product and submit if requested by the central executive bodies:  
      the declaration of conformity;       the technical documentation concer ning the production pro cess and methods of 
sterilisation;      the certificates of conformity of the batch; 
     the certificate of  the type verification; 
      4) for module H (comprehensive quali ty assurance) – for the requirements of 
this Technical Regulation module H shall be  applied by itself, not in combination 
with other modules.       During the conformity assessmen t of active medical products which are 
implanted according to the requirements of module H of this Technical Regulation, 
the manufacturer guarantees and declares  that the products conform to the 
requirements of this Technical Regulation.  16
 
     The manufacturer shall mark each activ e medical product which is implanted with 
the National Mark of Conformity and sha ll draw up the declaration of conformity, 
following the attached form.       The National Mark of Conformity shall be accompanied with the identification 
number of the designated body.       The manufacturer shall have a quality management system for designing, 
production, control and testing of the final products, approved by the designated body, 
which shall be a subject to s upervision by the designated body. 
      The quality management system introduced into the manufacturing process, shall guarantee conformity of active medical products which are implanted to the 
requirements of this Technical Regulation.       A request submitted to the designat ed body for evaluation of quality management 
system of active medical products which are implanted, except for the information, 
identified in clause 41 of the Techni cal Regulation of C onformity Assessment 
Modules And Requirements Towards Marking with the National Ma rk of Conformity, 
that Are Used in Technical Regulations ” approved by the Decree of Cabinet of 
Ministry of Ukraine of 7/10/2003, No 1585 (1585-2003-p), shall include:  
      the name and location of the ma nufacturer or its authorised person; 
      the necessary information about the product or categor y of active medical 
products which are implanted covere d by the quality management system; 
      written confirmation that applicati on had not been submitted to an alternative 
designated body;       the quality management system documentation;       an undertaking to respect the oblig ations arising from the approved quality 
management system;       an undertaking to maintain the approved quality management system in such a way that it remains adequate and efficient;       the technical documentation for ve rified type and copy of the certificate of 
the type verification;       an undertaking by the manufacturer to establish and keep continually update 
a systematic analysis of the use of ac tive medical products which are implanted 
following their manufacturing and placing on the market and to take appropriate 
steps to ensure any necessary corrective actions are taken. 
      All the elements, requirements and provisions adopted by the manufacturer 
for the quality management system shall be systematically and orderly documented in the form of written programme policies and procedures;  17
 
     The quality management system documentation must enable an unequivocal 
interpretation of the quality assurance programs, plans, manuals and quality protocols and shall include the information concerning:       the manufacturer’s object ives with regards to quality; 
      the organisation of th e business and in particular: 
      - the organisational structure, th e responsibilities and authority of the 
managerial staff concerning the quality of the active medical products which are 
implanted;       - the methods of constant monitori ng to ensure the desi red quality of active 
medical products which are implanted, and effective operati on of the quality 
management system are achieved;       the procedure for monitoring and insp ection of the product designing state, and 
in particular:       - the technical specifications, includi ng the standards applied from the index of 
national standards, results of  the risk evaluations, desc riptions of the decisions 
taken to observe the requirements of th is Technical Regulation, if aforementioned 
standards have not been applied;        -  methods to manage the design, design examination, processes and systematic 
actions to be employed du ring the product development; 
      -  confirmation that the product c onforms to the requirements when it is 
connected to the product(s) with characteri stics identified by th e manufacturer, if 
the active medical product which is implan ted according to its intended use is 
connected to other product(s);       -  the notification as to whethe r or not the active medical product which is 
implanted incorporates, as an integral part , a substance as referred in clause 5 of 
this Technical Regulation, and resu lts of the trials carried out; 
      - the clinical data in acco rdance with DSTU 4 659-1-2:2006 “Clinical 
Investigations of Medical Products for Humans”; 
 the draft of the label and, wher e required, of the user manual; 
 the verification and methods of quality a ssurance  at the manufacturing stage, in 
particular:      - the processes and procedures, whic h are used, methods of sterilisation, supply 
and the relevant documentation;   18
    - the procedures of id entification of product, devel oped and kept up-to-date from 
the data from drawings, specifications and other relevant documents at every stage 
of manufacture;      the examinations and trials to be carried out before, during and after production 
of active medical products which are im planted, the frequency with which they 
shall take place, the equipment used fo r testing, ensuring the availability of 
calibration of testing equipment to its primary values.       The designated body shall undertake the assessment of the quality management 
system to determine its compliance with  the requirements of DSTU ISO 13485:2005 
“Medical Products. System of Quality Ma nagement. Regulation Requirements. (ISO 
13485:2005, IDT)”, except for clause 7.3.       The manufacturer or its authorised  person shall keep for at least five years 
following the production of last active medical product which is implanted and submit to the central executive bodies at their request, the following:       the declaration of conformity;       product and quality management system documentation;       the documentation regarding altera tions to the quality management system; 
      the decisions and reports of the designated body; 
 
