0A4F4F9BD490A749D5437F821CF06DF1
Medical Devices Act (2016)
https://www.bda.bg/images/stories/documents/legal_acts/ZMI_en_20160308.pdf
http://leaux.net/URLS/ConvertAPI Text Files/20F2DAF60BA24617797D480DC9C7E885.en.txt
Examining the file media/Synopses/20F2DAF60BA24617797D480DC9C7E885.html:
This file was generated: 2020-07-14 08:05:47
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Illegal Activity
Searching for indicator crime:
(return to top)
p.(None): Act and the secondary legislative documents related to its application, shall be obliged not to disclose any
p.(None): information, obtained for and with regard to fulfillment of their obligations.
p.(None): (2) The provision of par. 1 shall not apply with regard to:
p.(None): 1. exchange of information between officials, between notified bodies and between officials and notified
p.(None): bodies;
p.(None): 2. disclosure of information which has as an objective to provide humans safety and health; 3. provision of information
p.(None): in case of prosecution proceedings.
p.(None): (3) Shall not be confidential the information:
p.(None): 1. about the registration of the persons, launching medical devices on the market pursuant to the provisions of Chapter
p.(None): two;
p.(None): 2. which is provided to the users by the manufacturer, by his/her authorized representative or by the wholesaler
p.(None): concerning the measures undertaken according to the provisions of Chapter seven;
p.(None): 3. is contained in the granted, modified, supplemented and withdrawn certificates and in the certificates,
p.(None): the validity of which is temporarily suspended.
p.(None):
p.(None):
p.(None): Chapter nine.
p.(None): ADMINISTRATIVE PUNITIVE PROVISIONS
p.(None):
p.(None): Art. 119. Whoever places on the market and/or puts into service medical devices, the
p.(None):
p.(None): conformity of which has not been assessed in accordance with this Act and the acts for
p.(None): its implementation, shall be imposed with a fine from 10 000 to 20 000 BGN.
p.(None):
p.(None):
p.(None): Art. 120. Whoever draws up or uses declaration of conformity with contents that does not meet the requirements set out
p.(None): in Art. 18, shall be imposed with a fine from 3000 to 8000 BGN, unless the act is a crime.
p.(None):
p.(None):
p.(None): Art. 121. Whoever places on the market and/or puts into service medical devices, whose CE marking violates the
p.(None): requirements under para 15, shall be imposed with a fine from 5000 to 1000 BGN.
p.(None):
p.(None):
p.(None): Art. 122. Whoever places on the market and/or puts into service medical devices with CE marking without
p.(None): having assessed their conformity with the essential requirements, set out by the ordinances as per Art. 18,
p.(None): shall be imposed with a fine from 10 000 to 20 000 BGN.
p.(None):
p.(None):
p.(None): Art. 123. Persons who present medical devices at exhibitions, trade fairs, demonstrations, promotions,
p.(None): scientific and technical conferences in violation of Art. 15, para 11 shall be punished by a fine amounting from 500 to
p.(None): 1000 BGN.
p.(None):
p.(None):
p.(None): Art. 124. Whoever places on the market and/or puts into service medical devices in violation of the provision of Art.
p.(None): 16, shall be punished by a fine amounting from 5000 to 10 000 BGN.
p.(None):
p.(None):
p.(None): Art. 125. Whoever places on the market and/or puts into service medical devices without instructions for
p.(None): use, except for the devices referred to in Art. 2, 1, item 3 falling in class II and class Iia, in case such may be
p.(None): utilized safely without instructions for use, shall be punished by a fine amounting from 3000 to 5000 BGN.
p.(None):
p.(None):
p.(None): Art. 126. Whoever places on the market and/or puts into service systems and/or sets of medical devices intended by the
p.(None): manufacturer for sterilization before use in violation of the requirements of this Act and the acts related to its
p.(None): implementation, shall be punished by a fine amounting from 10 000 to 15 000 BGN.
p.(None):
p.(None):
...
p.(None):
p.(None): Art. 136. (amend. - SG 60/11, in force from 05.08.2011; amend. – SG 54/12) A wholesale trader who
p.(None): breaches the regulation of Art. 80a, para 1 shall be punished by a propriety sanction amounting to 1000
p.(None): BGN.
p.(None):
p.(None):
p.(None): Art. 137. Whoever carries out retail trade in medical devices without CE marking affixed, or in medical devices whose
p.(None): shelf life has expired, shall be punished by a fine amounting to 10 000 BGN.
p.(None):
p.(None): Art. 138. (amend. – SG 54/12) Whoever carries out retail trade in medical devices outside health
p.(None): establishments under Art. 21, Para 2, Item 4 and Para 3 of the Health Act and/or outside the sites under Art. 83, para
p.(None): 1, item 4 - 7, shall be imposed a fine or a property sanction amounting to BGN 10 000.
p.(None):
p.(None):
p.(None): Art. 138a. (new – SG 54/12) A trader in medical devices violating the requirements of Art. 83b shall be imposed a
p.(None): property sanction amounting to BGN 1000.
p.(None):
p.(None):
p.(None): Art. 139. (amend. – SG 110/08) Whoever places on the market and/or puts into service medical devices on the territory
p.(None): of the Republic of Bulgaria without being registered within the prescribed term, shall be punished by a fine amounting
p.(None): to 5000 BGN.
p.(None):
p.(None):
p.(None): Art. 140. (amend. – SG 110/08, in force from 21.03.2010) Whoever violates the requirements of Art. 27, para 3, Art. 28,
p.(None): para 7, Art. 29, para 2 and Art. 30 shall be punished by a fine amounting to 3000 BGN.
p.(None):
p.(None):
p.(None): Art. 141. (1) Whoever breaches the requirements for carrying out clinical trials, if this does not constitute a crime,
p.(None): shall be punished by a fine amounting from 5000 to 10 000 BGN, and in the event of repeated violation - a fine
p.(None): amounting from 10 000 to 20 000 BGN.
p.(None): (2) A medical expert who has committed violations under para 1 may be punished with deprivation of right
p.(None): to exercise the profession for a period from six months to two years.
p.(None): (3) The punishment under para 2 shall be imposed by the Minister of Health upon proposal by the executive director of
p.(None): BDA.
p.(None):
p.(None):
p.(None): Art. 142. A notified body, which fails to meet the requirement as per Art. 68, para 1, shall be punished by a sanction
p.(None): amounting from 2000 to 5000 BGN.
p.(None):
p.(None):
p.(None): Art. 143. A notified body, which fails to meet the requirement as per Art. 70, para 1, shall be punished by a propriety
p.(None): sanction amounting to a maximum of 5000 BGN.
p.(None):
p.(None):
p.(None): Art. 143a. (new – SG 110/08; amend. - SG 38/15, in force from 26.05.2015)A notified body, which fails to meet the
p.(None): requirement as per Art. 76, para 3 and 4, shall be punished by a propriety sanction amounting to a
p.(None): maximum of 5000 BGN.
p.(None):
p.(None):
p.(None): Art. 144. Whoever impedes the persons as per Art. 86, para 2 to fulfill their official duties according
p.(None): to the provisions of Chapter VI, shall be punished by a fine amounting from 6000 to 10 000 BGN.
p.(None):
p.(None):
p.(None): Art. 145. A manufacturer of medical devices who violates the provision of Art. 103, para 1
p.(None):
p.(None): shall be punished by a propriety sanction amounting from 5000 to 10 000 BGN.
p.(None):
p.(None):
p.(None): Art. 146. A manufacturer of medical devices who violates the provision of Art. 107, shall be punished by a propriety
p.(None): sanction amounting from 10 000 to 20 000 BGN
p.(None):
...
Political / political affiliation
Searching for indicator party:
(return to top)
p.(None): 2. (new - SG 38/15, in force from 26.05.2015) issue conformity assessment authorizations for medical devices under
p.(None): Chapter Four;
p.(None): 3. (prev. text of item 2 - SG 38/15, in force from 26.05.2015) issue authorizations for carrying out clinical
p.(None): investigations of medicinal products;
p.(None): 4. (amend. – SG 54/12; prev. text of item 3 - SG 38/15, in force from 26.05.2015) issue authorizations
p.(None): for wholesale trade in medical devices;
p.(None): 5. (prev. text of item 4 - SG 38/15, in force from 26.05.2015) supervise the medical devices that have been placed on
p.(None): the market and/or put into service;
p.(None): 6. (amend. – SG 54/12; prev. text of item 5 - SG 38/15, in force from 26.05.2015) exercise control
p.(None): over the storage, trade, clinical investigations and safety of medical devices;
p.(None): 7. (prev. text of item 6 - SG 38/15, in force from 26.05.2015) keep a system for registration and analysis of reports
p.(None): on incidents with medical devices and undertake the necessary measures;
p.(None): 8. (prev. text of item 7 - SG 38/15, in force from 26.05.2015) have its representatives in the Central Ethics
p.(None): Committee, established under the Medicinal Products in Human Medicine Act;
p.(None): 9. (prev. text of item 8 - SG 38/15, in force from 26.05.2015) provide information concerning medical devices that have
p.(None): been placed on the market and/or put into service to the European Database;
p.(None): 10. (prev. text of item 9 - SG 38/15, in force from 26.05.2015) take part in actions in the medical
p.(None): devices field related to the activity of international authorities, organizations and agreements to which the
p.(None): Republic of Bulgaria is a party, together with the regulatory and control bodies of other countries and
p.(None): the organizations carrying out activity in the sphere of medical devices regulation;
p.(None): 11. (amend. – SG 110/08; prev. text of item 10, suppl. - SG 38/15, in force from 26.05.2015) create and keep the
p.(None): registers under Art. 31, par. 2, Art. 58, par. 1, Art. 67, para 1 and Art. 81;
p.(None): 12. (prev. text of item 11 - SG 38/15, in force from 26.05.2015) carry out other activities specified
p.(None): in this Act.
p.(None):
p.(None):
p.(None): Art. 6a (new – SG 110/08, in force from 21.03.2010) The Bulgarian Drug Agency shall draw
p.(None):
p.(None): up a justified request to the European Commission for undertaking necessary measures, whenever it
p.(None): considers, that:
p.(None): 1. the application of the classification rules of Art. 2, par. 3 requires taking a decision for
p.(None): classification of a particular medical device or category of devices of Art. 2, par. 1, item 3;
p.(None): 2. a particular medical device or a group of devices of Art. 2, par. 1, item 3, regardless the
p.(None): classification rules of Art. 2, par. 3 may be classified under a different class of devices;
p.(None): 3. the conformity of a particular medical device or of a group of devices of Art. 2, par. 1, item 2 or 3 must be
p.(None): assessed by applying only one single procedure provided in the ordinances of Art. 18;
p.(None): 4. taking a decision is necessary, whether a particular product or a group of products falls into the scope of
p.(None): application of this Act.
p.(None):
p.(None):
p.(None): Art. 7. (1) For the purpose of registration and issue of registration certificates, issue of
...
p.(None): procedures, the Good Clinical Practice an the applicable control requirements.
p.(None): 26. "A person independent from the assignor" is a natural person acquainted with the characteristics and
p.(None): the operation of the medical device – subject to a clinical investigation, and with the methodology of conducting such,
p.(None): and who is financially independent from the assignor.
p.(None): 27. "Clinical trial plan" is a document providing information on the purposes, design, methodology,
p.(None): statistical methods and organization of a clinical investigation.
p.(None): 28. "Intended purpose" means the use for which a medical device has been designated according to the
p.(None): data provided by the manufacturer on its label, the instructions for use and/or the advertisement notices.
p.(None): 29. "Accessory" means an Art. which, whilst not being a medical device, is intended specifically by its
p.(None): manufacturer to be used together with a device to enable that device to be used in accordance with its intended
p.(None): purpose.
p.(None): For the purposes of this definition, invasive sampling devices or those which are directly applied to
p.(None): the human body for the purpose of obtaining a specimen within the meaning of Directive 93/42/EEC shall not
p.(None): be considered to be accessories to in vitro diagnostic medical devices;
p.(None): 30. "Manufacturer" means the natural or legal person who:
p.(None): a) is responsible for the design, manufacture, packaging and labelling of a device before it is
p.(None):
p.(None): placed on the market under his own name, regardless of whether these operations are carried out by that person himself
p.(None): or on his behalf by a third party;
p.(None): b) (amend. – SG 11/08) assembles, packages, processes, fully refurbishes and/or labels one or more ready-made products
p.(None): and/or assigns to them their intended purpose as devices with a view to their being placed on the market under his own
p.(None): name.
p.(None): Natural or legal persons who assembles or adapts devices already on the market to their intended purpose
p.(None): for an individual patient shall not be considered manufacturers within the meaning of this Act.
p.(None): 31. "Putting into service" means the stage at which a device has been made available to the final user as
p.(None): being ready for use in a Member State or a state from the European Economic Area for the first time for its intended
p.(None): purpose. of An active implantable medical device shall be considered put into service when made available to a
p.(None): qualified expert for implanting.
p.(None): 32. "Placing on the market" means the first making available in return for payment or free of charge of a device, other
p.(None): than a medical device for clinical trial and a device intended for performance evaluation, with a view to distribution
p.(None): and/or use on the territory of the European Union or the European Economic Area, regardless of whether it is new or
p.(None): fully refurbished.
p.(None): 33. "Serious health damage" means:
p.(None): 1. life-threatening condition, illness or harm;
p.(None): 2. lasting harm to the life functions or to a human organ or tissue;
p.(None): 3. a condition which requires medical or surgical intervention in order to prevent the damages under item 2;
p.(None): 34. "Human specimen receptacles" are those devices, whether vacuum-type or not, specifically intended by their
p.(None): manufacturers for the primary containment and preservation of specimens derived from the human body for the
p.(None): purpose of in vitro diagnostic examination.
p.(None): 35. "Essential amendment in the clinical trial plan" means any amendment in the plan and/or the information contained
p.(None): in the documentation that goes along with it, which affects:
p.(None): a) the safety or the physical and mental integrity of the persons involved; b) the scientific value of the
p.(None): investigation;
p.(None): c) the conducting or organization of the trial.
p.(None): 35a. (new - SG 38/15, in force from 26.05.2015) "Third country" shall mean any which is not an EU member or not a
p.(None): state - party to the Agreement on the European Economic Area or Swiss Confederation.
p.(None): 36. (amend. – SG 54/12) "Retail trade" are all activities related to acquisition, storage and sale of medical devices
p.(None): to the population.
p.(None): 37. (amend. – SG 54/12) "Wholesale trade" are all activities related to acquisition, storage, supply,
p.(None): import or export of medical devices intended for sale, except the cases of providing medical devices
p.(None): directly to the population.
p.(None): 38. (amend. – SG 110/08) "Authorised representative" means any natural or legal person established on the
p.(None): territory of a Member State or a state from the European Economic Area who, explicitly authorized by
p.(None): the manufacturer to act on his/her behalf and for his/her account before regulatory bodies of the Member
p.(None): States or the regulatory bodies of the states of the European Economic Area for the fulfillment of manufacturer's
p.(None): obligations under this Act.
p.(None):
p.(None):
p.(None): § 2. (amend. – SG 110/08, in force from 21.03.2010) This Act introduces the requirements of Directive 90/385/EEC of the
p.(None): Council of 20 July 1990 on the approximation of the legislation of Member States relating to active implantable
p.(None): medical devices, last amended with Directive 2007/47/EC of the European Parliament and of the Council of 5
p.(None): September 2007 amending the Directive 90/385/EEC of the Council on the approximation of the legislation of
p.(None): Member States relating to active implantable
p.(None):
p.(None): medical devices, of Directive 93/42/EEC of the Council concerning the medical devices and of Directive 98/8/EC
p.(None): concerning the placing on the market of biocidal products (OJ, L 247/21 of 21 September 2007), of
...
Health / Drug Usage
Searching for indicator drug:
(return to top)
p.(None): stored, distributed, installed, implanted and maintained according to the instructions manufacturers;
p.(None): 2. ensuring the implementation of Commission Regulation (EU) № 920/2013 of 24 September 2013 on the designation and the
p.(None): supervision of notified bodies under the Council Directive 90/385/EEC on active implantable medical devices and the
p.(None): Council Directive 93/42/EEC on medical devices_ (OJ, L 253/8 of 25 September 2013), hereinafter referred to as
p.(None): "Implementing Regulation (EU) № 920/2013.
p.(None):
p.(None):
p.(None): Art. 2. (1) Depending on the operation intended by the manufacturer, medical devices shall be categorised as follows:
p.(None): 1. in-vitro diagnostic medical devices; 2. active implantable medical devices;
p.(None): 3. medical devices other than the ones specified in items 1 and 2.
p.(None): (2) Medical devices under para.1, item 1 are classified in List A, List B and self-testing devices, as well as in other
p.(None): groups determined in the ordinances as per Art.18, depending on the potential risk related to them.
p.(None): (3) Depending on the potential risk related to them the medical devices under para.1, item 3 are
p.(None):
p.(None): grouped into class I, IIa, IIb and III according to classification rules set out in the ordinances
p.(None): under Art.18.
p.(None): (4) (amend. – SG 110/08, in force from 21.03.2010) In case the manufacturer and the notified authority determined
p.(None): pursuant to Chapter IV have different opinions regarding the implementation of the classification rules under
p.(None): para.3, the Bulgarian Drug Agency (BDA) shall take a decision. When it deems it appropriate and when
p.(None): the conditions under Art. 6a, item 1 or 2 are present, the BDA shall prepare a justified request to the
p.(None): European Commission for undertaking relevant measures.
p.(None): (5) (amend. – SG 110/08, in force from 21.03.2010) In case this is explicitly required, the
p.(None): classification rules under para.3 to be brought in compliance with new technologies development and/or with
p.(None): information received according to Chapter VII, BDA shall work out a reasoned request for undertaking the
p.(None): necessary measures which is to be submitted to the European Commission.
p.(None):
p.(None):
p.(None): Art. 3. The requirements for medical devices provided for in the present Act also apply to: 1. accessories to the
p.(None): devices;
p.(None): 2. devices including as an integral part a substance which, if used separately, may be considered to be a medicinal
p.(None): product within the meaning of the Medicinal Products in Human Medicine Act and which has an auxiliary effect on the
p.(None): organism with regards to the principal intended action of the device; 3. devices including as an integral part a
p.(None): substance obtained from human blood or plasma
p.(None): which, if used individually, may be considered a component of a medicinal product or a medicinal product
p.(None): under the Medicinal Products in Human Medicine Act and which has an auxiliary effect on the organism with regards to
p.(None): the principal intended action of the device;
p.(None): 4. devices with the use of which medicinal products are being applied;
...
p.(None): 6. (amend. – SG 54/12; prev. text of item 5 - SG 38/15, in force from 26.05.2015) exercise control
p.(None): over the storage, trade, clinical investigations and safety of medical devices;
p.(None): 7. (prev. text of item 6 - SG 38/15, in force from 26.05.2015) keep a system for registration and analysis of reports
p.(None): on incidents with medical devices and undertake the necessary measures;
p.(None): 8. (prev. text of item 7 - SG 38/15, in force from 26.05.2015) have its representatives in the Central Ethics
p.(None): Committee, established under the Medicinal Products in Human Medicine Act;
p.(None): 9. (prev. text of item 8 - SG 38/15, in force from 26.05.2015) provide information concerning medical devices that have
p.(None): been placed on the market and/or put into service to the European Database;
p.(None): 10. (prev. text of item 9 - SG 38/15, in force from 26.05.2015) take part in actions in the medical
p.(None): devices field related to the activity of international authorities, organizations and agreements to which the
p.(None): Republic of Bulgaria is a party, together with the regulatory and control bodies of other countries and
p.(None): the organizations carrying out activity in the sphere of medical devices regulation;
p.(None): 11. (amend. – SG 110/08; prev. text of item 10, suppl. - SG 38/15, in force from 26.05.2015) create and keep the
p.(None): registers under Art. 31, par. 2, Art. 58, par. 1, Art. 67, para 1 and Art. 81;
p.(None): 12. (prev. text of item 11 - SG 38/15, in force from 26.05.2015) carry out other activities specified
p.(None): in this Act.
p.(None):
p.(None):
p.(None): Art. 6a (new – SG 110/08, in force from 21.03.2010) The Bulgarian Drug Agency shall draw
p.(None):
p.(None): up a justified request to the European Commission for undertaking necessary measures, whenever it
p.(None): considers, that:
p.(None): 1. the application of the classification rules of Art. 2, par. 3 requires taking a decision for
p.(None): classification of a particular medical device or category of devices of Art. 2, par. 1, item 3;
p.(None): 2. a particular medical device or a group of devices of Art. 2, par. 1, item 3, regardless the
p.(None): classification rules of Art. 2, par. 3 may be classified under a different class of devices;
p.(None): 3. the conformity of a particular medical device or of a group of devices of Art. 2, par. 1, item 2 or 3 must be
p.(None): assessed by applying only one single procedure provided in the ordinances of Art. 18;
p.(None): 4. taking a decision is necessary, whether a particular product or a group of products falls into the scope of
p.(None): application of this Act.
p.(None):
p.(None):
p.(None): Art. 7. (1) For the purpose of registration and issue of registration certificates, issue of
p.(None): authorization and certificates according to this Act, as well as for entering amendments therein, shall be paid fees
p.(None): the amount of which is specified in a tariff, approved by the Council of Ministers.
p.(None): (2) (amend. - SG 38/15, in force from 26.05.2015) The amounts of fees under para.1 and of fines and property
p.(None): sanctions enforced on natural and legal persons according to this Act shall be deposited as budget revenue
p.(None): of BDA.
p.(None):
p.(None):
p.(None): Section II.
p.(None): Placing on the market and/or putting into service of medical devices
p.(None):
p.(None): Art. 8. (1) Medical devices shall be released on the market and/or put into service provided that they meet the
p.(None): requirements of this Act and the acts relating to its implementation.
p.(None): (2) Medical devices, except for custom-made ones, shall be placed on the market and/or put into service if they bear
p.(None): the CE marking under Art.15 certifying that the compliance of the devices with the essential requirements has been
p.(None): assessed by means of the applicable conformity assessment procedures.
p.(None):
p.(None):
p.(None): Art. 9. (1) The Executive Director of BDA shall issue an order for temporary suspension or prohibition of
p.(None): placing on the market and/or putting into service and for withdrawal from the market of medical devices with CE marking
p.(None): as per Art.15, as well as of custom-made devices, which can threaten the health and safety of patients, medical
p.(None): experts or third persons, when they are correctly installed, maintained and used.
p.(None): (2) The Bulgarian Drug Agency shall notify immediately the European Commission of the order under para.1
p.(None): and the measures taken, stating the reasons for the medical devices non-conformity with the requirements of this Act
p.(None): and the acts for its implementation, due to:
p.(None): 1. failure to meet the essential requirements referred to in the ordinances as per Art.18; 2. incorrect application of
p.(None): the standards referred to in Art.13, para.1;
p.(None): 3. shortcomings in standards under Art.13, para.1.
p.(None):
p.(None):
p.(None): Art. 10. (1) The manufacturer is the person in charge of placing on the market and/or putting into service of medical
p.(None): devices.
p.(None): (2) (amend. – SG 110/08) In case the manufacturer is not established on the territory of a
p.(None): Member State or a state from the European Economic Area, they shall authorize in writing their
p.(None): representative, hereafter referred to as "authorized representative". For a medical device or a device of
p.(None):
p.(None): the same model, launched on the Community market, the manufacturer shall authorize only one person.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): shall be
p.(None): Art. 11. (1) (suppl. – SG, 84/2012, in force from 02.01.2013) Manufacturers of medical devices obliged to design,
p.(None): develop, produce, package and label them according to the essential
p.(None): requirements set out in the ordinances as per Art.18 and this act and/or of Chapter Five “a” and of the ordinance under
p.(None): Art. 21e, Para. 1 of the Act on Protection of Dangerous Impact of Chemical Substances and Mixtures, and to ensure
p.(None): assessment of their conformity by means of applicable procedures.
...
p.(None): Policy, from the budget of the medical establishments referred to in Art. 5 of the Medical
p.(None): Establishments Act, as well as by funds of the medical establishments with state and/or municipal share under
p.(None): Art. 9 and 10 of theMedical Establishments Act.
p.(None): (2) The list referred to in Para 1 shall contain:
p.(None): 1. general identification data and characteristics of the medical establishment; 2. certification and registration
p.(None): status of the medical device;
p.(None): 3. trade information, including retail price of the medical device, as well as about the
p.(None): manufacturer/authorised representative or the trader of the medical device;
p.(None): 4. value as referred to in Art. 30b, Para 1.
p.(None): (3) The conditions and order for entry into the list referred to in Para 1 and for its maintenance shall be determined
p.(None): in an ordinance of the Council of Ministers adopted upon proposal of the Minister of the Health and the Minister of
p.(None): Labour and Social Policy.
p.(None): (4) The medical devices outside the list referred to in Para 1 shall not be paid from the funds referred to in Para 1.
p.(None):
p.(None):
p.(None): Art. 30b. (new - SG 39/11, in force from 01.01.2012) (1) Every year the state shall determine the value up to which
p.(None): shall be paid the medical devices referred to in the list under Art. 30a, Para 1.
p.(None): (2) The conditions and order for determining the value of the medical devices under Para 1 shall be
p.(None): determined in the ordinance referred to in Art. 30a, Para 3.
p.(None):
p.(None): Art. 31. (1) (revoked – SG 110/08, in force from 21.03.2010).
p.(None): (2) (amend. – SG 110/08, in force from 21.03.2010) The Bulgarian Drug Agency shall maintain a register containing:
p.(None): 1. number and registration date;
p.(None): 2. name, type and class of the medical device;
p.(None): 3. name and business address of the applicant under Art. 27, par. 1, Art. 28, par. 1 and 3 and Art. 29, par. 1;
p.(None): 4. date of deletion of the medical device from the register and the reason for this; 5. remarks on documented
p.(None): circumstances.
p.(None): (3) (amend. – SG 110/08, in force from 21.03.2010) The Bulgarian Drug Agency presents registration data
p.(None): for the devices under Art. 27, par. 1, Art. 28, par. 1 and 3 and under Art. 29, par. 1 upon request by the regulatory
p.(None): authorities of other Member States or regulating authorities or the states of the European Economic Area and by the
p.(None): European Commission.
p.(None):
p.(None):
p.(None): Chapter three.
p.(None): CLINICAL INVESTIGATION OF MEDICAL DEVICES
p.(None):
p.(None): Section I. General Provisions
p.(None):
p.(None): Art. 32. (amend. – SG 110/08, in force from 21.03.2010) Clinical testing with medical devices under Art. 2, par. 1,
p.(None): item 2 and 3 shall be carried out in order to:
p.(None): 1. confirm that under normal conditions of use the device performs one or more of its functions, determined by the
p.(None): manufacturer;
p.(None): 2. identify adverse side effects under normal conditions of use of the device;
p.(None): 3. assess to what extend the indentified adverse side effects are within the acceptable risk assessed in
p.(None): comparison to the benefit of the intended purpose of use of the device.
p.(None):
p.(None):
p.(None): Art. 32a (new – SG 110/08, in force from 21.03.2010) The assessment of clinical testing data shall be carried out under
p.(None): the conditions, set out in the ordinance under Art. 48, par. 2.
p.(None):
p.(None):
p.(None): Art. 33. A clinical investigation shall be carried out in a medical establishment in accordance with the Medical
p.(None): Establishments Act.
p.(None):
p.(None):
p.(None): Art. 34. (1) Clinical investigations of devices referred to in Art. 32 shall be carried out according
p.(None): to the main principles of the protection of human rights, safety and human dignity of the clinical trial
...
p.(None):
p.(None):
p.(None): Art. 44. (1) The assignor and principal or coordinating investigator shall conclude insurance agreements,
p.(None): covering their liability for material and non-material damages to the trial subjects.
p.(None): (2) The assignor shall be responsible in case of damage to health or death caused during or in the occasion of the
p.(None): conduct of the clinical investigation where the said trial has been carried out in compliance with the
p.(None): requirements and procedures of the plan as approved by the ethics committee.
p.(None): (3) The principal or coordinating investigator shall be responsible in case of health damage or death caused during or
p.(None): in the occasion of clinical trial where the said trial has not been carried out in compliance with the requirements and
p.(None): procedures of the plan as approved by the ethics committee.
p.(None):
p.(None):
p.(None): Section II.
p.(None): Clinical Trial Authorizations
p.(None):
p.(None): Art. 45. (1) Clinical trials of medical devices referred to in Art. 2, para 1, item 3 from class III, of implantable
p.(None): medical devices and invasive medical devices for long-term use as per Art. 2, para 1, item 3 from class IIа or IIb
p.(None): and of devices under Art. 2, para 1, item 2, which take place on the territory of the Republic of Bulgaria can commence
p.(None): upon receiving a positive stand of the Multi-centre Research Ethics Committee or the ethics committee at the respective
p.(None): medical establishment, and an authorization by the Executive Director of the Bulgarian Drug Agency (BDA).
p.(None): (2) Clinical trials of medical devices other than the ones referred to in para 1 which take place on the territory of
p.(None): the Republic of Bulgaria can commence upon notification to the Executive Director of BDA, if the relevant ethics
p.(None): committee under para 1 has given a favourable opinion.
p.(None): (3) The provisions of para 1 and para 2 shall also apply to medical devices with applied "CЕ" marking in case the
p.(None): clinical trials are conducted with the purpose of change in their intended purpose.
p.(None):
p.(None):
p.(None): Art. 46. The assignor or the principal/coordinating investigator can submit an application form for notification or
p.(None): authorization for conducting a clinical trial to the relevant ethics committee and to BDA simultaneously or
p.(None): consequently.
p.(None):
p.(None):
p.(None): Art. 47. (1) In the case of multi-centre clinical trial on the territory of the Republic of Bulgaria persons as per
p.(None): Art. 46 shall submit an application form to the Multi-centre Research Ethics Committee.
p.(None): (2) In the case of one-site clinical trial on the territory of the Republic of Bulgaria persons
p.(None): referred to in Art. 46 shall submit an application form to the Multi-centre Research Ethics Committee or
p.(None):
p.(None): to the ethics committee at the respective medical establishment.
p.(None):
p.(None):
...
p.(None): 46;
p.(None): 10. a declaration, that the medical device conforms with the applicable essential requirements, except those, which
p.(None): are subject to clinical testing, and that all preventive measures, required for protection of the health and
p.(None): safety of the participants in the testing and of the research team have been
p.(None):
p.(None): provided;
p.(None): 11. an insurance contract, covering the researcher’s and the applicant’s responsibility for caused proprietary and
p.(None): non-proprietary damages to the participants in the testing during or with reference to the implementation of the
p.(None): clinical testing;
p.(None): 12. a draft contract between the applicant and the medical establishment;
p.(None): 13. a document certifying paid fee to the amount determined in the tariff as per Art.7, para 1; (2) (revoked – SG
p.(None): 110/08, in force from 21.03.2010).
p.(None): (3) (amend. – SG 110/08, in force from 21.03.2010) In case of application forms as per Art. 46 submitted
p.(None): simultaneously, the applicant can present his/her opinion under para 1, item 9 after its obtaining, but
p.(None): not later than the term fixed under Art. 51, para 1.
p.(None): (4) (amend. – SG 110/08, in force from 21.03.2010) The applicant shall declare that the information,
p.(None): provided in the documents submitted to BDA and to the ethics commission is identical.
p.(None): (5) (new – SG 110/08, in force from 21.03.2010) The content of the documentation of par. 1 shall be determined by the
p.(None): ordinance of Art. 48, par. 2.
p.(None):
p.(None):
p.(None): Art. 51. (1) The Bulgarian Drug Agency assesses the provided documents as per Art. 50 within 60-days from the date of
p.(None): their submission.
p.(None): (2) (amend. – SG 110/08, in force from 21.03.2010) The Bulgarian Drug Agency may request additional information about
p.(None): the documents referred to in Art. 50, para 1.
p.(None): (3) In the cases referred to in para 2, the 60-day term shall stop running until the submission of the requested
p.(None): documentation.
p.(None): (4) Within the period under para 1, the Executive Director of BDA shall notify in writing the applicant that:
p.(None): 1. they issue an authorization to conduct the clinical trial or,
p.(None): 2. the trial may not be carried out, stating the reasons for refusal.
p.(None): (5) In the cases referred to in para 4, item 2, within 30 days from the date of notification, the applicant can submit
p.(None): to BDA an application amended in accordance with the reasons stated for refusal to conduct the clinical trial.
p.(None): (6) Within 30 days from the date of submission of the amended application under para 5, BDA shall inform the applicant
p.(None): in writing that:
p.(None): 1. they approve the conduct of the clinical trial, or
p.(None): 2. the trial cannot be carried out, stating the reasons for refusal.
p.(None): (7) A copy of the clinical trial authorization shall be sent to the medical establishment pointed out in the
p.(None): application under Art. 50, para 1.
p.(None): (8) In case BDA has not pronounced in the term fixed as per para 1, the applicant can start the investigation
p.(None): immediately.
p.(None):
p.(None):
p.(None): Art. 52. (1) The Executive director of BDA shall pass a well-grounded refusal to conduct a clinical
p.(None): trial on the territory of the Republic of Bulgaria in those cases where:
p.(None): 1. there has not been provided enough evidence for the anticipated scientific and medical benefits from
p.(None): the use of the medical device in question;
p.(None): 2. there has not been provided enough for the safety of the trial subjects and/or the investigation
p.(None):
p.(None): team;
p.(None):
p.(None): 3. the provided information regarding clinical trial safety assessment is insufficient;
p.(None): 4. the operation of the device does not comply with its intended use defined by the
p.(None): manufacturer.
p.(None): (2) Refusals under para 1 shall be subject to appeal under the terms of the Administrative
p.(None):
p.(None): Procedure Code.
p.(None): (3) (amend. – SG 110/08, in force from 21.03.2010) The Bulgarian Drug Agency shall notify the regulatory authorities
p.(None): of the other member States, the regulatory authorities of the states of the European Economic Area and
p.(None): the European Commission of the refusal under para 1 and presents its reasons therefore.
p.(None):
p.(None):
p.(None): Art. 53. (1) Applicant can make amendments in the investigation plan, other than essential ones, at any
p.(None): time.
p.(None): (2) In cases referred to in para 1 the applicant shall keep the documentation relating to the
p.(None): amendments and shall provide it to the BDA and the ethics committee upon request.
p.(None):
p.(None):
p.(None): Art. 54. (1) The assignor can implement planned essential amendments in the clinical trial plan. (2) In the cases
p.(None): referred to in para 1, the applicant shall submit an application form along with
p.(None): the documents regarding the amendments, to the respective ethics committee and to BDA.
p.(None): (3) The ethics committee passes a stand within 15 days from receiving the application under para 2 and presents it to
p.(None): the assignor and BDA.
p.(None): (4) Within 15 days from the date of receiving the stand by the respective ethics committee, the Executive Director of
p.(None): BDA shall:
p.(None): 1. issue an amendment to the clinical trial authorization, approving the change in the trial plan,
p.(None): or
p.(None): 2. pass a well-grounded refusal for the substantial amendment referred to in para 1. (5) The refusal under para 4, item
p.(None): 2 shall not be subject to appeal.
p.(None): (6) If within the term under para 4 the applicant does not receive a refusal by BDA, he/she can
...
p.(None): non-viable products, produced from animal tissues have been used;
p.(None): 7. the results of the engineering calculations and the accomplished inspections and technical
p.(None): tests.
p.(None): (2) (amend. – SG 110/08, in force from 21.03.2010) The assignor of the clinical test is obliged
p.(None): to keep the documentation of par. 1 for a period of 15 years after the accomplishment of the clinical test
p.(None): – for the devices under Art. 2, para 1, item 2, and for implantable devices under Art. 2, para 1, item 3, and 5 years
p.(None): for the devices of Art. 2, par. 1, item 1.
p.(None): (3) (amend. – SG 110/08, in force from 21.03.2010) The manufacturer is obliged to ensure a production process whereby
p.(None): the medical devices intended for clinical trials are produced in accordance with the documentation of par. 1.
p.(None):
p.(None):
p.(None): Art. 57. (1) Within 90 days from completion of the clinical trial, the assignor presents to BDA and the respective
p.(None): ethics committee a final report containing a description of methodology and organization, critical assessment
p.(None): and statistical analysis of received data.
p.(None): (2) The report under para 1 shall be signed by the assignor and by all investigators. If one of the investigators
p.(None): refuses to sign it, he/she shall enclose his/her reasons in writing.
p.(None): (3) The report under para 1 shall summarize data received from all medical institutions and from all
p.(None): subjects in the trial.
p.(None): (4) Personal data of the trial subjects which are included in the report under para 1 shall be
p.(None): coded.
p.(None):
p.(None):
p.(None): Art. 58. (1) Bulgarian Drug Agency keeps a register of the issued and withdrawn clinical trial authorizations.
p.(None): (2) Bulgarian Drug Agency shall organize and establish a system for registration, analysis and summary of all incidents
p.(None): related to medical devices that have occurred in the course of clinical trials.
p.(None): (3) The medical devices pharmacovigilance procedure in the course of the clinical trial is provided in the
p.(None): as per under Art. 48, para 2.
p.(None):
p.(None): Art. 59. (1) The Executive Director of BDA can temporary suspend the trial being carried out or terminate it by an
p.(None): order, provided that:
p.(None): 1. the trial is conducted under conditions other than the ones stated in the authorization; 2. there is information
p.(None): raising doubts about violating the scientific validity of the trial; 3. there is a risk for the safety of the subjects.
p.(None): (2) Prior to undertaking any actions under para 1, BDA shall notify of their intentions:
p.(None): 1. the assignor and coordinating investigator, responsible for carrying out the trial at all sites,
p.(None): or,
p.(None): 2. the assignor and principal investigator, who is in charge of the relevant medical institution
p.(None): where the trial shall be terminated.
p.(None): (3) Within 7 days after notification under para 2 the assignor and the principal and coordinating investigator can
p.(None): present written explanations to BDA.
p.(None): (4) Para 2 shall not apply if there is imminent risk for the health and safety of the trial subjects. (5) The order
p.(None): under para 1 can be subject to appeal under the terms of the Administrative
p.(None): Procedure Code, provided that the appeal does not suspend its enforcement.
p.(None): (6) The principal or coordinating investigator notifies the clinical trial subjects of the order under
p.(None): para 1.
p.(None):
p.(None):
p.(None): Art. 60. (amend. – SG 110/08) (1) In case of termination of clinical testing the Executive Director of
p.(None): BDA shall notify immediately the regulatory authorities of the Member States of the regulatory bodies of
p.(None): the states of the European Economic Area and the European Commission of the order referred to in Art. 59, par. 1 and
p.(None): shall present justifications thereof.
p.(None): (2) In case of temporary suspension of the clinical testing the Executive Director of BDA shall notify immediately
p.(None): the regulatory authorities of the affected Member States or of the states of the European Economic Area,
p.(None): participating in the testing, of the ordinance referred to in Art. 59, par. 1 and shall present justifications thereof.
p.(None):
p.(None):
p.(None): Chapter four.
p.(None): NOTIFIED BODIES
p.(None):
p.(None): Art. 61. (amend. - SG 38/15, in force from 26.05.2015)
p.(None): (1) A conformity assessment authorization for medical devices, including clinical data assessment,
p.(None): shall be granted by the Executive Director of BDA to a natural or legal person, registered under the Commerce Act.
p.(None): (2) The Bulgarian Drug Agency shall be a designating authority for the purposes of Art. 1 letter "e" of Implementing
p.(None): Regulation (EU) № 920/2013.
p.(None): (3) A person applying for conformity assessment authorization of medical devices shall submit to BDA an application
p.(None): form on electronic media in accordance with Annex II of Implementing Regulation (EU) № 920/2013, stating the
p.(None): products and procedures applied for, areas of competence and the subdivisions of these areas - using the codes
p.(None): of the European Commission information system NANDO (New Approach Notified and Designated Organisations)
p.(None): and the annexes to the application referred to in Annex II of Implementing Regulation (EU) № 920/2013.
p.(None): (4) The applicant shall pay a fee for conformity assessment authorization of medical devices in the amount specified in
p.(None): the tariff under Art. 7, para. 1.
p.(None):
p.(None): Art. 62. (amend. - SG 38/15, in force from 26.05.2015) (1) The evaluation of a person applying for conformity
p.(None): assessment authorization of medical devices shall be carried out by an expert commission assigned by an order of the
p.(None): Executive Director of BDA. If necessary, in the commission may also be involved external experts who have knowledge and
p.(None): practical experience in the relevant medical devices.
p.(None): (2) Where a person applying for conformity assessment authorization for medical devices has stated medical devices
p.(None): under Art. 2 para. 1, item 1 in the application under Art. 61, para. 3, BDA shall perform assessment pursuant to Art.
p.(None): 62a.
p.(None): (3) Where a person applying for conformity assessment authorization for medical devices has stated medical devices
p.(None): under Art. 2 para. 1, item 2 or 3 in the application under Art. 61, para. 3, BDA shall perform the assessment
p.(None): pursuant to Art. 62a of this Act and Implementing Regulation (EU) № 920/2013.
p.(None): (4) The Bulgarian Drug Agency shall apply the assessment criteria under para 2 pr 3 for the respective person according
p.(None): to Annex I of Implementing Regulation (EU) № 920/2013.
p.(None): Art. 62a. (new – SG 38/15, in force from 26.05.2015) (1) The submitted documentation shall reviewed by the expert
p.(None): commission under Art. 62, para 1, or, where applicable, by a committee of representatives of the
p.(None): governing bodies of another two Member States and a representative of the European Commission.
p.(None): (2) Where any omissions or inconsistencies with the requirements of documentation are established, the
p.(None): Executive Director of BDA shall notify the applicant in writing and set a two-month
p.(None): deadline for their removal. The term under Art. 63 para. 1 or 2 shall be suspended until the said
p.(None): omissions or inconsistencies are removed.
p.(None): (3) Where the applicant fails to remove the omissions or inconsistencies within the time limit set under para 2, the
p.(None): proceedings shall be terminated.
p.(None): (4) Within 75 days from the date of submission of valid documentation under Art. 61, para. 3 the Commission,
p.(None): respectively the committees under para 1, shall perform on-site inspection to establish the competence of the
p.(None): applicant and the ability to meet the stated conformity assessment procedures, including on-site inspection of
p.(None): the subcontractor. A fee fixed by the tariff under Art. 7, para. 1 shall be charged for each on-site inspection carried
p.(None): out.
p.(None): (5) Where during the inspection are found any inconsistencies between the submitted documentation
p.(None): and the conformity assessment requirements, defined in the ordinances under Art. 18, the Executive Director of BDA
...
p.(None): under para 4.
p.(None): (6) The authorization under para 5 shall have a maximum validity term of 5 years. Renewal of the said authorization
p.(None): shall be carried out pursuant to Art. 62, para 2 or para 3.
p.(None): Art. 64. (amend. - SG 38/15, in force from 26.05.2015) (1) When the person applying for conformity
p.(None): assessment authorization produces a certificate of accreditation according to the requirements
p.(None): specified in the ordinance under Art. 18, it shall be assumed that the said person has a functioning
p.(None): quality system, complies with the criteria of independence, impartiality and confidentiality and possesses the
p.(None): competence required.
p.(None): (2) In the cases referred to in para 1 the person shall not produce other documents certifying their conformity with
p.(None): the criteria under para 1.
p.(None): Art. 65. (amend. - SG 38/15, in force from 26.05.2015) Conformity assessment procedures stated in the
p.(None): Ordinance under Art. 18, may also be performed by Notified bodies from other Member States.
p.(None): Art. 66. (amend. - SG 38/15, in force from 26.05.2015) The authorization to conduct conformity assessment
p.(None): shall contain:
p.(None): 1.(amend. - SG 38/15, in force from 26.05.2015) name of the designating body;
p.(None): 2. name/company name, headquarters, business address and representative office of the notified
p.(None):
p.(None): body;
p.(None):
p.(None): 3. medical devices and conformity assessment procedures; 4. date of authorization issue;
p.(None): 5. (amend. - SG 38/15, in force from 26.05.2015) identification number of the notified body.
p.(None):
p.(None):
p.(None): Art. 67. (amend. - SG 38/15, in force from 26.05.2015) (1) Bulgarian Drug Agency shall keep a the register, containing
p.(None): the following:
p.(None): 1. the data under Art. 66;
p.(None): 2. date of authorization suspension and the reason for it.
p.(None): (2) (amend. - SG 38/15, in force from 26.05.2015) Data under para 1 shall be published in the official website of BDA.
p.(None):
p.(None):
p.(None): Art. 67a. (new – SG 38/15, in force from 26.05.2015) (1) Expansion of the authorization scope and renewal of the
p.(None): authorization to expand the scope of the conformity assessment authorization shall be carried out pursuant to Art. 62,
p.(None): para 2 or 3.
p.(None): (2) The Executive Director of BDA shall grant an addition to the authorization under Art. 63, para 5 by an order.
p.(None): Art. 68. (1) (amend. - SG 38/15, in force from 26.05.2015) The notified bodies are obliged to notify BDA in case of:
p.(None): 1. (amend. - SG 38/15, in force from 26.05.2015) changes in the legal status and the organizational
p.(None): structure;
p.(None): 2. (new - SG 38/15, in force from 26.05.2015) changes in the scope of activity except in the cases referred to in Art.
p.(None): 67a, para 1 and changes in the conformity assessment procedures;
p.(None): 3. (prev. text of item 2 - SG 38/15, in force from 26.05.2015) changes in the quality system, management or staff that
p.(None): affect the performance of the conformity assessment procedures;
p.(None): 4. (prev. text of item 3 - SG 38/15, in force from 26.05.2015) change of the subcontractors;
p.(None): 5. (prev. text of item 4 - SG 38/15, in force from 26.05.2015) changes in the circumstances
p.(None):
p.(None): related to the insurance as per Art. 61, para 3, item 7.
p.(None): (2) (amend. - SG 38/15, in force from 26.05.2015) The bodies under para 1 shall submit to the BDA the documents
p.(None): concerning the changes and a shall pay a fee to the amount specified in the tariff under Art.7, para 1.
...
p.(None): planned inspections in accordance with Art. 5, para 1, letter "a" and "b" of Implementing Regulation (EU) № 920/2013.
p.(None): (2) The committees under para 1 shall perform exceptional on-site inspections upon receiving signals, complaints and
p.(None): claims of default of notified bodies or deviation from normal or best practices.
p.(None): (3) When during inspections are found omissions in the work of the notified bodies, the Executive
p.(None): Director of BDA shall issue instructions containing a deadline for removing them.
p.(None): (4) The Executive Director of BDA shall issue an order to restrict or temporarily suspend the authorization removing
p.(None): the omissions under para 3within the set time limit under par. 3
p.(None): Art. 72. (1) (amend. - SG 38/15, in force from 26.05.2015) The the Executive Director of BDA shall withdraw the
p.(None): authorization to conduct conformity assessment by an order if during the inspections it has been found that the
p.(None): notified body:
p.(None): 1. no longer complies with some of the conditions under which the authorization has been
p.(None):
p.(None): issued;
p.(None):
p.(None): 2. is no longer able to proceed with the conformity assessment procedures;
p.(None): 3. does not carry out the conformity assessment procedures in compliance with the
p.(None): requirements of the relevant ordinances as per Art. 18;
p.(None): 4. has not undertaken measures for removing the omissions referred to in Art. 71, para 3 within
p.(None):
p.(None): the fixed term.
p.(None): (2) (revoked - SG 38/15, in force from 26.05.2015)
p.(None):
p.(None):
p.(None): Art. 73. (amend. - SG 38/15, in force from 26.05.2015) The Bulgarian Drug Agency shall notify the
p.(None): European Commission, the other Member States, the countries - parties to the Agreement on the European Economic Area
p.(None): and Swiss Confederation of the authorizations withdrawn as per Art. 72 of the changes made according to Art. 67a, para
p.(None): 1 and Art. 68, para 1.
p.(None): Art. 74. (1) (amend. - SG 38/15, in force from 26.05.2015) The person who has been refused issue of an authorization as
p.(None): per Art. 63, para 2, can submit a new application for authorization not earlier than 6 months from the date of handing
p.(None): the order for refusal.
p.(None): (2) The notified body whose authorization under Art. 72, para 1 has been withdrawn can submit an application for new
p.(None): authorization not earlier than one year from the date of handling the order for authorization withdrawal.
p.(None):
p.(None):
p.(None): Art. 75. (amend. - SG 38/15, in force from 26.05.2015) The refusal to issue a conformity assessment
p.(None): authorization as well as the order for authorization withdrawal can be subject to appeal under the terms of the
p.(None): Administrative Procedure Code.
p.(None):
p.(None):
p.(None): Art. 76. (1) (suppl. - SG 38/15, in force from 26.05.2015)The notified body issues a certificate verifying the
p.(None): essential requirements conformity applicable to the device, with validity specified therein, however of not more than 5
p.(None): years, or makes a reasoned refusal.
p.(None): (2) (amend. – SG 110/08) In case the notified body ascertains that a manufacturer has not fulfilled or
p.(None): has stopped fulfilling the requirements defined in the ordinances as per Art. 18, or the conditions,
p.(None): under which the certificate has been granted have changed, and in consideration of the level of unconformity it
p.(None): withdraws the certificate or suspends temporarily its validity, or restricts its scope, until the manufacturer
p.(None): undertakes appropriate corrective measures and provides the required conformity. (3) (amend. – SG 110/08; amend.
p.(None): - SG 38/15, in force from 26.05.2015) The notified body
p.(None): shall inform BDA in cases of refusal to grant a certificate or temporary suspension of certificate validity, of
p.(None): withdrawal or imposition of restrictions or of amended or supplemented certificates.
p.(None): (4) (new - SG 38/15, in force from 26.05.2015) In the cases under par. 3 the notified body shall provide additional
p.(None): information upon request by the BDA and the documents requested by BDA.
p.(None): (5) (amend. – SG 110/08; prev. text of para 4, amend. - SG 38/15, in force from 26.05.2015) The Bulgarian Drug
p.(None): Agency shall inform the regulatory authorities of the other Member States, the regulatory authorities of the
p.(None): states - parties to the Agreement on the European Economic Area and of Swiss Confederation and the European Commission
p.(None): of the cases under par. 3.
p.(None):
p.(None):
p.(None): Art. 76a. (new – SG 110/08; amend. - SG 38/15, in force from 26.05.2015) The Notified bodies shall be obliged to
p.(None): provide to notified bodies, determined by other Member States, information on refused certificates, on
p.(None): certificates the validity of which has been suspended temporarily, on withdrawn certificates and, upon request, on
p.(None): issued certificates.
p.(None):
p.(None): Chapter five.
p.(None): TRADE IN MEDICAL DEVICES (TITLE AMEND. - SG 60/11, IN FORCE FROM 05.08.2011)
p.(None):
p.(None): Art. 77. (amend. – SG 54/12) (1) Wholesale trade in medical devices on the territory of the
p.(None):
p.(None): Republic of Bulgaria may be carried out by natural or legal persons registered as traders under Commerce
p.(None): Act or the legislation of a Member State or a contracting state of the Agreement on the European
p.(None): Economic Area, or the Swiss Confederation, holding an authorisation for wholesale trade in medical devices issued by
p.(None): BDA or another document certifying the right to trade in medical devices, issued by a competent authority of the
p.(None): respective state.
p.(None): (2) The manufacturers located in the territory of the Republic of Bulgaria may carry out commercial
p.(None): transaction with devices manufactured by them without the document referred to in Para 1.
p.(None):
p.(None):
...
p.(None): a) the premises meet the requirements for storage of medical devices from the register under Para 1, Item 2 depending
p.(None): on their specifics and instructions of the manufacturer determined in the usage directions, and
p.(None): b) own or possess transportation means allowing their proper storage during distribution and transportation;
p.(None): 2. information of the name, permanent address and address for correspondence with the person determined to be
p.(None): responsible for the premises for storage and trade in medical devices and a copy of the contract by virtue of which
p.(None): have risen his legal relations with the applicant.