     31. In addition to the requirements of sub-clause 4 of Clause 30 of this 
Technical Regulation, the manuf acturer or its authorised  person may submit to the 
designated body the request for the examina tion of the engineering design of active 
medical product which is implanted.       32. The designated body, following th e conclusions of examination of the 
request, shall make a decision with regard s to the conformity of the engineering 
design to the requirements of this Technical Regulation. In case of a positive resolution, a requestor shall be issued with  the certificate of the examination of the 
engineering design. The designated body may ask for additional tests to be carried 
out or for proof to be pr esented in order that the conformity assessment in 
accordance with this Techni cal Regulation can take pl ace. The certificate shall 
contain the conclusion of the examination, conditions of its validity, the data required for identification of the approve d engineering design, and, if required, 
description of intended purpose of the product.  
 
     If the active medical product which is implanted contains, as an integral part, a substance that can be used separately as a product, which is capable of effecting an 
auxiliary action on human organism in rela tion to action of an active implantable 
product, than the designated body shall r eceive an explanation from Ministry of 
Health regarding the use of such substance.   19
     The decision of the designated body sha ll take into account th e concept, elaborated 
during consultations, and shall inform the public health central executive body of the 
result.       33. The manufacturer or its authorised  person shall inform th e designated body that 
issued the certificate of th e engineering design examinati on of any alterations in the 
approved design. If those altera tions may affect the conform ity of the approved design 
to the requirements of this Technical Regulation, or condi tion of use of active medical 
product which is implanted, further approval shall be received from the designated body and annexed to the origin al certificate of the engineering design examination. 
      34. Active medical products which ar e implanted that are not custom made or 
intended for clinical investigations, shal l undergo conformity assessment at the 
manufacturer’s discretion,  according to m odule H or module B in conjunction with 
modules D, or module F.       35. The manufacturer or its authoris ed person shall institute and keep up-to-
date the systematic anal ysis of use of active medical products which are 
implanted following their manufacturing a nd take appropriate steps to ensure 
any necessary corrective acti ons are taken with regards to quality and safety of 
use of active medical products which are implanted.       36. The manufacturer or itsauthoris ed person must inform the Ministry of 
Health immediately after they are notified about:       1) any failures or deterioration of pe rformance levels and/or working standards of 
the active medical product which is implanted as well as any inadequacy in the label 
and user’s manual , that may have caused or may cause death or essential health 
deterioration of the patient or the user;       2) any technical and medical precau tions, concerning performance levels or 
working standards of the active medical product which is implanted, that because of reasons, determined in sub-clause 1 of this clause, shall result in systematic recall of such products by the manufacturer.       37. During the conformity assessm ent procedure of active medical products 
which are implanted, the manufacturer and/or designated body shall take into 
account the results of all assessments and ve rifications that have been undertaken 
in correspondence with this Technical Regulation at the intermediate stage of production.       38. The designated body may request a ny additional information or data, needed 
to determine conformation to the selected procedure.       39. The period of validity of th e decision made by the designated body in 
accordance with procedures of modules B and H, shall not exceed five years and 
may be extended for further five years, following the application submitted within the period stipulated in the ag reement, signed by both parties. 
  20
     40. The conformity assessment documentation and correspondence shall be 
written in Ukrainian.  
Placing on the market and putting into service of custom ma de active medical 
products which are implanted. 
  
     41. When placing custom made activ e medical products which are implanted on 
the market or putting them into service, th e manufacturer shall dr aw up a notification, 
containing:          the data necessary for iden tification of the corresponding product; 
      the statement that this product is pr escribed for use by the specified patient only; 
      the surname of a physician or other authorised person that issued the prescription 
for that product, and th e name of the clinic; 
     the particular parameters of the product according to the relevant medical 
prescription;       confirmation that the prescribed product co nforms to the requ irements of this 
Technical Regulation and, if certain re quirements are not fully satisfied, the 
specification of these requirements and appropriate explanations.       The marking of the custom made active medical products which are implanted 
with the National Mark of Conformity is not applicable. 
 