p.(None):
p.(None):
p.(None): Art. 78a. (new – SG 54/12) Where the persons referred to in Art. 77 hold a document certifying their right to wholesale
p.(None): trade in medical devices issued by a competent authority of a Member State or a contracting state to the Agreement on
p.(None): the European Economic Area, or the Swiss Confederation, and have premises for storage of medical devices on the
p.(None): territory of the Republic of Bulgaria, they shall file with BDA:
p.(None): 1. a notification form in a form approved by the executive director of BDA;
p.(None): 2. a copy of the document attesting their right to wholesale trade, accompanied by a translation in Bulgarian;
p.(None): 3. a list of the categories medical devices according to the nomenclature system BDS EN ISO 15225 for categorisation
p.(None): of the medical devices and their respective manufacturers on paper and magnetic career;
p.(None): 4. the documentation referred to in Art. 78, Para 2.
p.(None):
p.(None): Art. 79. (amend. – SG 54/12) (1) The Bulgarian Drug Agency shall check the documentation under Art. 78 and 78a. In
p.(None): cases of deficiencies in the documentation BDA shall notify the applicant in writing and shall provide a time limit for
p.(None): their remedy.
p.(None): (2) Within 30 days from the date of submission of the documentation under Art. 78 the executive
p.(None): director of BDA shall issue an authorisation for wholesale trade in medical devices to the persons under
p.(None): Art. 78, Para 1, and the information of their premises for storage and trading and the list of the categories of
p.(None): medical devices shall be recorded in the register under Art. 81.
p.(None): (3) The time limit under Para 2 shall be suspended from the date of the notification under Para 1 until the remedy of
p.(None): the deficiencies.
p.(None): (4) Within 7 days from the notification under Art. 78a the Bulgarian Drug Agency shall record in the register under
p.(None): Art. 81 the information of the notification.
p.(None):
p.(None):
p.(None): Art. 80. (amend. – SG 54/12) (1) In case of change of the address of the premises for storage and trade in medical
p.(None): devices on the territory of the Republic of Bulgaria the persons referred to in Art. 78 shall file with BDA an
p.(None): application for amendment of the authorization under Art. 79, Para 2, and the persons referred to in Art. 78a – a
p.(None): notification of the change. The application or the notification shall be accompanied by the documentation related to
p.(None): the change and a document of paid fees, in the case of the persons referred to in Art. 78a, in amount determined in the
p.(None): tariff under Art. 7, Para 1.
p.(None): (2) (new - SG 60/11, in force from 05.08.2011) The wholesale traders of medical devices shall file with EAM a
p.(None): notification accompanied by the change-related documents in cases of the following changes:
p.(None): 1. the legal status, seat and/or business address of the trader;
p.(None): 2. the list of types of medical devices being traded and their respective manufacturers; 3. the name and/or address of
p.(None): the authorized representative as per Art. 78, para 5.
p.(None): (3) (suppl. – SG 110/08; prev. text of Para 02 - SG 60/11, in force from 05.08.2011) To the application form under
p.(None): para 1 shall also be appended the documents related to the change and a document of a collected fee of the
p.(None): amount, determined by the tariff under Art. 7, par. 1.
p.(None): (4) (prev. text of Para 03 - SG 60/11, in force from 05.08.2011) Amendment certificates or
p.(None): authorizations shall be issued by the Executive Director of BDA within 15 days from the submission of application form
p.(None): under para 1. In case of change in the address of the premises for storage and wholesale trade in medical devices, the
p.(None): term shall be prolonged by 15 days.
p.(None): (5) (prev. text of Para 04 - SG 60/11, in force from 05.08.2011) The persons under para 1 are obliged, within 10
p.(None): days after termination of their activities relating to wholesale trade in medical devices, to notify in
p.(None): writing the Executive Director of BDA.
p.(None): (6) (prev. text of Para 05 - SG 60/11, in force from 05.08.2011) In the cases referred to in para 4, the Executive
p.(None): Director of BDA shall terminate the effect of the issued authorization or invalidate the issued certificate for
p.(None): wholesale trade by an order.
p.(None):
p.(None):
p.(None): Art. 80a. (new – SG 54/12) (1) Within 10 days from termination of their activity related to the trade in medical
p.(None): devices on the territory of the Republic of Bulgaria the persons referred to in Art. 78 and 78a shall notify in writing
p.(None): the executive director of BDA.
p.(None): (2) In the cases of Para 1 the executive director of BDA shall issue an order for terminating the validity of the
p.(None): issued authorization under Art. 79, Para 2. Within 7 days from the issue of the order for termination of the
p.(None): authorization the Bulgarian Drug Agency shall record into the register under Art. 81 the date of termination of the
p.(None): authorization of the trader under Art. 78.
p.(None): (3) The Bulgarian Drug Agency shall record into the register under Art. 81 the date of termination of
p.(None): the activity of the persons under Art. 78a.
p.(None):
p.(None): Art. 81. (amend. – SG 54/12) The Bulgarian Drug Agency keeps a register of the persons referred to in
p.(None): Art. 78 and 78a, containing:
p.(None): 1. (amend. – SG 54/12) number and date of the certificates or authorizations for wholesale trade in medical devices to
p.(None): the persons under Art. 78;
p.(None): 2. (amend. – SG 54/12) name, headquarters and registered address of the persons under Art. 78
p.(None):
p.(None): and 78a;
p.(None):
p.(None): 3. (amend. – SG 54/12) termination date of authorizations under Art. 79, Para 2; 4. (amend. – SG 54/12) address of the
p.(None): premises for storage of medical devices;
p.(None): 5. (amend. – SG 54/12) name and address of the persons referred to in Art. 78, para 2, item 2; 6. (amend. – SG 54/12) a
p.(None): list of the categories of traded medical devices;
p.(None): 7. (new – SG 54/12) changes of the recorded circumstances.
p.(None):
p.(None):
p.(None): Art. 82. (1) (amend. – SG 54/12) The traders in medical devices, trading on the territory of the Republic of Bulgaria,
p.(None): are obliged to trade only in medical devices the shelf life of which has not expired and which have:
p.(None): 1. affixed CE marking according to the requirements of Art. 15;
p.(None): 1a. (new – SG 54/12) affixed batch/serial number on the packaging, where applicable;
p.(None): 2. (amend. – SG 110/08; amend. - SG 38/15, in force from 26.05.2015) affixed identification number of the notified body
p.(None): as per Art. 63, para 4, where the procedures, determined in the provisions of Art. 18 require its displaying;
p.(None): 3. affixed name and registered address of the manufacturer and/or their authorized representative
p.(None): and the importer;
p.(None): 4. instructions for use, except for devices that the present Act does not cover.
p.(None): (2) (amend. – SG 54/12) The persons under para 1 are obliged to maintain the premises for storage of
...
p.(None): and under Art. 83b, and take samples and specimens of the devices under the terms of Art. 93, para 3.
p.(None): (3) In case during the inspection it is established that medical devices do not comply with the requirements set out in
p.(None): Art. 82, para 1, items 1, 2 and 3, or that their shelf life has expired, the Executive Director of BDA shall order
p.(None): the devices to be blocked and withdrawn from the market and/or their destruction.
p.(None): (4) In case it is established that the premises for storage and trade do not meet the requirements determined by the
p.(None): manufacturer regarding certain device, the officials under para 1 shall give instructions and fix a term for
p.(None): eliminating these non-conformities.
p.(None): (5) In case the inspection ascertains that there are shortcomings or imperfections in the system
p.(None):
p.(None): as per Art. 82, para 3 or in the documentation of Art. 83b, the officials referred to in para 1 shall give instructions
p.(None): and fix a term for eliminating them.
p.(None): (6) In case the non-conformities, shortcomings and imperfections are not eliminated within the terms under para 4 and
p.(None): 5, the officials referred to in para 1 shall present a statement to the Executive Director of BDA, including a proposal
p.(None): to withdraw the authorization for wholesale trade, and in respect of the persons referred to in Art. 78a –
p.(None): removal from the register under Art. 81 and closing of their premises for storage and trading.
p.(None): (7) The orders of the Executive Director of BDA under para 3 and 6 may be appealed under the terms of the
p.(None): Administrative Procedure Code, and the appeal shall not suspend their implementation.
p.(None):
p.(None):
p.(None): Art. 85. (amend. – SG 54/12) The Bulgarian Drug Agency shall notify the regulatory authority of the other Member State
p.(None): or contracting state to the Agreement on the European Economic Area, or of the Swiss Confederation, that has issued the
p.(None): document certifying the right to wholesale trade in medical devices, of any violations related to wholesale trade in
p.(None): medical devices on the territory of the Republic of Bulgaria and shall provide information at the request of the
p.(None): persons under Art. 78.
p.(None):
p.(None):
p.(None): Chapter six.
p.(None): MARKET SUPERVISION
p.(None):
p.(None): Art. 86. (1) (suppl. – SG, 84/2012, in force from 02.01.2013) Market supervision is exercised to ensure that the
p.(None): medical devices placed on the market and/or put into service meet the requirements of the Act and the ordinances as per
p.(None): Art. 18 of this act and/or Chapter Five “a” and of the ordinance under Art. 21e, Para. 1 of the Act on
p.(None): Protection of the Dangerous Impact of Chemical Substances and Mixtures.
p.(None): (2) Market supervision on the territory of the Republic of Bulgaria is carried out by BDA through
p.(None): inspectors and experts appointed by an order of the Executive Director.
p.(None):
p.(None):
p.(None): Art. 87. (1) Market control is carried out by means of:
p.(None): 1. inspections of devices placed on the market and/or put into service; 2. taking samples and specimens of the devices
p.(None): and testing.
p.(None): (2) Trials of medical devices may not be carried out by the notified bodies involved in the conformity
p.(None): assessment of the same devices.
p.(None):
p.(None):
p.(None): Art. 88. Inspections of medical devices placed on the market and/or put into service shall be carried out according to:
...
p.(None): medical devices manufactured by them and placed on the market/put into service on the territory of Member States, of
p.(None): states from the European Economic Area and third countries, as well as to have at their disposal the mechanisms for
p.(None): implementation of the necessary corrective actions.
p.(None): (2) The system under para 1 shall be applied to medical devices which: 1. have CE marking;
p.(None):
p.(None): 2. do not have CE marking in case the incident or the potential incident relating to them under Art. 106, para 1 and 2
p.(None): requires performance of corrective actions applicable to devices as per item 1.
p.(None): (3) The system shall not apply to devices intended for clinical trials and devices for operation assessment.
p.(None): (4) The system under para 1 includes examination of safety of devices under para 2 that have been placed on the market
p.(None): and/or put into service by way of:
p.(None): 1. collecting, documenting and analyzing reports for events under Art. 105 by medical experts, patients, persons
p.(None): installing, maintaining and calibrating the devices, and BDA;
p.(None): 2. analysis of results from additional tests on the devices carried out by the manufacturer; 3. collecting, recording
p.(None): and analyzing data from scientific literature.
p.(None):
p.(None):
p.(None): Art. 104. (1) (prev. Art. 104 – amend. SG 110/08; amend. – SG 54/12) Doctors, dentists other medical experts, as
p.(None): well as persons installing, maintaining and calibrating the devices are obliged to inform immediately the
p.(None): BDA about events as per Art. 105 at the sites under Art. 83, para 1, items 2 regarding the medical establishments
p.(None): under the Medical Establishments Act.
p.(None): (2) (new – SG 110/08) The Bulgarian Drug Agency shall provide to the manufacturer or to his/her
p.(None): authorized representative the information under par. 1 within three days after its receipt.
p.(None):
p.(None):
p.(None): Art. 105. (1) The manufacturer shall inform BDA of any trouble or deterioration in the characteristics of
p.(None): the device manufactured by him/her, and/or in its operation, as well as of incomplete or inaccurate information on its
p.(None): label or instructions for use, which has caused death or serious health damage, or which is likely to cause death or
p.(None): serious health damage to a patient, medical expert or third persons on the territory of the Republic of Bulgaria.
p.(None): (2) Manufacturers shall also inform BDA of any technical or medical cause related to the device’s
p.(None): characteristics or operation, which leads to regular withdrawal from the market of the same type of
p.(None): devices due to the reasons specified in para 1.
p.(None):
p.(None):
p.(None): Art. 106. (1) The manufacturer shall provide BDA with an advance report within 10 days of receipt of information about
p.(None): an event as per Art. 105 which has caused death or serious health damage, and hereafter referred to as incident.
p.(None): (2) The manufacturer shall submit to BDA an advance report within 30 days of receipt of information
p.(None): about an event under Art. 105 which could have caused death or serious health damage that were averted due to
p.(None): favourable circumstances or medical intervention, and hereafter referred to as potential incident.
p.(None): (3) (amend. - SG 38/15, in force from 26.05.2015) In case the incident or potential incident concerns
p.(None): devices of class IIa, Iib or III, or in vitro diagnostic medical devices from List A and List B, or self-testing
p.(None): devices, and has occurred in a third state, the manufacturer shall submit to BDA, within the term under para 1 or 2, an
p.(None): advance report in those cases where a notified body as per Art. 63, para 4 has carried out conformity assessment of the
p.(None): device related to the incident.
p.(None): (4) In case the incident or potential incident concerns devices of class I or in vitro diagnostic medical devices that
p.(None): are not from List A and List B and are not for self-testing, and has occurred in a third state, the manufacturer shall
p.(None): submit to BDA, within the term under para 1 or 2, an advance report in those cases where the manufacturer or their
p.(None): authorized representative is registered at BDA according to Chapter II.
p.(None):
p.(None): Art. 107. When the incident or potential incident is a result of combined use of two or more individual devices
p.(None): and/or accessories produced by different manufacturers, each manufacturer shall provide BDA with an individual
p.(None): report under Art. 106.
p.(None):
p.(None):
p.(None): Art. 108. Immediately upon receiving information for an incident or potential incident, manufacturers shall
p.(None): notify their authorized representative as per Art. 10, para 2, the wholesale trader, and the notified body that
p.(None): carried out the assessment of the device’s conformity with essential requirements.
p.(None):
p.(None):
p.(None): Art. 109. (1) The Bulgarian Drug Agency maintains a system for registration, analysis and summarizing of
p.(None): incidents or potential incidents related to medical devices.
p.(None): (2) The Bulgarian Drug Agency publishes on its web page the manuals for tracing the safety of medical devices, issued
p.(None): by the European Commission and the European Medicines Agency.
p.(None):
p.(None):
p.(None): Art. 110. (1) The Bulgarian Drug Agency registers in the system under Art. 109, para 1 the data from the advance report
p.(None): of the manufacturer and assesses the provided information.
p.(None): (2) The Bulgarian Drug Agency carries out supervision on the manufacturer’s procedures regarding the
p.(None): investigation of the incident or potential incident and may issue directions and instructions.
p.(None): (3) During the investigation of the incident or potential incident BDA assists the manufacturer, where necessary, to
p.(None): contact:
p.(None): 1. the notified body that has performed conformity assessment;
p.(None): 2. regulatory authorities of other affected Member States or states from the European Economic
p.(None): Area;
p.(None): 3. regulatory authorities of Member States or states from the European Economic Area for
p.(None): medical devices in the case of incidents or potential incidents with devices as per Art. 3, item 2, 3 and 4; 4. other
p.(None): manufacturers in the cases referred to in Art. 107;
p.(None): 5. users of the device or third persons.
p.(None):
p.(None):
p.(None): Art. 111. In case the advance report as per Art. 106 indicates corrective actions, or contains the conclusion that the
p.(None): incident threatens the safety of patients, medical experts or third persons however corrective actions have not
p.(None): been defined yet, BDA sends a report to the regulatory authorities of Member States, states from the
p.(None): European Economic Area, and the European Commission.
p.(None):
p.(None):
p.(None): Art. 112. (1) Within three months from the submission of the report as per Art. 106, the manufacturer
p.(None): draws in and presents to BDA a final report in a form approved by the Executive Director.
p.(None): (2) The report under para 1 may contain one of the following conclusions: 1. it is not necessary to take any measures;
p.(None): 2. (amend. – SG 54/12) additional tracing of the device or batch of devices that have been put into service at the
...
p.(None): written recommendation prepared by the manufacturer;
p.(None): 4. corrective actions in the course of future production;
p.(None):
p.(None): 5. corrective actions on the device put into service at sites as per item 2;
p.(None): 6. withdrawal of the device or batch of devices that have been placed on the market and/or put into service.
p.(None):
p.(None):
p.(None): Art. 113. (1) In the cases referred to in Art. 112, para 2, item 2, BDA shall exercise control over the manufacturer’s
p.(None): activity on the territory of the Republic of Bulgaria.
p.(None): (2) In the cases of Art. 112, para 2, item 3, BDA shall assess the contents of the written
p.(None): recommendation and discuss with the manufacturer the addressees of the recommendation and its way of distribution.
p.(None): (3) In the cases referred to in Art. 112, para 2, item 5, BDA can carry out an inspection on the
p.(None): spot.
p.(None): (4) The Executive Director of BDA shall issue an order that the manufacturer blocks or
p.(None): withdraws the device or batch of devices with which the incident or potential incident has happened, in case it is
p.(None): ascertained that the manufacturer has not:
p.(None): 1. carried out corrective actions within the term specified by him/her in the report under Art.
p.(None): 112;
p.(None): 2. withdrawn the device or batch of devices from the market within the term specified by
p.(None): him/her in the report as per Art. 112;
p.(None): (5) The terms and procedures for blocking, withdrawal and/or destruction of devices which do not meet the requirements
p.(None): of this Act shall be determined by an ordinance of the Minister of Health.
p.(None):
p.(None):
p.(None): Art. 114. (1) The Bulgarian Drug Agency shall publish on its web site a list of the devices included
p.(None): in the ordinance under Art. 113, para 4.
p.(None): (2) In those cases where the devices under para 1 are being sold at sites as per Art. 83, para 2, BDA informs the
p.(None): public through BTA and the mass media.
p.(None): (3) The Executive Director of BDA issues a report on the incident that has occurred or the potential
p.(None): incident in cases referred to in Art. 112 and forwards a copy to the European Commission and the regulatory authorities
p.(None): of the Member States.
p.(None):
p.(None):
p.(None): Art. 115 (1) Any direct notice to BDA regarding an incident or potential incident with medical device on the territory
p.(None): of the Republic of Bulgaria, handed by an identified person in writing, shall be documented in the system under
p.(None): Art.109.
p.(None): (2) Within three days after receiving the notice for the incident or potential incident under para 1 BDA informs the
p.(None): manufacturer so that he/she undertakes the necessary measures defined under Art.106 - 108 and Art.112.
p.(None):
p.(None):
p.(None): Art. 116. BDA can be coordinating regulatory authority:
p.(None): 1. in the case of incident or potential incident which has occurred on the territory of more than one Member State or a
p.(None): state from the European Economic Area, and
p.(None): 2. in the event that the incident or the potential incident is registered for the first time on the territory of the
p.(None): Republic of Bulgaria, or
p.(None): 3. where the body which has carried out the conformity assessment of the device with the essential
p.(None): requirements has obtained an authorization under Chapter IV, if the incident or the potential incident has occurred
...
Searching for indicator substance:
(return to top)
p.(None): groups determined in the ordinances as per Art.18, depending on the potential risk related to them.
p.(None): (3) Depending on the potential risk related to them the medical devices under para.1, item 3 are
p.(None):
p.(None): grouped into class I, IIa, IIb and III according to classification rules set out in the ordinances
p.(None): under Art.18.
p.(None): (4) (amend. – SG 110/08, in force from 21.03.2010) In case the manufacturer and the notified authority determined
p.(None): pursuant to Chapter IV have different opinions regarding the implementation of the classification rules under
p.(None): para.3, the Bulgarian Drug Agency (BDA) shall take a decision. When it deems it appropriate and when
p.(None): the conditions under Art. 6a, item 1 or 2 are present, the BDA shall prepare a justified request to the
p.(None): European Commission for undertaking relevant measures.
p.(None): (5) (amend. – SG 110/08, in force from 21.03.2010) In case this is explicitly required, the
p.(None): classification rules under para.3 to be brought in compliance with new technologies development and/or with
p.(None): information received according to Chapter VII, BDA shall work out a reasoned request for undertaking the
p.(None): necessary measures which is to be submitted to the European Commission.
p.(None):
p.(None):
p.(None): Art. 3. The requirements for medical devices provided for in the present Act also apply to: 1. accessories to the
p.(None): devices;
p.(None): 2. devices including as an integral part a substance which, if used separately, may be considered to be a medicinal
p.(None): product within the meaning of the Medicinal Products in Human Medicine Act and which has an auxiliary effect on the
p.(None): organism with regards to the principal intended action of the device; 3. devices including as an integral part a
p.(None): substance obtained from human blood or plasma
p.(None): which, if used individually, may be considered a component of a medicinal product or a medicinal product
p.(None): under the Medicinal Products in Human Medicine Act and which has an auxiliary effect on the organism with regards to
p.(None): the principal intended action of the device;
p.(None): 4. devices with the use of which medicinal products are being applied;
p.(None):
p.(None):
p.(None): Art. 4. (1) In case certain product comes within the purview of this Act and the ordinance as per Art.7 of the
p.(None): Technical Requirements to Products Act, regarding personal protection devices, introducing Directive EEC 89/686 of the
p.(None): Council, the relevant general safety requirements set out in the ordinance shall apply to the said product.
p.(None): (2) (In force from 29.12.2009; amend. – SG 110/08, in force from 21.03.2010) In case the medical device
p.(None): comes also within the purview of the ordinance under Art. 7 of the Technical Requirements to Products
p.(None): Act, introducing Directive EU 2006/42 of the European Parliament and of the Council of 17 May 2007 regarding the
p.(None): machines and amending the Directive 95/16/EC and there is a risk of its application, the relevant essential safety
p.(None): requirements set out in it shall apply to it, provided that these requirements are more specific than the ones provided
p.(None): for in the ordinance as per Art.18.
p.(None): (3) (new – SG, 84/2012, in force from 02.01.2013) Where a medical device under Art. 2, Para. 1, p. 1 and 3 falls in the
p.(None): application scope of Chapter Five “a” of the Act on Protection of the Dangerous Impact of Chemical Substances and
...
p.(None): bodies of the affected member States or the regulatory authorities of the states of the European
p.(None): Economic Area, participating in the testing, of the undertaken measures and of the amendments of the plan and shall
p.(None): present the justifications thereof.
p.(None): (5) (new – SG 110/08) In the cases under Art. 3, item 2 the BDA shall notify the regulating bodies of the other member
p.(None): States, the regulatory authorities of the states of the European Economic
p.(None):
p.(None): Area and the European Commission of the premature termination of the clinical testing and shall present the
p.(None): justifications thereof.
p.(None):
p.(None):
p.(None): Art. 56. (1) (amend. – SG 110/08, in force from 21.03.2010) The assignor of the clinical testing is obliged to present
p.(None): to BDA upon request documentation containing:
p.(None): general description of the device and of its purpose of use;
p.(None): 2. design drawings, production methods, including the ones related to sterilization, diagrams of components and
p.(None): details, ways of connection, etc.;
p.(None): 3. description and explanations of the drawings and diagrams and the operation of the medical
p.(None): device;
p.(None): 4. results from the risk analysis and a list of the applied fully or partially standards as per Art.
p.(None): 13, para 1 and a description of the adopted technical decisions for ensuring essential requirements
p.(None): conformity, where these standards have not been applied;
p.(None): 5. results of tests, carried out by a regulatory body of a Member State or by the European Medicines
p.(None): Agency for assessment of the quality and safety of the substance in the meaning of Art. 3, item 2, 3 or 4, as well as
p.(None): for assessment of its benefit in terms of device purpose of use;
p.(None): 6. the undertaken measures for reduction of the risk of infections, included in the risk management
p.(None): system in case of a device as per Art. 2, par. 1, item 3, for the manufacturing of which non-viable animal tissue or
p.(None): non-viable products, produced from animal tissues have been used;
p.(None): 7. the results of the engineering calculations and the accomplished inspections and technical
p.(None): tests.
p.(None): (2) (amend. – SG 110/08, in force from 21.03.2010) The assignor of the clinical test is obliged
p.(None): to keep the documentation of par. 1 for a period of 15 years after the accomplishment of the clinical test
p.(None): – for the devices under Art. 2, para 1, item 2, and for implantable devices under Art. 2, para 1, item 3, and 5 years
p.(None): for the devices of Art. 2, par. 1, item 1.
p.(None): (3) (amend. – SG 110/08, in force from 21.03.2010) The manufacturer is obliged to ensure a production process whereby
p.(None): the medical devices intended for clinical trials are produced in accordance with the documentation of par. 1.
p.(None):
p.(None):
p.(None): Art. 57. (1) Within 90 days from completion of the clinical trial, the assignor presents to BDA and the respective
p.(None): ethics committee a final report containing a description of methodology and organization, critical assessment
p.(None): and statistical analysis of received data.
p.(None): (2) The report under para 1 shall be signed by the assignor and by all investigators. If one of the investigators
p.(None): refuses to sign it, he/she shall enclose his/her reasons in writing.
...
p.(None): a) concerning a physiological or pathological state, or b) concerning a congenital abnormality, or
p.(None): c) to determine the safety and compatibility with potential recipients, or d) to monitor therapeutic measures.
p.(None): In vitro diagnostic medical devices are also considered to be the devices for self-testing, specimen
p.(None): receptacles, except for the products for general laboratory use unless such products, in view of their
p.(None): characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic
p.(None): examinations.
p.(None): 13. "In vitro diagnostic device for performance evaluation" means any in vitro diagnostic device intended
p.(None): by the manufacturer to be subject to one or more performance evaluation studies in
p.(None):
p.(None): laboratories for medical analyses or in other appropriate environments outside production premises;
p.(None): 14. "Informed consent" means a decision, which must be written, dated and signed, to take part in a clinical trial,
p.(None): taken freely after being duly informed of its nature, significance, implications and risks and appropriately
p.(None): documented, by any person capable of giving consent or, where the person is not capable of giving consent,
p.(None): by his or her legal representative; if the person concerned is unable to write, oral consent in the presence of at
p.(None): least one witness may be given in exceptional cases.
p.(None): 15. "Calibrator and control material" refer to any substance, material or Art. intended by their manufacturer either to
p.(None): establish measurement relationships or to verify the performance characteristics of a device in conjunction with the
p.(None): intended use of that device.
p.(None): 15a. (new – SG 110/08, in force from 21.03.2010) "Clinical data" is the information, gathered in the course of device
p.(None): usage concerning its safety and/or its functioning. Clinical data shall be obtained from:
p.(None): a) the results, obtained in the course of carrying out of clinical testing or the tested medical device,
p.(None): or
p.(None): b) data of clinical test/tests or data from other studies, published in the research papers, on similar
p.(None): medical device, the equivalency or which with the tested device can be proven, or
p.(None): c) published and/or non-published reports of another clinical examination of the tested device or of a similar medical
p.(None): device, the equivalency of which with the tested device can be proven.
p.(None): 16. "Coordinating investigator" is the person who coordinates the investigators during multi-centre
p.(None): clinical trials.
p.(None): 17. "Corrective actions" may include withdrawal of the device which has been put into service; issue of recommendations
p.(None): in writing specifying the measures that shall be undertaken; further tracing or modification of the device that
p.(None): has been put into service with the purpose of characteristics and performance improvement; amendment of the
p.(None): project; change of individual components of the device or change in the production process in the event of future
p.(None): manufacturing of such Art.s; amendment of the contents of the label or the instruction for use, etc.
...
Searching for indicator usage:
(return to top)
p.(None): transaction with devices manufactured by them without the document referred to in Para 1.
p.(None):
p.(None):
p.(None): Art. 78. (amend. – SG 54/12) (1) Natural and legal persons registered under the Commerce Act or the legislation of a
p.(None): Member State or a contracting state to the Agreement on the European Economic Area, or the Swiss Confederation,
p.(None): wishing to obtain an authorisation for wholesale trade in medical devices shall file an application with
p.(None): BDA in a form approved by the executive director of BDA, accompanied by:
p.(None): 1. information of UIC of the persons registered under the Commerce Act and of the persons registered in a Member State
p.(None): or a contracting state to the Agreement on the European Economic Area, or the Swiss Confederation – information
p.(None): certifying their commercial registration;
p.(None): 2. a list of the categories medical devices according to the nomenclature system BDS EN ISO 15225 on the
p.(None): categorisation of the medical devices and their respective manufacturers on paper or magnetic career;
p.(None): 3. a document of paid fee in amount determined in the tariff referred to in Art. 7, Para 1.
p.(None): (2) If they have available premises for storage of medical devices on the territory of the Republic of
p.(None): Bulgaria, the persons under para 1 shall specify their address in the application. In this case the following documents
p.(None): shall also be enclosed to the documentation under para 1:
p.(None): 1. a statement that:
p.(None): a) the premises meet the requirements for storage of medical devices from the register under Para 1, Item 2 depending
p.(None): on their specifics and instructions of the manufacturer determined in the usage directions, and
p.(None): b) own or possess transportation means allowing their proper storage during distribution and transportation;
p.(None): 2. information of the name, permanent address and address for correspondence with the person determined to be
p.(None): responsible for the premises for storage and trade in medical devices and a copy of the contract by virtue of which
p.(None): have risen his legal relations with the applicant.
p.(None):
p.(None):
p.(None): Art. 78a. (new – SG 54/12) Where the persons referred to in Art. 77 hold a document certifying their right to wholesale
p.(None): trade in medical devices issued by a competent authority of a Member State or a contracting state to the Agreement on
p.(None): the European Economic Area, or the Swiss Confederation, and have premises for storage of medical devices on the
p.(None): territory of the Republic of Bulgaria, they shall file with BDA:
p.(None): 1. a notification form in a form approved by the executive director of BDA;
p.(None): 2. a copy of the document attesting their right to wholesale trade, accompanied by a translation in Bulgarian;
p.(None): 3. a list of the categories medical devices according to the nomenclature system BDS EN ISO 15225 for categorisation
p.(None): of the medical devices and their respective manufacturers on paper and magnetic career;
p.(None): 4. the documentation referred to in Art. 78, Para 2.
p.(None):
p.(None): Art. 79. (amend. – SG 54/12) (1) The Bulgarian Drug Agency shall check the documentation under Art. 78 and 78a. In
p.(None): cases of deficiencies in the documentation BDA shall notify the applicant in writing and shall provide a time limit for
p.(None): their remedy.
...
p.(None): characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic
p.(None): examinations.
p.(None): 13. "In vitro diagnostic device for performance evaluation" means any in vitro diagnostic device intended
p.(None): by the manufacturer to be subject to one or more performance evaluation studies in
p.(None):
p.(None): laboratories for medical analyses or in other appropriate environments outside production premises;
p.(None): 14. "Informed consent" means a decision, which must be written, dated and signed, to take part in a clinical trial,
p.(None): taken freely after being duly informed of its nature, significance, implications and risks and appropriately
p.(None): documented, by any person capable of giving consent or, where the person is not capable of giving consent,
p.(None): by his or her legal representative; if the person concerned is unable to write, oral consent in the presence of at
p.(None): least one witness may be given in exceptional cases.
p.(None): 15. "Calibrator and control material" refer to any substance, material or Art. intended by their manufacturer either to
p.(None): establish measurement relationships or to verify the performance characteristics of a device in conjunction with the
p.(None): intended use of that device.
p.(None): 15a. (new – SG 110/08, in force from 21.03.2010) "Clinical data" is the information, gathered in the course of device
p.(None): usage concerning its safety and/or its functioning. Clinical data shall be obtained from:
p.(None): a) the results, obtained in the course of carrying out of clinical testing or the tested medical device,
p.(None): or
p.(None): b) data of clinical test/tests or data from other studies, published in the research papers, on similar
p.(None): medical device, the equivalency or which with the tested device can be proven, or
p.(None): c) published and/or non-published reports of another clinical examination of the tested device or of a similar medical
p.(None): device, the equivalency of which with the tested device can be proven.
p.(None): 16. "Coordinating investigator" is the person who coordinates the investigators during multi-centre
p.(None): clinical trials.
p.(None): 17. "Corrective actions" may include withdrawal of the device which has been put into service; issue of recommendations
p.(None): in writing specifying the measures that shall be undertaken; further tracing or modification of the device that
p.(None): has been put into service with the purpose of characteristics and performance improvement; amendment of the
p.(None): project; change of individual components of the device or change in the production process in the event of future
p.(None): manufacturing of such Art.s; amendment of the contents of the label or the instruction for use, etc.
p.(None): 14. "Critical analysis" means:
p.(None): a) short description of the medical device – intended operation, type, characteristics; b) analysis of the relevant
p.(None): literature and all the information available;
p.(None): c) critical analysis of the damages identified while using the device, the related risks and suitable
p.(None): safety measures as regards to patients, medical personnel and third parties;
...
Health / Mentally Disabled
Searching for indicator disability:
(return to top)
p.(None): 20. "Personal protective equipment" shall mean any equipment or device designed to protect a person against one or
p.(None): more hazards likely to endanger his safety and health. Personal protective equipment shall also be considered
p.(None): the following:
p.(None): a) entirety of equipment or devices or means interrelated by the manufacturer for the purpose of protecting a person
p.(None): from one or numerous hazards which may occur at the same time;
p.(None):
p.(None): b) protective equipment or device connected with a personal device with no protective function in a manner allowing or
p.(None): not separation, utilized by a person for a certain activity.
p.(None): c) replaceable compounds of a personal protective device, which are essential for its proper functioning
p.(None): and which are being used solely for the same personal device.
p.(None): 21. (amend. – SG 110/08, in force from 21.03.2010) "Medical device" means any instrument, apparatus, appliance,
p.(None): software, material or other device, whether used alone or in combination, including software, designated by the
p.(None): manufacturer to be used specifically for diagnostic and/or therapeutic purposes and required for its proper
p.(None): functioning, which does not achieve its principal intended action by pharmacological, chemical, immunological or
p.(None): metabolic means, but which may be assisted in its function by such means and which is intended by the
p.(None): manufacturer to be used for human beings for the purpose of:
p.(None): a) diagnosis, prevention, monitoring, treatment or alleviation of diseases;
p.(None): b) diagnosis, monitoring, treatment, alleviation or compensation of trauma or disability;
p.(None): c) investigation, replacement or modification of the anatomy or of a physiological process; d) control of conception
p.(None): process.
p.(None): 22. (amend. – SG 110/08, in force from 21.03.2010) "Device intended for clinical testing" means any
p.(None): medical device referred to in Art. 2, para 1, items 2 and 3, intended to be used by a medical specialist of by another
p.(None): specialist, having relevant for the testing purposes qualification, for conducting clinical testing in the medical
p.(None): establishment in order to achieve the objective referred to in Art. 32.
p.(None): 23. (amend. – SG 110/08) "Custom-made device" е means any medical device referred to in Art. 2, para 1, items 2 or 3,
p.(None): specifically made in accordance with a written prescription by a medical expert or a person with relevant
p.(None): professional qualification, which gives, under his/her responsibility, specific design characteristics of the
p.(None): device and is intended to be used only for an individual named patient.
p.(None): Mass-produced devices, adapted in order to meet the specific requirements of the medical practitioner or of
p.(None): any other trained user are not considered to be custom-made devices.
p.(None): 24. "Multi-centre clinical trial" means a clinical trial conducted according to a single trial plan but at more than
p.(None): one investigation centre/medical establishment, and therefore by more than one investigator. The
p.(None): investigation centres may be located in the territory of a single Member State, in a number of Member States
p.(None): and/or in Member States and third countries;
...
Health / Mentally Incapacitated
Searching for indicator incapable:
(return to top)
p.(None): consequences for him/her;
p.(None): 3. has personally expressed written informed consent to take part in the investigation.
p.(None): (2) If the individual is unable to write, oral consent in the presence of at least one witness may be given. The
p.(None): witness shall certify in writing that the person has expressed informed consent to take part in the clinical trial in
p.(None): person.
p.(None): (3) The informed consent pursuant to para 1, item 3, and para 2 can only be given by a capable person who understands
p.(None): the nature, significance, scope, consequences, and potential risks of the clinical trial. Informed consent to
p.(None): participate in a clinical investigation can be withdrawn at any time without negative consequences for the person.
p.(None): (4) Clinical investigation of partially capable majors shall be carried out after they and their legal
p.(None): representative have expressed written informed consent. A partially capable person shall be provided with
p.(None): information under para 1, item 1 according to his/her capacity of understanding. The explicit wish of
p.(None): the person to be withdrawn at any time is considered by the investigator or, where appropriate, by the
p.(None): principal investigator.
p.(None): (5) Informed consent of an incapable major person shall be given by his/her legal
p.(None): representative.
p.(None): (6) In cases referred to in Art. 162, para 3 of the Health Act, informed consent shall be given by a person assigned by
p.(None): the court.
p.(None):
p.(None):
p.(None): Art. 38. (1) A clinical trial on a minor person shall be carried out after obtaining written informed
p.(None): consent by his/her legal representatives - both subject’s parents or the guardian pursuant to Art. 37, para
p.(None): 1, item 1 and 2 and para 3. Where one of the parents is unknown, deceased, or deprived of parental rights or such
p.(None): rights have not been delegated in case of divorce, written informed consent shall be given by the parent who exercises
p.(None): parental rights.
p.(None): (2) A clinical trial on an underage person shall be conducted after obtaining written informed
p.(None):
p.(None): consent by the subject and his/her legal representatives - both subject’s parents or the guardian
p.(None): according to Art. 37, para 1, item 1 and 2 and para 3. Where one of the parents is unknown, deceased, or deprived of
p.(None): parental rights or such rights have not been delegated in case of divorce, written informed consent shall be expressed
p.(None): by the parent who is exercising parental rights.
p.(None): (3) Minors or underage persons shall be provided with information about the nature,
p.(None): significance, consequences and eventual risks and benefits of the clinical trial in a manner
p.(None): understandable for that person by a paediatrician or children’s psychologist.
p.(None): (4) The consent of the parents or the guardian must represent the minor's presumed will and may be revoked at any
p.(None): time, without detriment to the minor and/or to them.
p.(None): (5) The consent of an underage person, his/her parents and guardian can be withdrawn at any time without negative
p.(None): consequences for them.
p.(None):
p.(None):
p.(None): Art. 39. Where it is not possible to take urgent informed consent by the parent(s) or respectively by the guardian and
p.(None): the direct purpose to save the life of a minor, underage person, incapable or partially capable major, the decision to
p.(None): take part in a clinical investigation of any of the said persons shall be taken by at least two doctors, independent
p.(None): from the assignor and from the principal and coordinating investigator.
p.(None):
p.(None):
p.(None): Art. 40. (1) Clinical trials on pregnant women can be conducted according to the requirements as per Art. 37 only in
p.(None): those cases where there are no other alternative diagnostics or treatment methods and if it does not threaten the
p.(None): pregnant woman’s life and health and the fetus vitality.
p.(None): (2) Decision for involvement in a clinical investigation in the cases referred to in para 1 shall be taken by a
p.(None): committee of physicians, independent from the assignor and the principal and coordinating investigator.
p.(None):
p.(None):
p.(None): Art. 41. (1) Subjects shall be provided with further information throughout the clinical investigation by a
p.(None): person independent from the assignor upon request.
p.(None): (2) The written information provided to the subject during the clinical trial contains contact data of the independent
p.(None): person under para 1.
p.(None):
p.(None):
p.(None): Art. 42. (1) In those cases where an assignor who is not established on the territory of EU or on the territory of a
p.(None): state from the European Economic Area carries out one-site or multi-centre clinical trial on the territory of the
p.(None): Republic of Bulgaria, the latter shall authorize his/her representative established on the Republic of Bulgaria.
...
Health / Physically Disabled
Searching for indicator illness:
(return to top)
p.(None): a) is responsible for the design, manufacture, packaging and labelling of a device before it is
p.(None):
p.(None): placed on the market under his own name, regardless of whether these operations are carried out by that person himself
p.(None): or on his behalf by a third party;
p.(None): b) (amend. – SG 11/08) assembles, packages, processes, fully refurbishes and/or labels one or more ready-made products
p.(None): and/or assigns to them their intended purpose as devices with a view to their being placed on the market under his own
p.(None): name.
p.(None): Natural or legal persons who assembles or adapts devices already on the market to their intended purpose
p.(None): for an individual patient shall not be considered manufacturers within the meaning of this Act.
p.(None): 31. "Putting into service" means the stage at which a device has been made available to the final user as
p.(None): being ready for use in a Member State or a state from the European Economic Area for the first time for its intended
p.(None): purpose. of An active implantable medical device shall be considered put into service when made available to a
p.(None): qualified expert for implanting.
p.(None): 32. "Placing on the market" means the first making available in return for payment or free of charge of a device, other
p.(None): than a medical device for clinical trial and a device intended for performance evaluation, with a view to distribution
p.(None): and/or use on the territory of the European Union or the European Economic Area, regardless of whether it is new or
p.(None): fully refurbished.
p.(None): 33. "Serious health damage" means:
p.(None): 1. life-threatening condition, illness or harm;
p.(None): 2. lasting harm to the life functions or to a human organ or tissue;
p.(None): 3. a condition which requires medical or surgical intervention in order to prevent the damages under item 2;
p.(None): 34. "Human specimen receptacles" are those devices, whether vacuum-type or not, specifically intended by their
p.(None): manufacturers for the primary containment and preservation of specimens derived from the human body for the
p.(None): purpose of in vitro diagnostic examination.
p.(None): 35. "Essential amendment in the clinical trial plan" means any amendment in the plan and/or the information contained
p.(None): in the documentation that goes along with it, which affects:
p.(None): a) the safety or the physical and mental integrity of the persons involved; b) the scientific value of the
p.(None): investigation;
p.(None): c) the conducting or organization of the trial.
p.(None): 35a. (new - SG 38/15, in force from 26.05.2015) "Third country" shall mean any which is not an EU member or not a
p.(None): state - party to the Agreement on the European Economic Area or Swiss Confederation.
p.(None): 36. (amend. – SG 54/12) "Retail trade" are all activities related to acquisition, storage and sale of medical devices
p.(None): to the population.
p.(None): 37. (amend. – SG 54/12) "Wholesale trade" are all activities related to acquisition, storage, supply,
p.(None): import or export of medical devices intended for sale, except the cases of providing medical devices
p.(None): directly to the population.
p.(None): 38. (amend. – SG 110/08) "Authorised representative" means any natural or legal person established on the
...
Health / Pregnant
Searching for indicator pregnant:
(return to top)
p.(None): (3) Minors or underage persons shall be provided with information about the nature,
p.(None): significance, consequences and eventual risks and benefits of the clinical trial in a manner
p.(None): understandable for that person by a paediatrician or children’s psychologist.
p.(None): (4) The consent of the parents or the guardian must represent the minor's presumed will and may be revoked at any
p.(None): time, without detriment to the minor and/or to them.
p.(None): (5) The consent of an underage person, his/her parents and guardian can be withdrawn at any time without negative
p.(None): consequences for them.
p.(None):
p.(None):
p.(None): Art. 39. Where it is not possible to take urgent informed consent by the parent(s) or respectively by the guardian and
p.(None): the direct purpose to save the life of a minor, underage person, incapable or partially capable major, the decision to
p.(None): take part in a clinical investigation of any of the said persons shall be taken by at least two doctors, independent
p.(None): from the assignor and from the principal and coordinating investigator.
p.(None):
p.(None):
p.(None): Art. 40. (1) Clinical trials on pregnant women can be conducted according to the requirements as per Art. 37 only in
p.(None): those cases where there are no other alternative diagnostics or treatment methods and if it does not threaten the
p.(None): pregnant woman’s life and health and the fetus vitality.
p.(None): (2) Decision for involvement in a clinical investigation in the cases referred to in para 1 shall be taken by a
p.(None): committee of physicians, independent from the assignor and the principal and coordinating investigator.
p.(None):
p.(None):
p.(None): Art. 41. (1) Subjects shall be provided with further information throughout the clinical investigation by a
p.(None): person independent from the assignor upon request.
p.(None): (2) The written information provided to the subject during the clinical trial contains contact data of the independent
p.(None): person under para 1.
p.(None):
p.(None):
p.(None): Art. 42. (1) In those cases where an assignor who is not established on the territory of EU or on the territory of a
p.(None): state from the European Economic Area carries out one-site or multi-centre clinical trial on the territory of the
p.(None): Republic of Bulgaria, the latter shall authorize his/her representative established on the Republic of Bulgaria.
p.(None): (2) (amend. – SG 110/08, in force from 21.03.2010) In those cases where an assignor who is not established on the
p.(None): territory of the Republic of Bulgaria and on the territory of another Member State(s) and/or on the
p.(None): territory of a state/states from the European Economic Area and/or on the territory of a third country, he/she shall
p.(None): authorize a representative established on the territory of a state from EU or European Economic Area.
p.(None): (3) The authorized representative under para 1 and para 2 bears the responsibility for conducting
p.(None): clinical trials on the territory of the Republic of Bulgaria according to the legislation in force.
...
Social / Child
Searching for indicator children:
(return to top)
p.(None): consent by his/her legal representatives - both subject’s parents or the guardian pursuant to Art. 37, para
p.(None): 1, item 1 and 2 and para 3. Where one of the parents is unknown, deceased, or deprived of parental rights or such
p.(None): rights have not been delegated in case of divorce, written informed consent shall be given by the parent who exercises
p.(None): parental rights.
p.(None): (2) A clinical trial on an underage person shall be conducted after obtaining written informed
p.(None):
p.(None): consent by the subject and his/her legal representatives - both subject’s parents or the guardian
p.(None): according to Art. 37, para 1, item 1 and 2 and para 3. Where one of the parents is unknown, deceased, or deprived of
p.(None): parental rights or such rights have not been delegated in case of divorce, written informed consent shall be expressed
p.(None): by the parent who is exercising parental rights.
p.(None): (3) Minors or underage persons shall be provided with information about the nature,
p.(None): significance, consequences and eventual risks and benefits of the clinical trial in a manner
p.(None): understandable for that person by a paediatrician or children’s psychologist.
p.(None): (4) The consent of the parents or the guardian must represent the minor's presumed will and may be revoked at any
p.(None): time, without detriment to the minor and/or to them.
p.(None): (5) The consent of an underage person, his/her parents and guardian can be withdrawn at any time without negative
p.(None): consequences for them.
p.(None):
p.(None):
p.(None): Art. 39. Where it is not possible to take urgent informed consent by the parent(s) or respectively by the guardian and
p.(None): the direct purpose to save the life of a minor, underage person, incapable or partially capable major, the decision to
p.(None): take part in a clinical investigation of any of the said persons shall be taken by at least two doctors, independent
p.(None): from the assignor and from the principal and coordinating investigator.
p.(None):
p.(None):
p.(None): Art. 40. (1) Clinical trials on pregnant women can be conducted according to the requirements as per Art. 37 only in
p.(None): those cases where there are no other alternative diagnostics or treatment methods and if it does not threaten the
...
Social / Fetus/Neonate
Searching for indicator fetus:
(return to top)
p.(None): time, without detriment to the minor and/or to them.
p.(None): (5) The consent of an underage person, his/her parents and guardian can be withdrawn at any time without negative
p.(None): consequences for them.
p.(None):
p.(None):
p.(None): Art. 39. Where it is not possible to take urgent informed consent by the parent(s) or respectively by the guardian and
p.(None): the direct purpose to save the life of a minor, underage person, incapable or partially capable major, the decision to
p.(None): take part in a clinical investigation of any of the said persons shall be taken by at least two doctors, independent
p.(None): from the assignor and from the principal and coordinating investigator.
p.(None):
p.(None):
p.(None): Art. 40. (1) Clinical trials on pregnant women can be conducted according to the requirements as per Art. 37 only in
p.(None): those cases where there are no other alternative diagnostics or treatment methods and if it does not threaten the
p.(None): pregnant woman’s life and health and the fetus vitality.
p.(None): (2) Decision for involvement in a clinical investigation in the cases referred to in para 1 shall be taken by a
p.(None): committee of physicians, independent from the assignor and the principal and coordinating investigator.
p.(None):
p.(None):
p.(None): Art. 41. (1) Subjects shall be provided with further information throughout the clinical investigation by a
p.(None): person independent from the assignor upon request.
p.(None): (2) The written information provided to the subject during the clinical trial contains contact data of the independent
p.(None): person under para 1.
p.(None):
p.(None):
p.(None): Art. 42. (1) In those cases where an assignor who is not established on the territory of EU or on the territory of a
p.(None): state from the European Economic Area carries out one-site or multi-centre clinical trial on the territory of the
p.(None): Republic of Bulgaria, the latter shall authorize his/her representative established on the Republic of Bulgaria.
p.(None): (2) (amend. – SG 110/08, in force from 21.03.2010) In those cases where an assignor who is not established on the
p.(None): territory of the Republic of Bulgaria and on the territory of another Member State(s) and/or on the
p.(None): territory of a state/states from the European Economic Area and/or on the territory of a third country, he/she shall
p.(None): authorize a representative established on the territory of a state from EU or European Economic Area.
p.(None): (3) The authorized representative under para 1 and para 2 bears the responsibility for conducting
p.(None): clinical trials on the territory of the Republic of Bulgaria according to the legislation in force.
p.(None): (4) (revoked – SG 110/08, in force from 21.03.2010). (5) (revoked – SG 110/08, in force from 21.03.2010). (6) (revoked
p.(None): – SG 110/08, in force from 21.03.2010).
p.(None):
...