     In addition, the manufacturer shall draw up and preserve for five years the paperwork that shall enable an understa nding of the engineering design of the 
product, its production and working paramete rs, including the ones expected, in the 
detail that will allow assessing conform ity to requirements of this Technical 
Regulation.       The manufacturer shall take all actions necessary to ensure that the manufacture of products corresponds to the paperwork.       42. The list of custom made active medical products which are implanted shall be 
submitted to the Ministry of Health by the manufacturer.  
Specifics in placing on the market and putting into service of active medical 
products which are implanted inte nded for clinical investigations 
 
     43. In order to place on the market and put into service active medical products 
which are implanted, intended for clinical investigations, the manufacturer or its 
authorised person shall draw up a notification containing:       the data needed for the product identification;       the investigations’ program, specify ing its objectives, scie ntific, technical or 
medical reasons, the scope and quantity of products;   21
 
     the conclusion of the ethics committ ee and the description of studied aspects; 
      the surname of the practicing physicia n or other authorised person, and the name 
of the clinical institution that is responsible for the investigations;       the data regarding the location, commencement date and planned duration of 
investigations;      the data regarding conformity of the product to the requirements, except for aspects 
in conjunction with investigations, and that  for these aspects all necessary steps are 
taken to ensure safety and health of the patient.       In addition, the manufacturer shall draw up and preserve for five years for 
submission to the central executive author ities, at their request, the following 
paperwork:       the general de scription of the product; 
      the technical design drawings, an ticipated methods of production, methods of 
sterilisation, sche mes of parts, blocks and circuits; 
      the descriptions and comments, e ssential for understanding of said drawings, 
schemes and operation of the product;       the conclusions of risk analysis a nd application in full or  partially of national 
standards, as well as summaries  of the decisions taken in order to implement the 
requirements of this Technical Regulati on, if standards are partially applied; 
      the results of design calculations and completed inspections or technical trials, etc. 
      The marking on the active medical products which are implanted intended for 
clinical investigations with the National Mark of Conformity is not applicable.  
      The manufacturer shall take necessa ry actions to ensure  production of medical 
products in accordance with the abovementioned documentation.       The manufacturer shall issue a permission to inspect the assessment of 
effectiveness of abovementioned actions.       44. The manufacturer shall notify Minist ry of Health of the conducting of relevant 
clinical investigations.       45. The manufacturer is permitted to  commence clinical investigations, using 
medical products after 60 da ys following the notificati on about conducting of such 
investigations, unless during this  period the Ministry of Heal th issued a decision to the 
contrary.        The Ministry of Health may sanc tion the commencement of relevant clinical 
investigations by the manufacturers during the period of 60 days, provided  22
ethics commission issues a positiv e decision regarding the proposed 
investigation programme. 
      46. Clinical investigati ons shall be carried out in ac cordance with the provisions of 
DSTU 4659-1-2:2006 “Clinical Investigations  of Medical Products for Humans” (ISO 
14155-1-2; 2003, MOD).       47. The manufacturer or its authorised  person shall submit a report to the Ministry 
of Health in accordance with DSTU 4659-1-2:2006 “Clinical Investigations of Medical Products for Humans” (ISO 14155-1-2; 2003, MOD).       48. The provisions of Clauses 46-47 of  this Technical Regul ation shall not cover 
clinical investigati ons that use active medical products  which are implanted that, in 
accordance with the requirements of this Technical Regulation, are marked with the 
National Mark of Conformity if only during the investigations th e products are not 
used for purposes other than intended, according to the relevant procedure of conformity assessment.        The related provisions of DSTU  4659-1-2:2006 “Clinical Investigations of 
Medical Products for Humans” are in force for the mentioned clinical investigations.                                                                             Annex to the Technical Regulation  
DECLARATION 
of conformity 
 
(full name of the manufacturer , or its authorised agent, 
 
that are residents of Ukraine, or supplier; 
 
their locations and code according to EDPNOU (if registered)) 
 
represented by ________________________________________________________ 
(position, surname, first name, patr onymic name of the manufacturer, 
 
or its authorised agent, or supplier 
 
confirms that the active medical product which is implanted 
 
(full name of the medical product, type, brand, model) 
 that is being produced following__________________________________________                                                     (name and code of the technical documentation)  conforms to the Technical Regulation for active medical product which is implanted 
according to___________________________________________________________                             (title and code of normativ e documents (if present))  23
 
Technical documentation on the active medical product in compliance with the 
Technical regulation is available.  Certificate of the type insp ection (if present)   ________________________________ 
                                                           (number of the certificate of the type verification, 
 
its registration date, expiry date, name 
 
and location of the designated body) 
      The log sheet of trials of the active medica l product which is implanted, carried out by 
the designated body, or under its supervision (if required) 
 
(number of the log sheet, date of filling out, name 
 
and location of the designated body) 
 This Declaration is drawn up under full re sponsibility of the manufacturer, its 
authorised agent and supplier.    ______________                _________________                _______________        (title)                                (si gnature)                                 (printed name) 
        SEAL ______ Date    Document publications: _____________________________________________________________________-  Ofitsijnyj Visnyk Ukrajiny of 25.07.2008 - 2008,N 52, p.11, article 1737, code 
43666/2008 _____________________________________________________________________