Social / Incarcerated
Searching for indicator restricted:
(return to top)
p.(None): Placing on the market of systems or sets of medical devices
p.(None):
p.(None): Art. 21. (1) A natural or legal person who makes into sets medical devices referred to in Art. 2, para.1, item 3 with
p.(None): CE marking shall, prior to placing them on the market as a system or set, prepare a declaration stating that:
p.(None): 1. they have completed the system or set according to the purpose of the separate devices and the restrictions on their
p.(None): use determined by the manufacturers;
p.(None): 2. they have checked the conformity of the individual medical devices and have carried out the assembling procedures
p.(None): according to the instructions of manufacturers;
p.(None): 3. they have packed the system or set and they have provided the users with the necessary information
p.(None): including the respective manufacturers’ instructions;
p.(None): 4. their activity is subject to internal control and surveillance procedures.
p.(None): (2) In case any of the requirements of para.1 has not been met, the system or set shall be subject to conformity
p.(None): assessment regarding the essential requirements set out in the ordinances as per Art. 18.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Art. 21
p.(None): Art. 22. (1) A natural or legal person who sterilizes systems or sets of medical devices as per and/or medical
p.(None): devices referred to in Art. 2, para.1, item 3 with CE marking, which
p.(None): manufacturers have intended for sterilization before use, must assess their conformity by way of
p.(None): procedures set out in the respective ordinance as per Art.18.
p.(None): (2) (suppl. – SG 110/08) The implementation of the procedures set out in para.1 and the actions of the notified
p.(None): authority shall be restricted to meeting the sterility requirements up to the time of
p.(None):
p.(None): damaging of the integrity of device package.
p.(None): (3) The person referred to in para.1 shall draw up a declaration in accordance with the requirements set
p.(None): out in the respective ordinance, stating that sterilization has been carried out according to the manufacturers’
p.(None): instructions.
p.(None):
p.(None):
p.(None): Art. 23. (amend. – SG 110/08) The persons under Art. 21, para.1 and Art. 22, para.1 shall keep the declarations for
p.(None): a period of 5 years and shall present them to the persons referred to in Art. 86, para.2, upon request,
p.(None): in order to be reviewed.
p.(None):
p.(None):
p.(None): Art. 24. The systems or sets of medical devices under Art. 21, the sterilized systems or sets and the medical devices
p.(None): as per Art. 2, para.1, item 3 with CE marking, intended by the manufacturer for sterilization before use, shall
p.(None): be placed on the market without additional CE marking and shall be accompanied by instructions for use
p.(None): containing, where necessary, the information provided by the manufacturer of the individual devices in the
p.(None): system or set, the requirements for which are determined in the respective ordinance as per Art. 18.
p.(None):
p.(None):
p.(None): Section V.
p.(None): Performance evaluation of in-vitro diagnostic medical devices
p.(None):
p.(None): Art. 25. (1) The conformity assessment of in-vitro diagnostic medical devices regarding their specific purpose under
p.(None): conditions of use specified by the manufacturer shall be carried out by way of performance evaluation on the grounds
p.(None): of:
p.(None): 1. collective data from scientific literature relating to the purpose of the device, and a critical analysis of this
p.(None): data, and/or
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.(None): ordinance under Art. 21e, Para. 1 of the Act on Protection against the Harmful Impact Of Chemical
p.(None): Substances And Mixtures, subject to CE marking, the marking certifies the compliance of the device with the
p.(None): requirements of each of the ordinances, unless otherwise
p.(None):
p.(None): stipulated therein.
p.(None): (10) At exhibitions, trade fairs, demonstrations, promotions, scientific and technical conferences
p.(None): can be presented medical devices without affixed CE marking.
p.(None): (11) In the cases referred to in para.10 manufacturers shall place a visible sign clearly indicating that
p.(None): such devices are not intended for placing on the market and/or putting into service.
p.(None):
p.(None):
p.(None): Art. 16 (1) Manufacturers of medical devices shall be obliged to specify their name,
p.(None): headquarters and business address on the device, its packing and instructions for use. Instruction for use is not
p.(None): required for devices under Art.2, para.1, item 3 from class I and IIa which, in the manufacturer’s opinion can be used
p.(None): safely without instructions for use.
p.(None): (2) The name and address of the authorized representative and of the importer are additionally specified on the
p.(None): packing and in the instructions for use of devices which are imported from third countries on the
p.(None): territory of the European Union or on the territory of the European Economic Area.
p.(None): (3) The instruction for use shall also be written in Bulgarian language.
p.(None):
p.(None):
p.(None): Art. 17. Manufacturers or their authorized representatives shall be obliged to ensure that medical devices
p.(None): are installed in a safe manner on the territory of the Republic of Bulgaria, where necessary due to
p.(None): their specific character according to the instruction for use, and to guarantee their maintenance.
p.(None):
p.(None):
p.(None): Art. 18. (amend. – SG 82/09, in force from 16.10.2009; amend. – SG, 14/15) Upon proposal by the Minister of Health and
p.(None): the Minister of Economy, the Council of Ministers shall determine by way of ordinance the following issues concerning
p.(None): medical devices referred to in Art.2. para.1:
p.(None): 1. essential requirements;
p.(None): 2. assessment conformity procedures regarding the essential requirements and the contents of the technical
p.(None): documentation;
p.(None): 3. rules for classification of medical devices referred to in Art.2, para.1, item 3; 4. the lists specifying the scope
p.(None): of groups of in-vitro diagnostic medical devices;
p.(None): 5. requirements for carrying out risk analysis and management with regards to medical devices as per Art.11, para.5.
p.(None):
p.(None):
p.(None): Section III.
p.(None): Putting on the market and/or putting into service of custom-made medical devices
p.(None):
p.(None): Art. 19. (1) (amend. – SG 110/08, in force from 21.03.2010) Prior to placing on the market and/or
p.(None): putting into service of a custom-made medical device under Art.2, para.1, item 2 or 3, the manufacturer
p.(None): or their authorized representative shall prepare documentation containing:
p.(None): 1. the manufacturer’s name and address; 2. device identification data;
...
p.(None): device;
p.(None): 3. document certifying paid fee to the amount fixed in the tariff as per Art. 7, para 1.
p.(None): (3) (amend. – SG 110/08, in force from 21.03.2010) The persons referred to in para 1 are obliged to
p.(None): notify the Executive Director of BDA of any change in their headquarters address within 14 days. In case of change in
p.(None): the information under para 2, item 2, the bodies under para 1 shall submit an application as per para 1 to the
p.(None): Executive Director of BDA, with documents concerning the change attached to it and a document certifying paid
p.(None): fee to the amount fixed in the tariff as per Art. 7, para 1.
p.(None):
p.(None):
p.(None): Art. 28. (1) Where a manufacturer of devices referred to in Art. 2, para 1, item 1 places on the market and/or puts
p.(None): into service the said devices on the territory of the Republic of Bulgaria and is registered under the
p.(None): Commerce Act, he/she shall submit an application for registration to the Executive Director of BDA.
p.(None): (2) The following documents shall be attached to the registration form under para 1:
p.(None): 1. (amend. - SG 60/11, in force from 05.08.2011) a unified identity code of the company;
p.(None): 2. information relating to the reagents, reagent products and calibration and control materials in terms of common
p.(None): technological and/or analytical characteristics;
p.(None): 3. in case of devices from list A, list B and self-testing devices - name, type and model of the device, analytical
p.(None): and, if necessary, diagnostic features according to the essential requirements indicated in regulations under Art.18,
p.(None): results of in-vitro medical device performance evaluation.
p.(None): 4. instruction for use in Bulgarian language;
p.(None): 5. document for paid fee in amount fixed by the tariff as per Art. 7, para 1.
p.(None): (3) (amend. – SG 110/08) Manufacturers who place on the market and/or put into service a new in-vitro diagnostic
p.(None): medical device within the territory of the Republic of Bulgaria, in case he/they are registered under the Commerce Act,
p.(None): shall submit to BDA the documents set out in para 2 as well as indication that the device is new.
p.(None): (4) (amend. – SG 110/08) An in-vitro diagnostic medical device is new if on the market of a Member State or a state
p.(None): from the European Economic Area during the last three years:
p.(None): 1. there has been no such device continuously available for the relevant analyte or other parameter, or
p.(None): 2. the analytical technology used in connection with a given analyte or other parameter has not been available.
p.(None): (5) (revoked – SG 110/08, in force from 21.03.2010).
p.(None): (6) (amend. – SG 110/08, in force from 21.03.2010) The application form for registration under
p.(None):
p.(None): paras 1 and 3 shall be submitted within 14 days from the date of placing on the market and/or putting into service of
p.(None): devices referred to in Art. 2, para 1, item 1.
p.(None): (7) (amend. – SG 110/08, in force from 21.03.2010) The persons referred to in paras 1 and 3 are obliged to notify
p.(None): within 14 days the Executive Director of BDA in case of:
p.(None): 1. change in the headquarters address;
p.(None): 2. significant changes in the information as per para 2, items 2 and 3; 3. (revoked – SG 110/08, in force from
p.(None): 21.03.2010);
p.(None): 4. withdrawal of the device from the market.
p.(None):
p.(None):
p.(None): Art. 29. (amend. – SG 110/08, in force from 21.03.2010) (1) In cases of Art. 10, par. 2 where the authorized
...
p.(None): Council of 20 July 1990 on the approximation of the legislation of Member States relating to active implantable
p.(None): medical devices, last amended with Directive 2007/47/EC of the European Parliament and of the Council of 5
p.(None): September 2007 amending the Directive 90/385/EEC of the Council on the approximation of the legislation of
p.(None): Member States relating to active implantable
p.(None):
p.(None): medical devices, of Directive 93/42/EEC of the Council concerning the medical devices and of Directive 98/8/EC
p.(None): concerning the placing on the market of biocidal products (OJ, L 247/21 of 21 September 2007), of
p.(None): Directive 93/42/EEC of the Council of 14 June 1993 of medical devices, last amended by Directive
p.(None): 2007/47/EC of the European Parliament and of the Council and of Directive 98/79/EC of the European Parliament and of
p.(None): the Council of 27 October 1998 on in vitro diagnostic medical devices, last amended by Regulation (EC) No.
p.(None): 1882/2003 of the European Parliament and of the Council of 29 September 2003 adapting to the Council Decision
p.(None): 1999/468/EC the provisions relating to committees which assist the Commission in the exercise of its
p.(None): implementing powers laid down in instruments subject to the procedure referred to in Art. 251 of the EC Treaty.
p.(None):
p.(None):
p.(None): § 3. (1) Names and registration numbers of harmonized European standards and the monographs of
p.(None): the European pharmacopoeia for medical devices are published in the Official Journal of EU.
p.(None): (2) Harmonized European Standards are introduced identically through publishing the text of the standard in Bulgarian
p.(None): language or confirming their application as a Bulgarian Standard pursuant to the National Standardisation Act.
p.(None): (3) Names and registration numbers of the Bulgarian standards introducing the harmonized European standards
p.(None): are published in the official bulletin of the State Agency for Metrology and Technical Surveillance and
p.(None): upon publishing it is obligatory that reference to the relevant regulation under Art. 18 is indicated.
p.(None):
p.(None):
p.(None): § 4. (1) The general technical specifications determine the requirements for assessment and re-assessment
p.(None): of service, placing on the market and/or putting into service of batches, referent methods and referent materials
p.(None): regarding in-vitro diagnostic medical devices.
p.(None): (2) The general technical specifications are published in the Official Journal of the EU.
p.(None):
p.(None):
p.(None): § 4a. (new - SG 38/15, in force from 26.05.2015) The Executive Director of BDA may delegate his or her powers under
p.(None): this Act to the Deputy Executive Director of BDA.
p.(None):
p.(None): Transitional and concluding provisions
p.(None):
p.(None):
p.(None): § 5. (1) Traders, who have been authorized to carry out wholesale trade in medicines - medical devices, the
p.(None): authorization being issued after December 29, 2002 pursuant to the repealed Act on Medicines and Pharmacies
p.(None): in Human Medicine, shall, within three months from the entry into force of the Act, submit an application form for
p.(None): entry ex officio in the register as per Art. 81, to which shall be attached the documents under Art. 78, para 1, items
p.(None): 1 and 2, para 2, items 3 and 4, as well as a statement that there is a change in the address of the storage and trade
p.(None): premises.
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.(None): Act, introducing Directive EU 2006/42 of the European Parliament and of the Council of 17 May 2007 regarding the
p.(None): machines and amending the Directive 95/16/EC and there is a risk of its application, the relevant essential safety
p.(None): requirements set out in it shall apply to it, provided that these requirements are more specific than the ones provided
p.(None): for in the ordinance as per Art.18.
p.(None): (3) (new – SG, 84/2012, in force from 02.01.2013) Where a medical device under Art. 2, Para. 1, p. 1 and 3 falls in the
p.(None): application scope of Chapter Five “a” of the Act on Protection of the Dangerous Impact of Chemical Substances and
p.(None): Mixtures, to it shall apply also the requirements for restriction of the use of dangerous substances, determined by the
p.(None): ordinance under Art. 21e, Para. 1 of the same act.
p.(None): (4) (new – SG, 84/2012, in force from 02.01.2013) The requirements of Para. 3 shall apply also to cable or spare parts
p.(None): for the repair for second use, of updating of the characteristics or for raising the capacity of this device.
p.(None):
p.(None):
p.(None): Art. 5. (1) This Act shall not apply to:
p.(None): 1. (suppl. – SG 110/08) medicinal products under the Medicinal Products in Human Medicine Act. The assessment whether a
p.(None): particular product falls within the scope of application of this Act or in the scope of application of the Medicinal
p.(None): Products in Human Medicine Act shall be carried out on the grounds of the product main purpose of use;
p.(None):
p.(None): 2. medical devices which are an integral part of medicinal products and are intended for single use only in this form
p.(None): by the manufacturer;
p.(None): 3. cosmetic products under the Health Act;
p.(None): 4. (suppl. – SG 110/08) organs, tissues and cells of human origin intended for transplantation,
p.(None): as well as products containing or obtained from tissues and cells of human origin under the
p.(None): Transplantation of Organs, Tissues, and Cells Act, except for the medical devices under Art. 3, item 3;
p.(None): 5. organs, tissues and cells of animal origin intended for transplantation, unless a device is
p.(None): manufactured utilizing animal tissue which is rendered non-viable or non-viable products derived from animal tissue;
p.(None): 6. blood, blood ingredients of human origin within the meaning of the Blood, as well as devices which incorporate at
p.(None): the time of placing on the market such blood products, plasma or cells, except for medical devices under Art.3, item 3;
p.(None): 7. medical devices under Art.2, para.1, item 1 which are not intended for placing on the market, which are used at the
p.(None): production site and, if used at sites in the immediate vicinity, the ownership on them is not transferred to another
p.(None): legal entity.
p.(None): (2) In the cases referred to in para.1, item 2 the device must meet the requirements of the Medicinal
p.(None): Products in Human Medicine Act. The essential requirements provided for by this Act shall be applied only with regards
p.(None): to the particular features referring to the safe operation of the device.
p.(None):
p.(None):
p.(None): Art. 6. While exercising its powers under this Act, BDA shall:
p.(None): 1. (amend. – SG 110/08) arrange registration under the terms and procedures of Chapter II;
p.(None): 2. (new - SG 38/15, in force from 26.05.2015) issue conformity assessment authorizations for medical devices under
p.(None): Chapter Four;
...
p.(None): 10. (prev. text of item 9 - SG 38/15, in force from 26.05.2015) take part in actions in the medical
p.(None): devices field related to the activity of international authorities, organizations and agreements to which the
p.(None): Republic of Bulgaria is a party, together with the regulatory and control bodies of other countries and
p.(None): the organizations carrying out activity in the sphere of medical devices regulation;
p.(None): 11. (amend. – SG 110/08; prev. text of item 10, suppl. - SG 38/15, in force from 26.05.2015) create and keep the
p.(None): registers under Art. 31, par. 2, Art. 58, par. 1, Art. 67, para 1 and Art. 81;
p.(None): 12. (prev. text of item 11 - SG 38/15, in force from 26.05.2015) carry out other activities specified
p.(None): in this Act.
p.(None):
p.(None):
p.(None): Art. 6a (new – SG 110/08, in force from 21.03.2010) The Bulgarian Drug Agency shall draw
p.(None):
p.(None): up a justified request to the European Commission for undertaking necessary measures, whenever it
p.(None): considers, that:
p.(None): 1. the application of the classification rules of Art. 2, par. 3 requires taking a decision for
p.(None): classification of a particular medical device or category of devices of Art. 2, par. 1, item 3;
p.(None): 2. a particular medical device or a group of devices of Art. 2, par. 1, item 3, regardless the
p.(None): classification rules of Art. 2, par. 3 may be classified under a different class of devices;
p.(None): 3. the conformity of a particular medical device or of a group of devices of Art. 2, par. 1, item 2 or 3 must be
p.(None): assessed by applying only one single procedure provided in the ordinances of Art. 18;
p.(None): 4. taking a decision is necessary, whether a particular product or a group of products falls into the scope of
p.(None): application of this Act.
p.(None):
p.(None):
p.(None): Art. 7. (1) For the purpose of registration and issue of registration certificates, issue of
p.(None): authorization and certificates according to this Act, as well as for entering amendments therein, shall be paid fees
p.(None): the amount of which is specified in a tariff, approved by the Council of Ministers.
p.(None): (2) (amend. - SG 38/15, in force from 26.05.2015) The amounts of fees under para.1 and of fines and property
p.(None): sanctions enforced on natural and legal persons according to this Act shall be deposited as budget revenue
p.(None): of BDA.
p.(None):
p.(None):
p.(None): Section II.
p.(None): Placing on the market and/or putting into service of medical devices
p.(None):
p.(None): Art. 8. (1) Medical devices shall be released on the market and/or put into service provided that they meet the
p.(None): requirements of this Act and the acts relating to its implementation.
p.(None): (2) Medical devices, except for custom-made ones, shall be placed on the market and/or put into service if they bear
p.(None): the CE marking under Art.15 certifying that the compliance of the devices with the essential requirements has been
p.(None): assessed by means of the applicable conformity assessment procedures.
p.(None):
p.(None):
p.(None): Art. 9. (1) The Executive Director of BDA shall issue an order for temporary suspension or prohibition of
p.(None): placing on the market and/or putting into service and for withdrawal from the market of medical devices with CE marking
...
p.(None): metabolic means, but which may be assisted in its function by such means and which is intended by the
p.(None): manufacturer to be used for human beings for the purpose of:
p.(None): a) diagnosis, prevention, monitoring, treatment or alleviation of diseases;
p.(None): b) diagnosis, monitoring, treatment, alleviation or compensation of trauma or disability;
p.(None): c) investigation, replacement or modification of the anatomy or of a physiological process; d) control of conception
p.(None): process.
p.(None): 22. (amend. – SG 110/08, in force from 21.03.2010) "Device intended for clinical testing" means any
p.(None): medical device referred to in Art. 2, para 1, items 2 and 3, intended to be used by a medical specialist of by another
p.(None): specialist, having relevant for the testing purposes qualification, for conducting clinical testing in the medical
p.(None): establishment in order to achieve the objective referred to in Art. 32.
p.(None): 23. (amend. – SG 110/08) "Custom-made device" е means any medical device referred to in Art. 2, para 1, items 2 or 3,
p.(None): specifically made in accordance with a written prescription by a medical expert or a person with relevant
p.(None): professional qualification, which gives, under his/her responsibility, specific design characteristics of the
p.(None): device and is intended to be used only for an individual named patient.
p.(None): Mass-produced devices, adapted in order to meet the specific requirements of the medical practitioner or of
p.(None): any other trained user are not considered to be custom-made devices.
p.(None): 24. "Multi-centre clinical trial" means a clinical trial conducted according to a single trial plan but at more than
p.(None): one investigation centre/medical establishment, and therefore by more than one investigator. The
p.(None): investigation centres may be located in the territory of a single Member State, in a number of Member States
p.(None): and/or in Member States and third countries;
p.(None): 25. "Observer" means a person, appointed by the assignor, monitoring whether the clinical investigation at
p.(None): each of its stages is being conducted, recorded and reported according to the protocol, the standard operative
p.(None): procedures, the Good Clinical Practice an the applicable control requirements.
p.(None): 26. "A person independent from the assignor" is a natural person acquainted with the characteristics and
p.(None): the operation of the medical device – subject to a clinical investigation, and with the methodology of conducting such,
p.(None): and who is financially independent from the assignor.
p.(None): 27. "Clinical trial plan" is a document providing information on the purposes, design, methodology,
p.(None): statistical methods and organization of a clinical investigation.
p.(None): 28. "Intended purpose" means the use for which a medical device has been designated according to the
p.(None): data provided by the manufacturer on its label, the instructions for use and/or the advertisement notices.
p.(None): 29. "Accessory" means an Art. which, whilst not being a medical device, is intended specifically by its
p.(None): manufacturer to be used together with a device to enable that device to be used in accordance with its intended
p.(None): purpose.
p.(None): For the purposes of this definition, invasive sampling devices or those which are directly applied to
p.(None): the human body for the purpose of obtaining a specimen within the meaning of Directive 93/42/EEC shall not
p.(None): be considered to be accessories to in vitro diagnostic medical devices;
p.(None): 30. "Manufacturer" means the natural or legal person who:
...
Social / Property Ownership
Searching for indicator home:
(return to top)
p.(None): 6. "Principal investigator" is the leader of the investigation team, carrying out clinical trial.
p.(None): 7. "Good clinical practice" means the entirety of internationally acknowledged ethical and scientific
p.(None): quality requirements which are to be met when planning, conducting, accounting and reporting of clinical trials.
p.(None): 8. "Member State" means a Member State of the European. 9. "Data allowing identification of the device" includes:
p.(None): a) information about the manufacturer, model and type number of the device, including software and
p.(None): appliances;
p.(None): b) intended use determined by the manufacturer, including clinical indications and
p.(None): contraindications during use and identification of the groups of patients for whom it has been
p.(None): designated;
p.(None): c) description of the device – description of materials that come into contact with human tissues or liquids, whether
p.(None): the devices comprises a medicinal product, human and/or animal tissues or derivatives, or biologically
p.(None): active substances;
p.(None): d) instructions for installation and use of the device, in case there are any special terms of
p.(None): preservation or function requirements – preliminary preparation before use – sterilization in cases of
p.(None): repeated use, safety check, measures that should be undertaken before use;
p.(None): e) recommended training and experience required for use of the device;
p.(None): f) description of the required medical and surgical procedures related to the use of the device;
p.(None): 10. "Device for self-testing" means any in-vitro diagnostic medical device intended by the manufacturer to
p.(None): be able to be used by lay persons in a home environment.
p.(None): 11. "Invasive medical device for continuous use" means any active medical device which is intended to be
p.(None): totally or partially introduced to the human body through a natural orifice or it surface, and which is intended to
p.(None): remain for more than 30 days.
p.(None): 12. "In-vitro diagnostic medical device" means any medical device which is a reagent, reagent product, calibrator,
p.(None): control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination,
p.(None): intended by the manufacturer to be used in vitro for the examination of specimens, including blood and
p.(None): tissue donations, derived from the human body, solely or principally for the purpose of providing information:
p.(None): a) concerning a physiological or pathological state, or b) concerning a congenital abnormality, or
p.(None): c) to determine the safety and compatibility with potential recipients, or d) to monitor therapeutic measures.
p.(None): In vitro diagnostic medical devices are also considered to be the devices for self-testing, specimen
p.(None): receptacles, except for the products for general laboratory use unless such products, in view of their
p.(None): characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic
p.(None): examinations.
p.(None): 13. "In vitro diagnostic device for performance evaluation" means any in vitro diagnostic device intended
p.(None): by the manufacturer to be subject to one or more performance evaluation studies in
p.(None):
p.(None): laboratories for medical analyses or in other appropriate environments outside production premises;
...
Searching for indicator property:
(return to top)
p.(None): 12. (prev. text of item 11 - SG 38/15, in force from 26.05.2015) carry out other activities specified
p.(None): in this Act.
p.(None):
p.(None):
p.(None): Art. 6a (new – SG 110/08, in force from 21.03.2010) The Bulgarian Drug Agency shall draw
p.(None):
p.(None): up a justified request to the European Commission for undertaking necessary measures, whenever it
p.(None): considers, that:
p.(None): 1. the application of the classification rules of Art. 2, par. 3 requires taking a decision for
p.(None): classification of a particular medical device or category of devices of Art. 2, par. 1, item 3;
p.(None): 2. a particular medical device or a group of devices of Art. 2, par. 1, item 3, regardless the
p.(None): classification rules of Art. 2, par. 3 may be classified under a different class of devices;
p.(None): 3. the conformity of a particular medical device or of a group of devices of Art. 2, par. 1, item 2 or 3 must be
p.(None): assessed by applying only one single procedure provided in the ordinances of Art. 18;
p.(None): 4. taking a decision is necessary, whether a particular product or a group of products falls into the scope of
p.(None): application of this Act.
p.(None):
p.(None):
p.(None): Art. 7. (1) For the purpose of registration and issue of registration certificates, issue of
p.(None): authorization and certificates according to this Act, as well as for entering amendments therein, shall be paid fees
p.(None): the amount of which is specified in a tariff, approved by the Council of Ministers.
p.(None): (2) (amend. - SG 38/15, in force from 26.05.2015) The amounts of fees under para.1 and of fines and property
p.(None): sanctions enforced on natural and legal persons according to this Act shall be deposited as budget revenue
p.(None): of BDA.
p.(None):
p.(None):
p.(None): Section II.
p.(None): Placing on the market and/or putting into service of medical devices
p.(None):
p.(None): Art. 8. (1) Medical devices shall be released on the market and/or put into service provided that they meet the
p.(None): requirements of this Act and the acts relating to its implementation.
p.(None): (2) Medical devices, except for custom-made ones, shall be placed on the market and/or put into service if they bear
p.(None): the CE marking under Art.15 certifying that the compliance of the devices with the essential requirements has been
p.(None): assessed by means of the applicable conformity assessment procedures.
p.(None):
p.(None):
p.(None): Art. 9. (1) The Executive Director of BDA shall issue an order for temporary suspension or prohibition of
p.(None): placing on the market and/or putting into service and for withdrawal from the market of medical devices with CE marking
p.(None): as per Art.15, as well as of custom-made devices, which can threaten the health and safety of patients, medical
p.(None): experts or third persons, when they are correctly installed, maintained and used.
p.(None): (2) The Bulgarian Drug Agency shall notify immediately the European Commission of the order under para.1
p.(None): and the measures taken, stating the reasons for the medical devices non-conformity with the requirements of this Act
p.(None): and the acts for its implementation, due to:
p.(None): 1. failure to meet the essential requirements referred to in the ordinances as per Art.18; 2. incorrect application of
p.(None): the standards referred to in Art.13, para.1;
...
p.(None): (2) The same punishment shall be imposed on a manager of a medical or health institution who allows utilization of
p.(None): devices without instructions for use or devices whose shelf life has expired.
p.(None): (3) (new – SG 54/12) A head of a medical or health establishment purchasing medical devices from persons without
p.(None): authorisation or another document certifying the right to trade in medical devices issued by a competent authority of a
p.(None): Member State or another contracting state to the Agreement on the European Economic Area, or of the Swiss
p.(None): Confederation, shall be imposed a fine amounting to BGN 10 000.
p.(None):
p.(None):
p.(None): Art. 130. Whoever carries out wholesale trade in medical devices whose shelf life has expired, shall be punished by a
p.(None): fine amounting to 10 000 BGN.
p.(None):
p.(None):
p.(None): Art. 131. (amend. – SG 54/12) A trader of medical devices, who breaches the requirements referred to in
p.(None): Art. 82, para 2, shall be punished by a propriety sanction amounting to 5000 BGN.
p.(None):
p.(None):
p.(None): Art. 132. (amend. – SG 54/12) A trader of medical devices, who breaches the requirements referred to in
p.(None): Art. 82, para 3, 4 or 5 shall be punished by a propriety sanction amounting to 1000 BGN.
p.(None):
p.(None):
p.(None): Art. 133. A wholesale trader of medical devices, who breaches the requirements referred to in Art. 82, para 1, items 2,
p.(None): 3 or 4 shall be punished by a propriety sanction amounting to 5000 BGN.
p.(None):
p.(None):
p.(None): Art. 134. (amend. – SG 54/12) Whoever carries out wholesale trade in medical devices without holding a document
p.(None): certifying his right to carry out such activity, shall be punished by a property sanction amounting to 10
p.(None): 000 BGN.
p.(None):
p.(None):
p.(None): Art. 134a. (new – SG 54/12) A wholesale trader in medical devices failing to perform their obligation
p.(None): under Art. 78a shall be imposed a property sanction amounting to BGN 10 000.
p.(None):
p.(None):
p.(None): Art. 135. (suppl. – SG 54/12) A wholesale trader who breaches the regulation of Art. 80, para 1 or 3 shall be punished
p.(None): by a propriety sanction amounting to 3000 BGN.
p.(None):
p.(None):
p.(None): Art. 136. (amend. - SG 60/11, in force from 05.08.2011; amend. – SG 54/12) A wholesale trader who
p.(None): breaches the regulation of Art. 80a, para 1 shall be punished by a propriety sanction amounting to 1000
p.(None): BGN.
p.(None):
p.(None):
p.(None): Art. 137. Whoever carries out retail trade in medical devices without CE marking affixed, or in medical devices whose
p.(None): shelf life has expired, shall be punished by a fine amounting to 10 000 BGN.
p.(None):
p.(None): Art. 138. (amend. – SG 54/12) Whoever carries out retail trade in medical devices outside health
p.(None): establishments under Art. 21, Para 2, Item 4 and Para 3 of the Health Act and/or outside the sites under Art. 83, para
p.(None): 1, item 4 - 7, shall be imposed a fine or a property sanction amounting to BGN 10 000.
p.(None):
p.(None):
p.(None): Art. 138a. (new – SG 54/12) A trader in medical devices violating the requirements of Art. 83b shall be imposed a
p.(None): property sanction amounting to BGN 1000.
p.(None):
p.(None):
p.(None): Art. 139. (amend. – SG 110/08) Whoever places on the market and/or puts into service medical devices on the territory
p.(None): of the Republic of Bulgaria without being registered within the prescribed term, shall be punished by a fine amounting
p.(None): to 5000 BGN.
p.(None):
p.(None):
p.(None): Art. 140. (amend. – SG 110/08, in force from 21.03.2010) Whoever violates the requirements of Art. 27, para 3, Art. 28,
p.(None): para 7, Art. 29, para 2 and Art. 30 shall be punished by a fine amounting to 3000 BGN.
p.(None):
p.(None):
p.(None): Art. 141. (1) Whoever breaches the requirements for carrying out clinical trials, if this does not constitute a crime,
p.(None): shall be punished by a fine amounting from 5000 to 10 000 BGN, and in the event of repeated violation - a fine
p.(None): amounting from 10 000 to 20 000 BGN.
p.(None): (2) A medical expert who has committed violations under para 1 may be punished with deprivation of right
p.(None): to exercise the profession for a period from six months to two years.
p.(None): (3) The punishment under para 2 shall be imposed by the Minister of Health upon proposal by the executive director of
p.(None): BDA.
p.(None):
p.(None):
p.(None): Art. 142. A notified body, which fails to meet the requirement as per Art. 68, para 1, shall be punished by a sanction
p.(None): amounting from 2000 to 5000 BGN.
p.(None):
p.(None):
p.(None): Art. 143. A notified body, which fails to meet the requirement as per Art. 70, para 1, shall be punished by a propriety
p.(None): sanction amounting to a maximum of 5000 BGN.
p.(None):
p.(None):
p.(None): Art. 143a. (new – SG 110/08; amend. - SG 38/15, in force from 26.05.2015)A notified body, which fails to meet the
p.(None): requirement as per Art. 76, para 3 and 4, shall be punished by a propriety sanction amounting to a
p.(None): maximum of 5000 BGN.
p.(None):
p.(None):
p.(None): Art. 144. Whoever impedes the persons as per Art. 86, para 2 to fulfill their official duties according
p.(None): to the provisions of Chapter VI, shall be punished by a fine amounting from 6000 to 10 000 BGN.
p.(None):
p.(None):
p.(None): Art. 145. A manufacturer of medical devices who violates the provision of Art. 103, para 1
p.(None):
p.(None): shall be punished by a propriety sanction amounting from 5000 to 10 000 BGN.
p.(None):
p.(None):
p.(None): Art. 146. A manufacturer of medical devices who violates the provision of Art. 107, shall be punished by a propriety
p.(None): sanction amounting from 10 000 to 20 000 BGN
p.(None):
p.(None):
p.(None): Art. 147. Whoever does not inform about an incident or a potential incident related to a medical device according to
p.(None): Art. 104, shall be punished by a fine amounting from 1000 to 2000 BGN.
p.(None):
p.(None):
p.(None): Art. 148. Whoever does not follow an order of the Executive director of BDA under Art. 113, para 4 shall be punished by
p.(None): a fine amounting from 10 000 to 20 000 BGN.
p.(None):
p.(None):
p.(None): Art. 149. Whoever breaches the provisions of this Act or the acts related to its implementation, apart from the cases
p.(None): referred to in Art. 119 through Art. 148, shall be punished by a fine amounting from 3000 to 5000 BGN.
p.(None):
p.(None):
p.(None): Art. 150. Whoever does not follow an order or instruction of BDA shall be punished by a fine amounting from 1000 to
p.(None): 3000 BGN.
p.(None):
p.(None):
p.(None): Art. 151. (1) Where the breaches referred to in Art. 119 through 150 are committed by legal entities or sole
p.(None): traders, property sanctions shall be imposed. The amount of the propriety sanctions imposed may not be less
p.(None): than the double size of the minimum amount of the respective fines and may not exceed the double amount of the minimum
p.(None): amount of the respective fines fixed.
p.(None): (2) Imposing propriety sanctions on the officials who have been found guilty does not exclude imposing fines on them.
p.(None):
p.(None):
p.(None): Art. 152. (amend. - SG 38/15, in force from 26.05.2015) (1) Breaches of this Act shall be established
p.(None): by acts compiled by inspectors and experts, appointed by an order of the Executive director of BDA.
p.(None): (2) Penal decrees shall be issued by the Executive director of BDA or by empowered by him/her officials.
p.(None):
p.(None):
p.(None): Art. 153. The drawing up of the acts, the issue, the appeal and the execution of the penal decrees
p.(None): shall be carried out pursuant to the Administrative Violations and Penalties Act.
p.(None):
p.(None):
p.(None): Additional provisions
p.(None):
p.(None):
p.(None): § 1. Within the meaning of this Act:
p.(None): 1. "Active implantable medical device" means any active medical device which is intended to be totally or partially
p.(None): introduced, surgically or medically, into the human body or by medical
p.(None):
p.(None): intervention into a natural orifice, and which is intended to remain in the body after the procedure.
p.(None): 2. "Active medical device" means any medical device relying for its functioning on a source of electrical energy or any
p.(None): source of power other than that directly generated by the human body or gravity.
p.(None): 3. "Valid documentation" means documentation which meets the requirements in terms of contents and
p.(None): completeness provided for in the respective procedure under this Act.
...
Social / Trade Union Membership
Searching for indicator union:
(return to top)
p.(None): (9) (suppl. – SG, 84/2012, in force from 02.01.2013) Where a medical device falls within the application field of the
p.(None): ordinances as per Art.7 of the =Technical Requirements to Products Act and/or Chapter Five “a” and of the
p.(None): ordinance under Art. 21e, Para. 1 of the Act on Protection against the Harmful Impact Of Chemical
p.(None): Substances And Mixtures, subject to CE marking, the marking certifies the compliance of the device with the
p.(None): requirements of each of the ordinances, unless otherwise
p.(None):
p.(None): stipulated therein.
p.(None): (10) At exhibitions, trade fairs, demonstrations, promotions, scientific and technical conferences
p.(None): can be presented medical devices without affixed CE marking.
p.(None): (11) In the cases referred to in para.10 manufacturers shall place a visible sign clearly indicating that
p.(None): such devices are not intended for placing on the market and/or putting into service.
p.(None):
p.(None):
p.(None): Art. 16 (1) Manufacturers of medical devices shall be obliged to specify their name,
p.(None): headquarters and business address on the device, its packing and instructions for use. Instruction for use is not
p.(None): required for devices under Art.2, para.1, item 3 from class I and IIa which, in the manufacturer’s opinion can be used
p.(None): safely without instructions for use.
p.(None): (2) The name and address of the authorized representative and of the importer are additionally specified on the
p.(None): packing and in the instructions for use of devices which are imported from third countries on the
p.(None): territory of the European Union or on the territory of the European Economic Area.
p.(None): (3) The instruction for use shall also be written in Bulgarian language.
p.(None):
p.(None):
p.(None): Art. 17. Manufacturers or their authorized representatives shall be obliged to ensure that medical devices
p.(None): are installed in a safe manner on the territory of the Republic of Bulgaria, where necessary due to
p.(None): their specific character according to the instruction for use, and to guarantee their maintenance.
p.(None):
p.(None):
p.(None): Art. 18. (amend. – SG 82/09, in force from 16.10.2009; amend. – SG, 14/15) Upon proposal by the Minister of Health and
p.(None): the Minister of Economy, the Council of Ministers shall determine by way of ordinance the following issues concerning
p.(None): medical devices referred to in Art.2. para.1:
p.(None): 1. essential requirements;
p.(None): 2. assessment conformity procedures regarding the essential requirements and the contents of the technical
p.(None): documentation;
p.(None): 3. rules for classification of medical devices referred to in Art.2, para.1, item 3; 4. the lists specifying the scope
p.(None): of groups of in-vitro diagnostic medical devices;
p.(None): 5. requirements for carrying out risk analysis and management with regards to medical devices as per Art.11, para.5.
p.(None):
p.(None):
p.(None): Section III.
p.(None): Putting on the market and/or putting into service of custom-made medical devices
p.(None):
p.(None): Art. 19. (1) (amend. – SG 110/08, in force from 21.03.2010) Prior to placing on the market and/or
p.(None): putting into service of a custom-made medical device under Art.2, para.1, item 2 or 3, the manufacturer
...
p.(None): (2) Imposing propriety sanctions on the officials who have been found guilty does not exclude imposing fines on them.
p.(None):
p.(None):
p.(None): Art. 152. (amend. - SG 38/15, in force from 26.05.2015) (1) Breaches of this Act shall be established
p.(None): by acts compiled by inspectors and experts, appointed by an order of the Executive director of BDA.
p.(None): (2) Penal decrees shall be issued by the Executive director of BDA or by empowered by him/her officials.
p.(None):
p.(None):
p.(None): Art. 153. The drawing up of the acts, the issue, the appeal and the execution of the penal decrees
p.(None): shall be carried out pursuant to the Administrative Violations and Penalties Act.
p.(None):
p.(None):
p.(None): Additional provisions
p.(None):
p.(None):
p.(None): § 1. Within the meaning of this Act:
p.(None): 1. "Active implantable medical device" means any active medical device which is intended to be totally or partially
p.(None): introduced, surgically or medically, into the human body or by medical
p.(None):
p.(None): intervention into a natural orifice, and which is intended to remain in the body after the procedure.
p.(None): 2. "Active medical device" means any medical device relying for its functioning on a source of electrical energy or any
p.(None): source of power other than that directly generated by the human body or gravity.
p.(None): 3. "Valid documentation" means documentation which meets the requirements in terms of contents and
p.(None): completeness provided for in the respective procedure under this Act.
p.(None): 4. "Importer" means natural or legal person established on the territory of a Member State or a state from the European
p.(None): Economic Area, who imports medical devices on the European Union market from third countries.
p.(None): 5. "Assignor of clinical investigation" is the manufacturer or their authorized representative in charge of initiation,
p.(None): management and/or financing of a clinical trial.
p.(None): 6. "Principal investigator" is the leader of the investigation team, carrying out clinical trial.
p.(None): 7. "Good clinical practice" means the entirety of internationally acknowledged ethical and scientific
p.(None): quality requirements which are to be met when planning, conducting, accounting and reporting of clinical trials.
p.(None): 8. "Member State" means a Member State of the European. 9. "Data allowing identification of the device" includes:
p.(None): a) information about the manufacturer, model and type number of the device, including software and
p.(None): appliances;
p.(None): b) intended use determined by the manufacturer, including clinical indications and
p.(None): contraindications during use and identification of the groups of patients for whom it has been
p.(None): designated;
p.(None): c) description of the device – description of materials that come into contact with human tissues or liquids, whether
p.(None): the devices comprises a medicinal product, human and/or animal tissues or derivatives, or biologically
p.(None): active substances;
p.(None): d) instructions for installation and use of the device, in case there are any special terms of
p.(None): preservation or function requirements – preliminary preparation before use – sterilization in cases of
p.(None): repeated use, safety check, measures that should be undertaken before use;
p.(None): e) recommended training and experience required for use of the device;
p.(None): f) description of the required medical and surgical procedures related to the use of the device;
...
p.(None): the human body for the purpose of obtaining a specimen within the meaning of Directive 93/42/EEC shall not
p.(None): be considered to be accessories to in vitro diagnostic medical devices;
p.(None): 30. "Manufacturer" means the natural or legal person who:
p.(None): a) is responsible for the design, manufacture, packaging and labelling of a device before it is
p.(None):
p.(None): placed on the market under his own name, regardless of whether these operations are carried out by that person himself
p.(None): or on his behalf by a third party;
p.(None): b) (amend. – SG 11/08) assembles, packages, processes, fully refurbishes and/or labels one or more ready-made products
p.(None): and/or assigns to them their intended purpose as devices with a view to their being placed on the market under his own
p.(None): name.
p.(None): Natural or legal persons who assembles or adapts devices already on the market to their intended purpose
p.(None): for an individual patient shall not be considered manufacturers within the meaning of this Act.
p.(None): 31. "Putting into service" means the stage at which a device has been made available to the final user as
p.(None): being ready for use in a Member State or a state from the European Economic Area for the first time for its intended
p.(None): purpose. of An active implantable medical device shall be considered put into service when made available to a
p.(None): qualified expert for implanting.
p.(None): 32. "Placing on the market" means the first making available in return for payment or free of charge of a device, other
p.(None): than a medical device for clinical trial and a device intended for performance evaluation, with a view to distribution
p.(None): and/or use on the territory of the European Union or the European Economic Area, regardless of whether it is new or
p.(None): fully refurbished.
p.(None): 33. "Serious health damage" means:
p.(None): 1. life-threatening condition, illness or harm;
p.(None): 2. lasting harm to the life functions or to a human organ or tissue;
p.(None): 3. a condition which requires medical or surgical intervention in order to prevent the damages under item 2;
p.(None): 34. "Human specimen receptacles" are those devices, whether vacuum-type or not, specifically intended by their
p.(None): manufacturers for the primary containment and preservation of specimens derived from the human body for the
p.(None): purpose of in vitro diagnostic examination.
p.(None): 35. "Essential amendment in the clinical trial plan" means any amendment in the plan and/or the information contained
p.(None): in the documentation that goes along with it, which affects:
p.(None): a) the safety or the physical and mental integrity of the persons involved; b) the scientific value of the
p.(None): investigation;
p.(None): c) the conducting or organization of the trial.
p.(None): 35a. (new - SG 38/15, in force from 26.05.2015) "Third country" shall mean any which is not an EU member or not a
p.(None): state - party to the Agreement on the European Economic Area or Swiss Confederation.
p.(None): 36. (amend. – SG 54/12) "Retail trade" are all activities related to acquisition, storage and sale of medical devices
p.(None): to the population.
p.(None): 37. (amend. – SG 54/12) "Wholesale trade" are all activities related to acquisition, storage, supply,
...
Social / Victim of Abuse
Searching for indicator trauma:
(return to top)
p.(None): office in a Member State or a state from the European Economic Area.
p.(None): 20. "Personal protective equipment" shall mean any equipment or device designed to protect a person against one or
p.(None): more hazards likely to endanger his safety and health. Personal protective equipment shall also be considered
p.(None): the following:
p.(None): a) entirety of equipment or devices or means interrelated by the manufacturer for the purpose of protecting a person
p.(None): from one or numerous hazards which may occur at the same time;
p.(None):
p.(None): b) protective equipment or device connected with a personal device with no protective function in a manner allowing or
p.(None): not separation, utilized by a person for a certain activity.
p.(None): c) replaceable compounds of a personal protective device, which are essential for its proper functioning
p.(None): and which are being used solely for the same personal device.
p.(None): 21. (amend. – SG 110/08, in force from 21.03.2010) "Medical device" means any instrument, apparatus, appliance,
p.(None): software, material or other device, whether used alone or in combination, including software, designated by the
p.(None): manufacturer to be used specifically for diagnostic and/or therapeutic purposes and required for its proper
p.(None): functioning, which does not achieve its principal intended action by pharmacological, chemical, immunological or
p.(None): metabolic means, but which may be assisted in its function by such means and which is intended by the
p.(None): manufacturer to be used for human beings for the purpose of:
p.(None): a) diagnosis, prevention, monitoring, treatment or alleviation of diseases;
p.(None): b) diagnosis, monitoring, treatment, alleviation or compensation of trauma or disability;
p.(None): c) investigation, replacement or modification of the anatomy or of a physiological process; d) control of conception
p.(None): process.
p.(None): 22. (amend. – SG 110/08, in force from 21.03.2010) "Device intended for clinical testing" means any
p.(None): medical device referred to in Art. 2, para 1, items 2 and 3, intended to be used by a medical specialist of by another
p.(None): specialist, having relevant for the testing purposes qualification, for conducting clinical testing in the medical
p.(None): establishment in order to achieve the objective referred to in Art. 32.
p.(None): 23. (amend. – SG 110/08) "Custom-made device" е means any medical device referred to in Art. 2, para 1, items 2 or 3,
p.(None): specifically made in accordance with a written prescription by a medical expert or a person with relevant
p.(None): professional qualification, which gives, under his/her responsibility, specific design characteristics of the
p.(None): device and is intended to be used only for an individual named patient.
p.(None): Mass-produced devices, adapted in order to meet the specific requirements of the medical practitioner or of
p.(None): any other trained user are not considered to be custom-made devices.
p.(None): 24. "Multi-centre clinical trial" means a clinical trial conducted according to a single trial plan but at more than
p.(None): one investigation centre/medical establishment, and therefore by more than one investigator. The
p.(None): investigation centres may be located in the territory of a single Member State, in a number of Member States
p.(None): and/or in Member States and third countries;
...
Social / Women
Searching for indicator women:
(return to top)
p.(None): significance, consequences and eventual risks and benefits of the clinical trial in a manner
p.(None): understandable for that person by a paediatrician or children’s psychologist.
p.(None): (4) The consent of the parents or the guardian must represent the minor's presumed will and may be revoked at any
p.(None): time, without detriment to the minor and/or to them.
p.(None): (5) The consent of an underage person, his/her parents and guardian can be withdrawn at any time without negative
p.(None): consequences for them.
p.(None):
p.(None):
p.(None): Art. 39. Where it is not possible to take urgent informed consent by the parent(s) or respectively by the guardian and
p.(None): the direct purpose to save the life of a minor, underage person, incapable or partially capable major, the decision to
p.(None): take part in a clinical investigation of any of the said persons shall be taken by at least two doctors, independent
p.(None): from the assignor and from the principal and coordinating investigator.
p.(None):
p.(None):
p.(None): Art. 40. (1) Clinical trials on pregnant women can be conducted according to the requirements as per Art. 37 only in
p.(None): those cases where there are no other alternative diagnostics or treatment methods and if it does not threaten the
p.(None): pregnant woman’s life and health and the fetus vitality.
p.(None): (2) Decision for involvement in a clinical investigation in the cases referred to in para 1 shall be taken by a
p.(None): committee of physicians, independent from the assignor and the principal and coordinating investigator.
p.(None):
p.(None):
p.(None): Art. 41. (1) Subjects shall be provided with further information throughout the clinical investigation by a
p.(None): person independent from the assignor upon request.
p.(None): (2) The written information provided to the subject during the clinical trial contains contact data of the independent
p.(None): person under para 1.
p.(None):
p.(None):
p.(None): Art. 42. (1) In those cases where an assignor who is not established on the territory of EU or on the territory of a
p.(None): state from the European Economic Area carries out one-site or multi-centre clinical trial on the territory of the
p.(None): Republic of Bulgaria, the latter shall authorize his/her representative established on the Republic of Bulgaria.
p.(None): (2) (amend. – SG 110/08, in force from 21.03.2010) In those cases where an assignor who is not established on the
p.(None): territory of the Republic of Bulgaria and on the territory of another Member State(s) and/or on the
p.(None): territory of a state/states from the European Economic Area and/or on the territory of a third country, he/she shall
p.(None): authorize a representative established on the territory of a state from EU or European Economic Area.
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.(None): witness shall certify in writing that the person has expressed informed consent to take part in the clinical trial in
p.(None): person.
p.(None): (3) The informed consent pursuant to para 1, item 3, and para 2 can only be given by a capable person who understands
p.(None): the nature, significance, scope, consequences, and potential risks of the clinical trial. Informed consent to
p.(None): participate in a clinical investigation can be withdrawn at any time without negative consequences for the person.
p.(None): (4) Clinical investigation of partially capable majors shall be carried out after they and their legal
p.(None): representative have expressed written informed consent. A partially capable person shall be provided with
p.(None): information under para 1, item 1 according to his/her capacity of understanding. The explicit wish of
p.(None): the person to be withdrawn at any time is considered by the investigator or, where appropriate, by the
p.(None): principal investigator.
p.(None): (5) Informed consent of an incapable major person shall be given by his/her legal
p.(None): representative.
p.(None): (6) In cases referred to in Art. 162, para 3 of the Health Act, informed consent shall be given by a person assigned by
p.(None): the court.
p.(None):
p.(None):
p.(None): Art. 38. (1) A clinical trial on a minor person shall be carried out after obtaining written informed
p.(None): consent by his/her legal representatives - both subject’s parents or the guardian pursuant to Art. 37, para
p.(None): 1, item 1 and 2 and para 3. Where one of the parents is unknown, deceased, or deprived of parental rights or such
p.(None): rights have not been delegated in case of divorce, written informed consent shall be given by the parent who exercises
p.(None): parental rights.
p.(None): (2) A clinical trial on an underage person shall be conducted after obtaining written informed
p.(None):
p.(None): consent by the subject and his/her legal representatives - both subject’s parents or the guardian
p.(None): according to Art. 37, para 1, item 1 and 2 and para 3. Where one of the parents is unknown, deceased, or deprived of
p.(None): parental rights or such rights have not been delegated in case of divorce, written informed consent shall be expressed
p.(None): by the parent who is exercising parental rights.
p.(None): (3) Minors or underage persons shall be provided with information about the nature,
p.(None): significance, consequences and eventual risks and benefits of the clinical trial in a manner
p.(None): understandable for that person by a paediatrician or children’s psychologist.
p.(None): (4) The consent of the parents or the guardian must represent the minor's presumed will and may be revoked at any
p.(None): time, without detriment to the minor and/or to them.
p.(None): (5) The consent of an underage person, his/her parents and guardian can be withdrawn at any time without negative
p.(None): consequences for them.
p.(None):
p.(None):
p.(None): Art. 39. Where it is not possible to take urgent informed consent by the parent(s) or respectively by the guardian and
p.(None): the direct purpose to save the life of a minor, underage person, incapable or partially capable major, the decision to
p.(None): take part in a clinical investigation of any of the said persons shall be taken by at least two doctors, independent
p.(None): from the assignor and from the principal and coordinating investigator.
p.(None):
p.(None):
p.(None): Art. 40. (1) Clinical trials on pregnant women can be conducted according to the requirements as per Art. 37 only in
p.(None): those cases where there are no other alternative diagnostics or treatment methods and if it does not threaten the
p.(None): pregnant woman’s life and health and the fetus vitality.
p.(None): (2) Decision for involvement in a clinical investigation in the cases referred to in para 1 shall be taken by a
p.(None): committee of physicians, independent from the assignor and the principal and coordinating investigator.
p.(None):
p.(None):
p.(None): Art. 41. (1) Subjects shall be provided with further information throughout the clinical investigation by a
p.(None): person independent from the assignor upon request.
p.(None): (2) The written information provided to the subject during the clinical trial contains contact data of the independent
p.(None): person under para 1.
p.(None):
p.(None):
p.(None): Art. 42. (1) In those cases where an assignor who is not established on the territory of EU or on the territory of a
p.(None): state from the European Economic Area carries out one-site or multi-centre clinical trial on the territory of the
p.(None): Republic of Bulgaria, the latter shall authorize his/her representative established on the Republic of Bulgaria.
...
Social / education
Searching for indicator education:
(return to top)
p.(None): certificates of medical devices for a period of 5 years and shall be presented upon request to the officials referred
p.(None): to in Art. 86.
p.(None): (5) (amend. – SG 54/12) The persons referred to in Para 1 shall be obliged to store the medical devices with expired
p.(None): term of validity, the blocked and/or withdrawn medical devices in a place designated for such purpose
p.(None): with permanent marking until their delivery to the manufacturer or their destruction.
p.(None):
p.(None):
p.(None): Art. 83. (amend. – SG 54/12) (1) The persons referred to in Art. 77 may carry out business transactions
p.(None): with medical devices, adhering to storage and distribution restrictions, with:
p.(None): 1. other wholesale traders within the meaning of this Act;
p.(None): 2. (amend. - SG 14/16, in force from 19.02.2016) medical establishments under the Medical Establishments
p.(None): Act and veterinary medical centers under the Veterinary Practice Act;
p.(None): 3. health institutions under Art. 21, Para 2, Items 1, 3 and 4 and Para 3 of the Health Act; 4. veterinary medical
p.(None): pharmacies;
p.(None):
p.(None): 5. drugstores;
p.(None): 6. persons carrying out activities of provision of aiding devices, accessories and equipment and medical devices to
p.(None): persons with disabilities under the Integration of Persons with Disabilities Act;
p.(None): 7. persons owning commercial sites where medical devices are offered as determined in an order of the
p.(None): Minister of Health or a deputy minister authorised by him;
p.(None): 8. municipalities, state authorities and state institution conducting public procurement procedures
p.(None): for supply of medical devices;
p.(None): 9. education institutions;
p.(None): 10. persons in a procedure for building and equipping future medical and health establishments following the receipt of
p.(None): a construction permit as set out in the Spatial Planning Act.
p.(None): (2) The Minister of Health shall determine in an order the medical devices, which may be sold in the commercial sites
p.(None): referred to in Para 1, Item 7.
p.(None):
p.(None):
p.(None): Art. 83b. (new – SG 54/12) (1) The persons referred to in Art. 78 and 78a shall keep information and
p.(None): store documentation of:
p.(None): 1. purchased and sold quantities of types of medical devices, the date of purchase and sale, warehouse
p.(None): availability, batch number and term of usability;
p.(None): 2. the name and address of management of the persons, from whom they have purchased or to whom they have sold the
p.(None): medical devices;
p.(None): 3. number and date of issue of the document, certifying the right to wholesale trade of the persons
p.(None): under Art. 77, and data identifying the issuing authority.
p.(None): (2) The persons referred to in Art. 83, Para 1, Items 3 – 5 and Items 7 – 10 shall keep information
p.(None): of:
p.(None): 1. purchased quantities of the types of medical devices, date of the purchase and sale, warehouse
p.(None): availability, batch number and term of usability;
p.(None): 2. the name and address of management of the person under Art. 77, from whom they have purchased the
p.(None): medical devices, and the data under Para 1, Item 3.
p.(None): (3) The persons referred to in Art. 83, Para 1, Items 2 and 6 shall keep information of:
p.(None): 1. purchased quantities of the types of medical devices, date of the purchase, warehouse availability,
p.(None): batch number and term of usability;
...
Social / parents
Searching for indicator parent:
(return to top)
p.(None): representative have expressed written informed consent. A partially capable person shall be provided with
p.(None): information under para 1, item 1 according to his/her capacity of understanding. The explicit wish of
p.(None): the person to be withdrawn at any time is considered by the investigator or, where appropriate, by the
p.(None): principal investigator.
p.(None): (5) Informed consent of an incapable major person shall be given by his/her legal
p.(None): representative.
p.(None): (6) In cases referred to in Art. 162, para 3 of the Health Act, informed consent shall be given by a person assigned by
p.(None): the court.
p.(None):
p.(None):
p.(None): Art. 38. (1) A clinical trial on a minor person shall be carried out after obtaining written informed
p.(None): consent by his/her legal representatives - both subject’s parents or the guardian pursuant to Art. 37, para
p.(None): 1, item 1 and 2 and para 3. Where one of the parents is unknown, deceased, or deprived of parental rights or such
p.(None): rights have not been delegated in case of divorce, written informed consent shall be given by the parent who exercises
p.(None): parental rights.
p.(None): (2) A clinical trial on an underage person shall be conducted after obtaining written informed
p.(None):
p.(None): consent by the subject and his/her legal representatives - both subject’s parents or the guardian
p.(None): according to Art. 37, para 1, item 1 and 2 and para 3. Where one of the parents is unknown, deceased, or deprived of
p.(None): parental rights or such rights have not been delegated in case of divorce, written informed consent shall be expressed
p.(None): by the parent who is exercising parental rights.
p.(None): (3) Minors or underage persons shall be provided with information about the nature,
p.(None): significance, consequences and eventual risks and benefits of the clinical trial in a manner
p.(None): understandable for that person by a paediatrician or children’s psychologist.
p.(None): (4) The consent of the parents or the guardian must represent the minor's presumed will and may be revoked at any
p.(None): time, without detriment to the minor and/or to them.
p.(None): (5) The consent of an underage person, his/her parents and guardian can be withdrawn at any time without negative
p.(None): consequences for them.
p.(None):
p.(None):
p.(None): Art. 39. Where it is not possible to take urgent informed consent by the parent(s) or respectively by the guardian and
p.(None): the direct purpose to save the life of a minor, underage person, incapable or partially capable major, the decision to
p.(None): take part in a clinical investigation of any of the said persons shall be taken by at least two doctors, independent
p.(None): from the assignor and from the principal and coordinating investigator.
p.(None):
p.(None):
p.(None): Art. 40. (1) Clinical trials on pregnant women can be conducted according to the requirements as per Art. 37 only in
p.(None): those cases where there are no other alternative diagnostics or treatment methods and if it does not threaten the
p.(None): pregnant woman’s life and health and the fetus vitality.
p.(None): (2) Decision for involvement in a clinical investigation in the cases referred to in para 1 shall be taken by a
p.(None): committee of physicians, independent from the assignor and the principal and coordinating investigator.
p.(None):
p.(None):
p.(None): Art. 41. (1) Subjects shall be provided with further information throughout the clinical investigation by a
p.(None): person independent from the assignor upon request.
p.(None): (2) The written information provided to the subject during the clinical trial contains contact data of the independent
p.(None): person under para 1.
p.(None):
p.(None):
p.(None): Art. 42. (1) In those cases where an assignor who is not established on the territory of EU or on the territory of a
p.(None): state from the European Economic Area carries out one-site or multi-centre clinical trial on the territory of the
...
Searching for indicator parents:
(return to top)
p.(None): the nature, significance, scope, consequences, and potential risks of the clinical trial. Informed consent to
p.(None): participate in a clinical investigation can be withdrawn at any time without negative consequences for the person.
p.(None): (4) Clinical investigation of partially capable majors shall be carried out after they and their legal
p.(None): representative have expressed written informed consent. A partially capable person shall be provided with
p.(None): information under para 1, item 1 according to his/her capacity of understanding. The explicit wish of
p.(None): the person to be withdrawn at any time is considered by the investigator or, where appropriate, by the
p.(None): principal investigator.
p.(None): (5) Informed consent of an incapable major person shall be given by his/her legal
p.(None): representative.
p.(None): (6) In cases referred to in Art. 162, para 3 of the Health Act, informed consent shall be given by a person assigned by
p.(None): the court.
p.(None):
p.(None):
p.(None): Art. 38. (1) A clinical trial on a minor person shall be carried out after obtaining written informed
p.(None): consent by his/her legal representatives - both subject’s parents or the guardian pursuant to Art. 37, para
p.(None): 1, item 1 and 2 and para 3. Where one of the parents is unknown, deceased, or deprived of parental rights or such
p.(None): rights have not been delegated in case of divorce, written informed consent shall be given by the parent who exercises
p.(None): parental rights.
p.(None): (2) A clinical trial on an underage person shall be conducted after obtaining written informed
p.(None):
p.(None): consent by the subject and his/her legal representatives - both subject’s parents or the guardian
p.(None): according to Art. 37, para 1, item 1 and 2 and para 3. Where one of the parents is unknown, deceased, or deprived of
p.(None): parental rights or such rights have not been delegated in case of divorce, written informed consent shall be expressed
p.(None): by the parent who is exercising parental rights.
p.(None): (3) Minors or underage persons shall be provided with information about the nature,
p.(None): significance, consequences and eventual risks and benefits of the clinical trial in a manner
p.(None): understandable for that person by a paediatrician or children’s psychologist.
p.(None): (4) The consent of the parents or the guardian must represent the minor's presumed will and may be revoked at any
p.(None): time, without detriment to the minor and/or to them.
p.(None): (5) The consent of an underage person, his/her parents and guardian can be withdrawn at any time without negative
p.(None): consequences for them.
p.(None):
p.(None):
p.(None): Art. 39. Where it is not possible to take urgent informed consent by the parent(s) or respectively by the guardian and
p.(None): the direct purpose to save the life of a minor, underage person, incapable or partially capable major, the decision to
p.(None): take part in a clinical investigation of any of the said persons shall be taken by at least two doctors, independent
p.(None): from the assignor and from the principal and coordinating investigator.
p.(None):
p.(None):
p.(None): Art. 40. (1) Clinical trials on pregnant women can be conducted according to the requirements as per Art. 37 only in
p.(None): those cases where there are no other alternative diagnostics or treatment methods and if it does not threaten the
p.(None): pregnant woman’s life and health and the fetus vitality.
p.(None): (2) Decision for involvement in a clinical investigation in the cases referred to in para 1 shall be taken by a
p.(None): committee of physicians, independent from the assignor and the principal and coordinating investigator.
p.(None):
p.(None):
p.(None): Art. 41. (1) Subjects shall be provided with further information throughout the clinical investigation by a
p.(None): person independent from the assignor upon request.
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.(None): the manufacturer or his/her authorized representative in the cases of par. 3 shall assign the carrying out of the
p.(None): procedures applicable to the device type to a notified authority of their choice within its competence.
p.(None): (5) (suppl. – SG 110/08) In those cases where medical devices under Art. 2, par. 1, item 3 have been produced
p.(None): utilizing non-viable animal tissue or non-viable product derived from animal tissues, prior to their
p.(None): conformity assessment under para.1 the manufacturer shall carry out risk analysis and management, observing
p.(None): the requirements set out in the ordinances as per Art.18 Art. 18.
p.(None): (6) (prev. par. 4, amend. – SG 110/08) The manufacturer or his/her authorized representative and the notified authority
p.(None): referred to in para.4 shall enter into an agreement concerning the terms and conditions of performing conformity
p.(None): assessment of medical devices.
p.(None):
p.(None):
p.(None): Art. 12. (1) (suppl. – SG 41/09, in force from 02.06.2009, amend., - SG 98/10, in force from 01.01.2011; amend. - SG
p.(None): 38/15, in force from 26.05.2015) As an exception, to the benefit of public health, the Minister of Health
p.(None): or an official authorized by him/her, may authorize the putting into service of a medical device, which does not
p.(None): meet the requirements of Art. 8, upon reasoned request by the Regional Health Inspectorate, of the
p.(None): National Centre of Public Health and Amalyses or of a medical establishment and provided that the Executive
p.(None): Director of BDA has expressed a positive opinion.
p.(None): (2) The terms and procedures for putting into service of medical devices under para.1 shall be determined by an
p.(None): ordinance by the Minister of Health.
p.(None):
p.(None):
p.(None): Art. 13. (1) (suppl. - – SG, 84/2012, in force from 02.01.2013) Where medical devices have been designed and
p.(None): manufactured according to national standards introducing the harmonized European standards, they shall be presumed to
p.(None): meet the essential requirements determined by the ordinances under Art.18 of this act and/or Chapter Five “a” and of
p.(None): the ordinance under Art. 21e, Para. 1 of the Act on Protection of Dangerous Impact of Chemical Substances and
p.(None): Mixtures.
p.(None): (2) (amend. – SG 110/08, in force from 21.03.2010) Where medical devices under Art.2, para.1, item 2
p.(None): and 3 have been designed and manufactured in conformity with the official pharmacopoeia in the
p.(None): Republic of Bulgaria determined in Art.12 of the Medicinal Products in Human Medicine Act, they shall be presumed to
p.(None): meet the essential requirements set out in the ordinances as per Art.18.
p.(None): (3) In case the medical devices referred to in Art.2, para.1, item 1 from List A, and where
p.(None):
p.(None): necessary, from List B, have been designed and manufactured in compliance with general technical
p.(None): specifications, they shall be presumed to meet the essential requirements set out in the ordinances as per Art.18.
p.(None): (4) In case a manufacturer is unable to observe the requirements under para.3, the latter shall approve technical
p.(None): decisions in order to achieve equivalent results.
p.(None): (5) In case BDA considers that standards under para.1 do not entirely meet the essential requirements set
...
p.(None): the sterile and user packing of the device.
p.(None): (8) In the case of overall processing of the device which can affect its safe use, the CE marking shall be affixed
p.(None): following a repeated assessment of the device in accordance with the applicable procedures set out in the
p.(None): ordinances as per Art.18.
p.(None): (9) (suppl. – SG, 84/2012, in force from 02.01.2013) Where a medical device falls within the application field of the
p.(None): ordinances as per Art.7 of the =Technical Requirements to Products Act and/or Chapter Five “a” and of the
p.(None): ordinance under Art. 21e, Para. 1 of the Act on Protection against the Harmful Impact Of Chemical
p.(None): Substances And Mixtures, subject to CE marking, the marking certifies the compliance of the device with the
p.(None): requirements of each of the ordinances, unless otherwise
p.(None):
p.(None): stipulated therein.
p.(None): (10) At exhibitions, trade fairs, demonstrations, promotions, scientific and technical conferences
p.(None): can be presented medical devices without affixed CE marking.
p.(None): (11) In the cases referred to in para.10 manufacturers shall place a visible sign clearly indicating that
p.(None): such devices are not intended for placing on the market and/or putting into service.
p.(None):
p.(None):
p.(None): Art. 16 (1) Manufacturers of medical devices shall be obliged to specify their name,
p.(None): headquarters and business address on the device, its packing and instructions for use. Instruction for use is not
p.(None): required for devices under Art.2, para.1, item 3 from class I and IIa which, in the manufacturer’s opinion can be used
p.(None): safely without instructions for use.
p.(None): (2) The name and address of the authorized representative and of the importer are additionally specified on the
p.(None): packing and in the instructions for use of devices which are imported from third countries on the
p.(None): territory of the European Union or on the territory of the European Economic Area.
p.(None): (3) The instruction for use shall also be written in Bulgarian language.
p.(None):
p.(None):
p.(None): Art. 17. Manufacturers or their authorized representatives shall be obliged to ensure that medical devices
p.(None): are installed in a safe manner on the territory of the Republic of Bulgaria, where necessary due to
p.(None): their specific character according to the instruction for use, and to guarantee their maintenance.
p.(None):
p.(None):
p.(None): Art. 18. (amend. – SG 82/09, in force from 16.10.2009; amend. – SG, 14/15) Upon proposal by the Minister of Health and
p.(None): the Minister of Economy, the Council of Ministers shall determine by way of ordinance the following issues concerning
p.(None): medical devices referred to in Art.2. para.1:
p.(None): 1. essential requirements;
p.(None): 2. assessment conformity procedures regarding the essential requirements and the contents of the technical
p.(None): documentation;
p.(None): 3. rules for classification of medical devices referred to in Art.2, para.1, item 3; 4. the lists specifying the scope
p.(None): of groups of in-vitro diagnostic medical devices;
p.(None): 5. requirements for carrying out risk analysis and management with regards to medical devices as per Art.11, para.5.
p.(None):
p.(None):
p.(None): Section III.
...
p.(None): requirements and procedures of the plan as approved by the ethics committee.
p.(None): (3) The principal or coordinating investigator shall be responsible in case of health damage or death caused during or
p.(None): in the occasion of clinical trial where the said trial has not been carried out in compliance with the requirements and
p.(None): procedures of the plan as approved by the ethics committee.
p.(None):
p.(None):
p.(None): Section II.
p.(None): Clinical Trial Authorizations
p.(None):
p.(None): Art. 45. (1) Clinical trials of medical devices referred to in Art. 2, para 1, item 3 from class III, of implantable
p.(None): medical devices and invasive medical devices for long-term use as per Art. 2, para 1, item 3 from class IIа or IIb
p.(None): and of devices under Art. 2, para 1, item 2, which take place on the territory of the Republic of Bulgaria can commence
p.(None): upon receiving a positive stand of the Multi-centre Research Ethics Committee or the ethics committee at the respective
p.(None): medical establishment, and an authorization by the Executive Director of the Bulgarian Drug Agency (BDA).
p.(None): (2) Clinical trials of medical devices other than the ones referred to in para 1 which take place on the territory of
p.(None): the Republic of Bulgaria can commence upon notification to the Executive Director of BDA, if the relevant ethics
p.(None): committee under para 1 has given a favourable opinion.
p.(None): (3) The provisions of para 1 and para 2 shall also apply to medical devices with applied "CЕ" marking in case the
p.(None): clinical trials are conducted with the purpose of change in their intended purpose.
p.(None):
p.(None):
p.(None): Art. 46. The assignor or the principal/coordinating investigator can submit an application form for notification or
p.(None): authorization for conducting a clinical trial to the relevant ethics committee and to BDA simultaneously or
p.(None): consequently.
p.(None):
p.(None):
p.(None): Art. 47. (1) In the case of multi-centre clinical trial on the territory of the Republic of Bulgaria persons as per
p.(None): Art. 46 shall submit an application form to the Multi-centre Research Ethics Committee.
p.(None): (2) In the case of one-site clinical trial on the territory of the Republic of Bulgaria persons
p.(None): referred to in Art. 46 shall submit an application form to the Multi-centre Research Ethics Committee or
p.(None):
p.(None): to the ethics committee at the respective medical establishment.
p.(None):
p.(None):
p.(None): Art. 48. (1) In order to obtain a stand by the relevant ethics committee, the principal, respectively
p.(None): the coordinating investigator or the assigner, shall provide:
p.(None): 1. administrative documentation; 2. information about the subject;
p.(None): 3. documents related to the study plan;
p.(None): 4. documentation on the medical device being investigated;
p.(None): 5. documents related to the technical specifications of the medical establishment and
p.(None): qualifications of the personnel;
p.(None): 6. information about the financing source and trial administrative organization.
p.(None): (2) The contents of documentation under para 1 is determined in an ordinance of the Minister of
p.(None): Health.
p.(None): (3) Where the ethics committee establishes that documentation under para 1 is incomplete it
p.(None): shall notify the applicant within 14 days and shall fix a deadline for completing the documentation.
p.(None): (4) Within 30 days after submission of the valid documentation the ethics committee passes a stand which shall be
p.(None): presented to the applicant and BDA.
p.(None):
p.(None):
p.(None): Art. 49. (1) If the opinion of the ethics committee as per Art. 48 is negative, the applicant can appeal before the
p.(None): Central Ethics Committee established under the Medicinal Products in Human Medicine Act within 14 days from
p.(None): the date of notification.
p.(None): (2) The Central Ethics Committee passes a stand within 14 days from the receipt date of the written request by the
p.(None): applicant.
p.(None): (3) The decision of the Central Ethics Committee shall be final and binding on the respective ethics committee.
p.(None):
p.(None):
p.(None): Art. 50. (1) (amend. – SG 110/08, in force from 21.03.2010) In order to get an authorization to conduct clinical test
p.(None): as per Art. 45, para 1, the applicant shall submit an application form to BDA with the following documentation
p.(None): attached:
p.(None): 1. identification data of the medical device on paper and electronic medium; 2. plan of clinical test;
p.(None): 3. researcher’s brochure;
p.(None): 4. documentation for obtaining of an informed consent;
p.(None): 5. manufacturer’s declaration whether the respective device may be determined as a device under Art. 3,
p.(None): item 2, 3 or 4;
p.(None): 6. manufacturer’s declaration whether for the production of the device under Art. 2, par. 1, item 3 non-viable animal
p.(None): tissue or non-viable products, produced from animal tissues, have been used;
p.(None): 7. the names of the researchers, of the general researcher or researchers or of the coordinating researcher, as well as
p.(None): the name and the address of the medical establishments, where the clinical testing is being carried out;
p.(None): 8. starting, closing date and schedule of the implemented tests;
p.(None): 9. positive reference of the ethics commission, where the applicant has submitted subsequent applications under Art.
p.(None): 46;
p.(None): 10. a declaration, that the medical device conforms with the applicable essential requirements, except those, which
p.(None): are subject to clinical testing, and that all preventive measures, required for protection of the health and
p.(None): safety of the participants in the testing and of the research team have been
p.(None):
p.(None): provided;
p.(None): 11. an insurance contract, covering the researcher’s and the applicant’s responsibility for caused proprietary and
p.(None): non-proprietary damages to the participants in the testing during or with reference to the implementation of the
p.(None): clinical testing;
p.(None): 12. a draft contract between the applicant and the medical establishment;
p.(None): 13. a document certifying paid fee to the amount determined in the tariff as per Art.7, para 1; (2) (revoked – SG
p.(None): 110/08, in force from 21.03.2010).
p.(None): (3) (amend. – SG 110/08, in force from 21.03.2010) In case of application forms as per Art. 46 submitted
p.(None): simultaneously, the applicant can present his/her opinion under para 1, item 9 after its obtaining, but
p.(None): not later than the term fixed under Art. 51, para 1.
p.(None): (4) (amend. – SG 110/08, in force from 21.03.2010) The applicant shall declare that the information,
p.(None): provided in the documents submitted to BDA and to the ethics commission is identical.
p.(None): (5) (new – SG 110/08, in force from 21.03.2010) The content of the documentation of par. 1 shall be determined by the
p.(None): ordinance of Art. 48, par. 2.
p.(None):
p.(None):
p.(None): Art. 51. (1) The Bulgarian Drug Agency assesses the provided documents as per Art. 50 within 60-days from the date of
p.(None): their submission.
p.(None): (2) (amend. – SG 110/08, in force from 21.03.2010) The Bulgarian Drug Agency may request additional information about
p.(None): the documents referred to in Art. 50, para 1.
p.(None): (3) In the cases referred to in para 2, the 60-day term shall stop running until the submission of the requested
p.(None): documentation.
p.(None): (4) Within the period under para 1, the Executive Director of BDA shall notify in writing the applicant that:
p.(None): 1. they issue an authorization to conduct the clinical trial or,
p.(None): 2. the trial may not be carried out, stating the reasons for refusal.
p.(None): (5) In the cases referred to in para 4, item 2, within 30 days from the date of notification, the applicant can submit
p.(None): to BDA an application amended in accordance with the reasons stated for refusal to conduct the clinical trial.
p.(None): (6) Within 30 days from the date of submission of the amended application under para 5, BDA shall inform the applicant
p.(None): in writing that:
p.(None): 1. they approve the conduct of the clinical trial, or
...
General/Other / Natural Hazards
Searching for indicator hazard:
(return to top)
p.(None): referred to in para 1, the applicant shall submit an application form along with
p.(None): the documents regarding the amendments, to the respective ethics committee and to BDA.
p.(None): (3) The ethics committee passes a stand within 15 days from receiving the application under para 2 and presents it to
p.(None): the assignor and BDA.
p.(None): (4) Within 15 days from the date of receiving the stand by the respective ethics committee, the Executive Director of
p.(None): BDA shall:
p.(None): 1. issue an amendment to the clinical trial authorization, approving the change in the trial plan,
p.(None): or
p.(None): 2. pass a well-grounded refusal for the substantial amendment referred to in para 1. (5) The refusal under para 4, item
p.(None): 2 shall not be subject to appeal.
p.(None): (6) If within the term under para 4 the applicant does not receive a refusal by BDA, he/she can
p.(None): carry out the clinical investigation according to the amended plan.
p.(None): (7) (new – SG 110/08, in force from 21.03.2010) In the cases of par. 4, item 2 in case of
p.(None): multi-center testing the BDA shall notify the regulatory authorities of the affected member States or the regulatory
p.(None): authorities of the states of the European Economic Area of the refusal and presents its reasons therefore.
p.(None):
p.(None):
p.(None): Art. 55. (1) Upon occurrence of any new event that is likely to affect the safety of the clinical trial subjects
p.(None): during its conduct, the sponsor and the investigator shall take appropriate urgent safety measures to
p.(None): protect the subjects against any immediate hazard.
p.(None): (2) (amend. – SG 110/08) In the cases referred to in para 1, the assignor can: 1. make amendments in the clinical
p.(None): testing plan;
p.(None): 2. terminate the clinical testing prior to the scheduled in the clinical testing plan term.
p.(None): (3) (amend. – SG 110/08) The assignor shall inform immediately the respective ethics committee and BDA:
p.(None): 1. of the undertaken measures, the reasons for them and the amendments made in the plan;
p.(None): 2. of the termination of the clinical testing prior to the scheduled in the clinical testing plan
p.(None): term.
p.(None): (4) (new – SG 110/08) In the cases under Art. 3, item 1 the BDA shall notify the regulating
p.(None): bodies of the affected member States or the regulatory authorities of the states of the European
p.(None): Economic Area, participating in the testing, of the undertaken measures and of the amendments of the plan and shall
p.(None): present the justifications thereof.
p.(None): (5) (new – SG 110/08) In the cases under Art. 3, item 2 the BDA shall notify the regulating bodies of the other member
p.(None): States, the regulatory authorities of the states of the European Economic
p.(None):
p.(None): Area and the European Commission of the premature termination of the clinical testing and shall present the
p.(None): justifications thereof.
p.(None):
p.(None):
p.(None): Art. 56. (1) (amend. – SG 110/08, in force from 21.03.2010) The assignor of the clinical testing is obliged to present
p.(None): to BDA upon request documentation containing:
p.(None): general description of the device and of its purpose of use;
p.(None): 2. design drawings, production methods, including the ones related to sterilization, diagrams of components and
p.(None): details, ways of connection, etc.;
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.(None): 1. ensuring the putting on the market and/or putting into service medical devices which do not threaten life and health
p.(None): of patients, medical experts or third persons when the devices are used according to their purpose and are being
p.(None): stored, distributed, installed, implanted and maintained according to the instructions manufacturers;
p.(None): 2. ensuring the implementation of Commission Regulation (EU) № 920/2013 of 24 September 2013 on the designation and the
p.(None): supervision of notified bodies under the Council Directive 90/385/EEC on active implantable medical devices and the
p.(None): Council Directive 93/42/EEC on medical devices_ (OJ, L 253/8 of 25 September 2013), hereinafter referred to as
p.(None): "Implementing Regulation (EU) № 920/2013.
p.(None):
p.(None):
p.(None): Art. 2. (1) Depending on the operation intended by the manufacturer, medical devices shall be categorised as follows:
p.(None): 1. in-vitro diagnostic medical devices; 2. active implantable medical devices;
p.(None): 3. medical devices other than the ones specified in items 1 and 2.
p.(None): (2) Medical devices under para.1, item 1 are classified in List A, List B and self-testing devices, as well as in other
p.(None): groups determined in the ordinances as per Art.18, depending on the potential risk related to them.
p.(None): (3) Depending on the potential risk related to them the medical devices under para.1, item 3 are
p.(None):
p.(None): grouped into class I, IIa, IIb and III according to classification rules set out in the ordinances
p.(None): under Art.18.
p.(None): (4) (amend. – SG 110/08, in force from 21.03.2010) In case the manufacturer and the notified authority determined
p.(None): pursuant to Chapter IV have different opinions regarding the implementation of the classification rules under
p.(None): para.3, the Bulgarian Drug Agency (BDA) shall take a decision. When it deems it appropriate and when
p.(None): the conditions under Art. 6a, item 1 or 2 are present, the BDA shall prepare a justified request to the
p.(None): European Commission for undertaking relevant measures.
p.(None): (5) (amend. – SG 110/08, in force from 21.03.2010) In case this is explicitly required, the
p.(None): classification rules under para.3 to be brought in compliance with new technologies development and/or with
p.(None): information received according to Chapter VII, BDA shall work out a reasoned request for undertaking the
p.(None): necessary measures which is to be submitted to the European Commission.
p.(None):
p.(None):
p.(None): Art. 3. The requirements for medical devices provided for in the present Act also apply to: 1. accessories to the
p.(None): devices;
p.(None): 2. devices including as an integral part a substance which, if used separately, may be considered to be a medicinal
p.(None): product within the meaning of the Medicinal Products in Human Medicine Act and which has an auxiliary effect on the
p.(None): organism with regards to the principal intended action of the device; 3. devices including as an integral part a
p.(None): substance obtained from human blood or plasma
p.(None): which, if used individually, may be considered a component of a medicinal product or a medicinal product
p.(None): under the Medicinal Products in Human Medicine Act and which has an auxiliary effect on the organism with regards to
...
p.(None): Member State or a state from the European Economic Area, they shall authorize in writing their
p.(None): representative, hereafter referred to as "authorized representative". For a medical device or a device of
p.(None):
p.(None): the same model, launched on the Community market, the manufacturer shall authorize only one person.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): shall be
p.(None): Art. 11. (1) (suppl. – SG, 84/2012, in force from 02.01.2013) Manufacturers of medical devices obliged to design,
p.(None): develop, produce, package and label them according to the essential
p.(None): requirements set out in the ordinances as per Art.18 and this act and/or of Chapter Five “a” and of the ordinance under
p.(None): Art. 21e, Para. 1 of the Act on Protection of Dangerous Impact of Chemical Substances and Mixtures, and to ensure
p.(None): assessment of their conformity by means of applicable procedures.
p.(None): (2) (amend. – SG 110/08) Conformity assessment under para.1 shall be carried out by the manufacturer.
p.(None): (3) (new – SG 110/08, suppl. – SG, 84/2012, in force from 02.01.2013) The manufacturer may assign to his authorized
p.(None): representative to apply the conformity assessment procedures, laid down in the ordinances of Art. 18 of this act and/or
p.(None): Chapter Five “a” and of the ordinance under Art. 21e, Para. 1 of the Act on Protection of Dangerous Impact of Chemical
p.(None): Substances and Mixtures.
p.(None): (4) (prev. par. 3, amend. – SG 110/08; amend. - SG 38/15, in force from 26.05.2015) In case the procedures provided
p.(None): for by the ordinances as per Art.18 require the interference of a notified authority under Art.63, para.4,
p.(None): the manufacturer or his/her authorized representative in the cases of par. 3 shall assign the carrying out of the
p.(None): procedures applicable to the device type to a notified authority of their choice within its competence.
p.(None): (5) (suppl. – SG 110/08) In those cases where medical devices under Art. 2, par. 1, item 3 have been produced
p.(None): utilizing non-viable animal tissue or non-viable product derived from animal tissues, prior to their
p.(None): conformity assessment under para.1 the manufacturer shall carry out risk analysis and management, observing
p.(None): the requirements set out in the ordinances as per Art.18 Art. 18.
p.(None): (6) (prev. par. 4, amend. – SG 110/08) The manufacturer or his/her authorized representative and the notified authority
p.(None): referred to in para.4 shall enter into an agreement concerning the terms and conditions of performing conformity
p.(None): assessment of medical devices.
p.(None):
p.(None):
p.(None): Art. 12. (1) (suppl. – SG 41/09, in force from 02.06.2009, amend., - SG 98/10, in force from 01.01.2011; amend. - SG
p.(None): 38/15, in force from 26.05.2015) As an exception, to the benefit of public health, the Minister of Health
p.(None): or an official authorized by him/her, may authorize the putting into service of a medical device, which does not
p.(None): meet the requirements of Art. 8, upon reasoned request by the Regional Health Inspectorate, of the
p.(None): National Centre of Public Health and Amalyses or of a medical establishment and provided that the Executive
p.(None): Director of BDA has expressed a positive opinion.
p.(None): (2) The terms and procedures for putting into service of medical devices under para.1 shall be determined by an
p.(None): ordinance by the Minister of Health.
p.(None):
p.(None):
p.(None): Art. 13. (1) (suppl. - – SG, 84/2012, in force from 02.01.2013) Where medical devices have been designed and
p.(None): manufactured according to national standards introducing the harmonized European standards, they shall be presumed to
p.(None): meet the essential requirements determined by the ordinances under Art.18 of this act and/or Chapter Five “a” and of
p.(None): the ordinance under Art. 21e, Para. 1 of the Act on Protection of Dangerous Impact of Chemical Substances and
p.(None): Mixtures.
p.(None): (2) (amend. – SG 110/08, in force from 21.03.2010) Where medical devices under Art.2, para.1, item 2
...
p.(None): of Art. 86, par. 2.
p.(None):
p.(None):
p.(None): Section IV.
p.(None): Placing on the market of systems or sets of medical devices
p.(None):
p.(None): Art. 21. (1) A natural or legal person who makes into sets medical devices referred to in Art. 2, para.1, item 3 with
p.(None): CE marking shall, prior to placing them on the market as a system or set, prepare a declaration stating that:
p.(None): 1. they have completed the system or set according to the purpose of the separate devices and the restrictions on their
p.(None): use determined by the manufacturers;
p.(None): 2. they have checked the conformity of the individual medical devices and have carried out the assembling procedures
p.(None): according to the instructions of manufacturers;
p.(None): 3. they have packed the system or set and they have provided the users with the necessary information
p.(None): including the respective manufacturers’ instructions;
p.(None): 4. their activity is subject to internal control and surveillance procedures.
p.(None): (2) In case any of the requirements of para.1 has not been met, the system or set shall be subject to conformity
p.(None): assessment regarding the essential requirements set out in the ordinances as per Art. 18.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Art. 21
p.(None): Art. 22. (1) A natural or legal person who sterilizes systems or sets of medical devices as per and/or medical
p.(None): devices referred to in Art. 2, para.1, item 3 with CE marking, which
p.(None): manufacturers have intended for sterilization before use, must assess their conformity by way of
p.(None): procedures set out in the respective ordinance as per Art.18.
p.(None): (2) (suppl. – SG 110/08) The implementation of the procedures set out in para.1 and the actions of the notified
p.(None): authority shall be restricted to meeting the sterility requirements up to the time of
p.(None):
p.(None): damaging of the integrity of device package.
p.(None): (3) The person referred to in para.1 shall draw up a declaration in accordance with the requirements set
p.(None): out in the respective ordinance, stating that sterilization has been carried out according to the manufacturers’
p.(None): instructions.
p.(None):
p.(None):
p.(None): Art. 23. (amend. – SG 110/08) The persons under Art. 21, para.1 and Art. 22, para.1 shall keep the declarations for
p.(None): a period of 5 years and shall present them to the persons referred to in Art. 86, para.2, upon request,
p.(None): in order to be reviewed.
p.(None):
p.(None):
p.(None): Art. 24. The systems or sets of medical devices under Art. 21, the sterilized systems or sets and the medical devices
p.(None): as per Art. 2, para.1, item 3 with CE marking, intended by the manufacturer for sterilization before use, shall
p.(None): be placed on the market without additional CE marking and shall be accompanied by instructions for use
p.(None): containing, where necessary, the information provided by the manufacturer of the individual devices in the
p.(None): system or set, the requirements for which are determined in the respective ordinance as per Art. 18.
p.(None):
p.(None):
p.(None): Section V.
p.(None): Performance evaluation of in-vitro diagnostic medical devices
p.(None):
p.(None): Art. 25. (1) The conformity assessment of in-vitro diagnostic medical devices regarding their specific purpose under
p.(None): conditions of use specified by the manufacturer shall be carried out by way of performance evaluation on the grounds
p.(None): of:
...
p.(None): (4) Para 2 shall not apply if there is imminent risk for the health and safety of the trial subjects. (5) The order
p.(None): under para 1 can be subject to appeal under the terms of the Administrative
p.(None): Procedure Code, provided that the appeal does not suspend its enforcement.
p.(None): (6) The principal or coordinating investigator notifies the clinical trial subjects of the order under
p.(None): para 1.
p.(None):
p.(None):
p.(None): Art. 60. (amend. – SG 110/08) (1) In case of termination of clinical testing the Executive Director of
p.(None): BDA shall notify immediately the regulatory authorities of the Member States of the regulatory bodies of
p.(None): the states of the European Economic Area and the European Commission of the order referred to in Art. 59, par. 1 and
p.(None): shall present justifications thereof.
p.(None): (2) In case of temporary suspension of the clinical testing the Executive Director of BDA shall notify immediately
p.(None): the regulatory authorities of the affected Member States or of the states of the European Economic Area,
p.(None): participating in the testing, of the ordinance referred to in Art. 59, par. 1 and shall present justifications thereof.
p.(None):
p.(None):
p.(None): Chapter four.
p.(None): NOTIFIED BODIES
p.(None):
p.(None): Art. 61. (amend. - SG 38/15, in force from 26.05.2015)
p.(None): (1) A conformity assessment authorization for medical devices, including clinical data assessment,
p.(None): shall be granted by the Executive Director of BDA to a natural or legal person, registered under the Commerce Act.
p.(None): (2) The Bulgarian Drug Agency shall be a designating authority for the purposes of Art. 1 letter "e" of Implementing
p.(None): Regulation (EU) № 920/2013.
p.(None): (3) A person applying for conformity assessment authorization of medical devices shall submit to BDA an application
p.(None): form on electronic media in accordance with Annex II of Implementing Regulation (EU) № 920/2013, stating the
p.(None): products and procedures applied for, areas of competence and the subdivisions of these areas - using the codes
p.(None): of the European Commission information system NANDO (New Approach Notified and Designated Organisations)
p.(None): and the annexes to the application referred to in Annex II of Implementing Regulation (EU) № 920/2013.
p.(None): (4) The applicant shall pay a fee for conformity assessment authorization of medical devices in the amount specified in
p.(None): the tariff under Art. 7, para. 1.
p.(None):
p.(None): Art. 62. (amend. - SG 38/15, in force from 26.05.2015) (1) The evaluation of a person applying for conformity
p.(None): assessment authorization of medical devices shall be carried out by an expert commission assigned by an order of the
p.(None): Executive Director of BDA. If necessary, in the commission may also be involved external experts who have knowledge and
p.(None): practical experience in the relevant medical devices.
p.(None): (2) Where a person applying for conformity assessment authorization for medical devices has stated medical devices
p.(None): under Art. 2 para. 1, item 1 in the application under Art. 61, para. 3, BDA shall perform assessment pursuant to Art.
p.(None): 62a.
p.(None): (3) Where a person applying for conformity assessment authorization for medical devices has stated medical devices
p.(None): under Art. 2 para. 1, item 2 or 3 in the application under Art. 61, para. 3, BDA shall perform the assessment
...
p.(None): shall notify the applicant in writing and shall set a two-months term for removal thereof. The term under
p.(None): Art. 63 para. 1 or 2 shall be suspended until the said inconsistencies are removed.
p.(None): (6) Where the applicant does not remove the inconsistencies in the time limit specified under para 5, the Executive
p.(None): Director of BDA shall refuse to grant authorization by a reasoned order.
p.(None): (7) Within 45 days after the on-site inspection the Commission or respectively the committees shall prepare a final
p.(None): assessment report, which shall be announced in the database of NANDO information system.
p.(None): Art. 63. (amend. - SG 38/15, in force from 26.05.2015) (1) In the cases referred to in Art. 62, para 2 and 4, based on
p.(None): the report under Art. 62a, para 7, the Executive Director of BDA shall notify the applicant that the latter is
p.(None): authorized for notification or shall issue a reasoned order for refusal thereof within 4-months term from submission of
p.(None): the documentation under Art. 61, para 3.
p.(None): (2) In the cases referred to in Art. 62, para 3, based on the report under Art. 62a, para 7, the Executive Director of
p.(None): BDA shall notify the applicant that the latter is authorized for notification or shall issue a reasoned order for
p.(None): refusal thereof within 6-months term from submission of the documentation under Art. 61, para 3.
p.(None): (3) Within 3 days from the notification under para 1 or para 2 the Executive Director of BDA announce the authorized
p.(None): through the NANDO system.
p.(None): (4) The identification number of the approved and notified to the European Commission
p.(None):
p.(None): conformity assessment authority, hereinafter referred to as "Notified Body", shall be determined by the European
p.(None): Commission.
p.(None): (5) The Executive Director of BDA shall issue a conformity assessment authorization to the Notified Body
p.(None): under para 4.
p.(None): (6) The authorization under para 5 shall have a maximum validity term of 5 years. Renewal of the said authorization
p.(None): shall be carried out pursuant to Art. 62, para 2 or para 3.
p.(None): Art. 64. (amend. - SG 38/15, in force from 26.05.2015) (1) When the person applying for conformity
p.(None): assessment authorization produces a certificate of accreditation according to the requirements
p.(None): specified in the ordinance under Art. 18, it shall be assumed that the said person has a functioning
p.(None): quality system, complies with the criteria of independence, impartiality and confidentiality and possesses the
p.(None): competence required.
p.(None): (2) In the cases referred to in para 1 the person shall not produce other documents certifying their conformity with
p.(None): the criteria under para 1.
p.(None): Art. 65. (amend. - SG 38/15, in force from 26.05.2015) Conformity assessment procedures stated in the
p.(None): Ordinance under Art. 18, may also be performed by Notified bodies from other Member States.
p.(None): Art. 66. (amend. - SG 38/15, in force from 26.05.2015) The authorization to conduct conformity assessment
p.(None): shall contain:
p.(None): 1.(amend. - SG 38/15, in force from 26.05.2015) name of the designating body;
p.(None): 2. name/company name, headquarters, business address and representative office of the notified
p.(None):
p.(None): body;
p.(None):
p.(None): 3. medical devices and conformity assessment procedures; 4. date of authorization issue;
...
p.(None): (4) (new - SG 38/15, in force from 26.05.2015) In the cases under par. 3 the notified body shall provide additional
p.(None): information upon request by the BDA and the documents requested by BDA.
p.(None): (5) (amend. – SG 110/08; prev. text of para 4, amend. - SG 38/15, in force from 26.05.2015) The Bulgarian Drug
p.(None): Agency shall inform the regulatory authorities of the other Member States, the regulatory authorities of the
p.(None): states - parties to the Agreement on the European Economic Area and of Swiss Confederation and the European Commission
p.(None): of the cases under par. 3.
p.(None):
p.(None):
p.(None): Art. 76a. (new – SG 110/08; amend. - SG 38/15, in force from 26.05.2015) The Notified bodies shall be obliged to
p.(None): provide to notified bodies, determined by other Member States, information on refused certificates, on
p.(None): certificates the validity of which has been suspended temporarily, on withdrawn certificates and, upon request, on
p.(None): issued certificates.
p.(None):
p.(None): Chapter five.
p.(None): TRADE IN MEDICAL DEVICES (TITLE AMEND. - SG 60/11, IN FORCE FROM 05.08.2011)
p.(None):
p.(None): Art. 77. (amend. – SG 54/12) (1) Wholesale trade in medical devices on the territory of the
p.(None):
p.(None): Republic of Bulgaria may be carried out by natural or legal persons registered as traders under Commerce
p.(None): Act or the legislation of a Member State or a contracting state of the Agreement on the European
p.(None): Economic Area, or the Swiss Confederation, holding an authorisation for wholesale trade in medical devices issued by
p.(None): BDA or another document certifying the right to trade in medical devices, issued by a competent authority of the
p.(None): respective state.
p.(None): (2) The manufacturers located in the territory of the Republic of Bulgaria may carry out commercial
p.(None): transaction with devices manufactured by them without the document referred to in Para 1.
p.(None):
p.(None):
p.(None): Art. 78. (amend. – SG 54/12) (1) Natural and legal persons registered under the Commerce Act or the legislation of a
p.(None): Member State or a contracting state to the Agreement on the European Economic Area, or the Swiss Confederation,
p.(None): wishing to obtain an authorisation for wholesale trade in medical devices shall file an application with
p.(None): BDA in a form approved by the executive director of BDA, accompanied by:
p.(None): 1. information of UIC of the persons registered under the Commerce Act and of the persons registered in a Member State
p.(None): or a contracting state to the Agreement on the European Economic Area, or the Swiss Confederation – information
p.(None): certifying their commercial registration;
p.(None): 2. a list of the categories medical devices according to the nomenclature system BDS EN ISO 15225 on the
p.(None): categorisation of the medical devices and their respective manufacturers on paper or magnetic career;
p.(None): 3. a document of paid fee in amount determined in the tariff referred to in Art. 7, Para 1.
p.(None): (2) If they have available premises for storage of medical devices on the territory of the Republic of
p.(None): Bulgaria, the persons under para 1 shall specify their address in the application. In this case the following documents
p.(None): shall also be enclosed to the documentation under para 1:
p.(None): 1. a statement that:
p.(None): a) the premises meet the requirements for storage of medical devices from the register under Para 1, Item 2 depending
p.(None): on their specifics and instructions of the manufacturer determined in the usage directions, and
p.(None): b) own or possess transportation means allowing their proper storage during distribution and transportation;
p.(None): 2. information of the name, permanent address and address for correspondence with the person determined to be
p.(None): responsible for the premises for storage and trade in medical devices and a copy of the contract by virtue of which
p.(None): have risen his legal relations with the applicant.
p.(None):
p.(None):
p.(None): Art. 78a. (new – SG 54/12) Where the persons referred to in Art. 77 hold a document certifying their right to wholesale
p.(None): trade in medical devices issued by a competent authority of a Member State or a contracting state to the Agreement on
p.(None): the European Economic Area, or the Swiss Confederation, and have premises for storage of medical devices on the
p.(None): territory of the Republic of Bulgaria, they shall file with BDA:
p.(None): 1. a notification form in a form approved by the executive director of BDA;
p.(None): 2. a copy of the document attesting their right to wholesale trade, accompanied by a translation in Bulgarian;
p.(None): 3. a list of the categories medical devices according to the nomenclature system BDS EN ISO 15225 for categorisation
p.(None): of the medical devices and their respective manufacturers on paper and magnetic career;
p.(None): 4. the documentation referred to in Art. 78, Para 2.
p.(None):
p.(None): Art. 79. (amend. – SG 54/12) (1) The Bulgarian Drug Agency shall check the documentation under Art. 78 and 78a. In
p.(None): cases of deficiencies in the documentation BDA shall notify the applicant in writing and shall provide a time limit for
p.(None): their remedy.
p.(None): (2) Within 30 days from the date of submission of the documentation under Art. 78 the executive
p.(None): director of BDA shall issue an authorisation for wholesale trade in medical devices to the persons under
p.(None): Art. 78, Para 1, and the information of their premises for storage and trading and the list of the categories of
p.(None): medical devices shall be recorded in the register under Art. 81.
p.(None): (3) The time limit under Para 2 shall be suspended from the date of the notification under Para 1 until the remedy of
p.(None): the deficiencies.
p.(None): (4) Within 7 days from the notification under Art. 78a the Bulgarian Drug Agency shall record in the register under
...
p.(None): pharmacies;
p.(None):
p.(None): 5. drugstores;
p.(None): 6. persons carrying out activities of provision of aiding devices, accessories and equipment and medical devices to
p.(None): persons with disabilities under the Integration of Persons with Disabilities Act;
p.(None): 7. persons owning commercial sites where medical devices are offered as determined in an order of the
p.(None): Minister of Health or a deputy minister authorised by him;
p.(None): 8. municipalities, state authorities and state institution conducting public procurement procedures
p.(None): for supply of medical devices;
p.(None): 9. education institutions;
p.(None): 10. persons in a procedure for building and equipping future medical and health establishments following the receipt of
p.(None): a construction permit as set out in the Spatial Planning Act.
p.(None): (2) The Minister of Health shall determine in an order the medical devices, which may be sold in the commercial sites
p.(None): referred to in Para 1, Item 7.
p.(None):
p.(None):
p.(None): Art. 83b. (new – SG 54/12) (1) The persons referred to in Art. 78 and 78a shall keep information and
p.(None): store documentation of:
p.(None): 1. purchased and sold quantities of types of medical devices, the date of purchase and sale, warehouse
p.(None): availability, batch number and term of usability;
p.(None): 2. the name and address of management of the persons, from whom they have purchased or to whom they have sold the
p.(None): medical devices;
p.(None): 3. number and date of issue of the document, certifying the right to wholesale trade of the persons
p.(None): under Art. 77, and data identifying the issuing authority.
p.(None): (2) The persons referred to in Art. 83, Para 1, Items 3 – 5 and Items 7 – 10 shall keep information
p.(None): of:
p.(None): 1. purchased quantities of the types of medical devices, date of the purchase and sale, warehouse
p.(None): availability, batch number and term of usability;
p.(None): 2. the name and address of management of the person under Art. 77, from whom they have purchased the
p.(None): medical devices, and the data under Para 1, Item 3.
p.(None): (3) The persons referred to in Art. 83, Para 1, Items 2 and 6 shall keep information of:
p.(None): 1. purchased quantities of the types of medical devices, date of the purchase, warehouse availability,
p.(None): batch number and term of usability;
p.(None): 2. the name and address of management of the person under Art. 77, from whom they have purchased the
p.(None): medical devices, and the data under Para 1, Item 3;
p.(None): 3. a person, to whom they have provided/applied the medical device/devices.
p.(None):
p.(None):
p.(None): Art. 84. (amend. – SG 54/12) (1) The officials referred to in Art. 86, para 2 shall carry out planned
p.(None): and unexpected inspections at the premises for storage and trade in medical devices.
p.(None): (2) The officials referred to in para 1 may require, inspect and make copies of the documents under Art. 82, paras 3
p.(None): and under Art. 83b, and take samples and specimens of the devices under the terms of Art. 93, para 3.
p.(None): (3) In case during the inspection it is established that medical devices do not comply with the requirements set out in
p.(None): Art. 82, para 1, items 1, 2 and 3, or that their shelf life has expired, the Executive Director of BDA shall order
p.(None): the devices to be blocked and withdrawn from the market and/or their destruction.
p.(None): (4) In case it is established that the premises for storage and trade do not meet the requirements determined by the
p.(None): manufacturer regarding certain device, the officials under para 1 shall give instructions and fix a term for
p.(None): eliminating these non-conformities.
p.(None): (5) In case the inspection ascertains that there are shortcomings or imperfections in the system
p.(None):
p.(None): as per Art. 82, para 3 or in the documentation of Art. 83b, the officials referred to in para 1 shall give instructions
p.(None): and fix a term for eliminating them.
p.(None): (6) In case the non-conformities, shortcomings and imperfections are not eliminated within the terms under para 4 and
p.(None): 5, the officials referred to in para 1 shall present a statement to the Executive Director of BDA, including a proposal
p.(None): to withdraw the authorization for wholesale trade, and in respect of the persons referred to in Art. 78a –
p.(None): removal from the register under Art. 81 and closing of their premises for storage and trading.
p.(None): (7) The orders of the Executive Director of BDA under para 3 and 6 may be appealed under the terms of the
p.(None): Administrative Procedure Code, and the appeal shall not suspend their implementation.
p.(None):
p.(None):
p.(None): Art. 85. (amend. – SG 54/12) The Bulgarian Drug Agency shall notify the regulatory authority of the other Member State
p.(None): or contracting state to the Agreement on the European Economic Area, or of the Swiss Confederation, that has issued the
p.(None): document certifying the right to wholesale trade in medical devices, of any violations related to wholesale trade in
p.(None): medical devices on the territory of the Republic of Bulgaria and shall provide information at the request of the
p.(None): persons under Art. 78.
p.(None):
p.(None):
p.(None): Chapter six.
p.(None): MARKET SUPERVISION
p.(None):
p.(None): Art. 86. (1) (suppl. – SG, 84/2012, in force from 02.01.2013) Market supervision is exercised to ensure that the
p.(None): medical devices placed on the market and/or put into service meet the requirements of the Act and the ordinances as per
p.(None): Art. 18 of this act and/or Chapter Five “a” and of the ordinance under Art. 21e, Para. 1 of the Act on
p.(None): Protection of the Dangerous Impact of Chemical Substances and Mixtures.
p.(None): (2) Market supervision on the territory of the Republic of Bulgaria is carried out by BDA through
p.(None): inspectors and experts appointed by an order of the Executive Director.
p.(None):
p.(None):
p.(None): Art. 87. (1) Market control is carried out by means of:
p.(None): 1. inspections of devices placed on the market and/or put into service; 2. taking samples and specimens of the devices
p.(None): and testing.
p.(None): (2) Trials of medical devices may not be carried out by the notified bodies involved in the conformity
p.(None): assessment of the same devices.
p.(None):
p.(None):
p.(None): Art. 88. Inspections of medical devices placed on the market and/or put into service shall be carried out according to:
p.(None): 1. approved in advance annual market supervision plan by groups of medical devices, respectively by the
...
p.(None): unjustified, the persons referred to in Art. 86, para 2 shall require from the manufacturer or his/her legal
p.(None): representative or from the importer to present within 10 days after the date of notification:
p.(None): 1. conformity declaration;
p.(None): 2. technical documentation as per Art. 14, para 1.
p.(None):
p.(None):
p.(None): Art. 92. (1) Persons as per Art. 86, para 2 pass a statement to the Executive Director of BDA who shall issue an order
p.(None): to block and ban on the distribution of devices, if within the term under Art. 91, para 4 the conformity declaration
p.(None): and technical documentation have not been submitted, except for the cases when the term under Art. 14, para 3 has
p.(None): expired.
p.(None): (2) Within 30 days from the date of handling the order under para 1, the manufacturer, his/her authorized
p.(None): representative or the importer are obliged to withdraw the device from the market.
p.(None):
p.(None): Art. 93. (1) (amend. – SG 110/08, suppl. – SG, 84/2012, in force from 02.01.2013) When upon inspection of the technical
p.(None): documentation under Art. 14, para 1 and of the conformity declaration of Art. 91, par. 4, item 1 doubts arise
p.(None): that the device does not meet the essential requirements, set in the ordinances under Art. 18 of this act
p.(None): and/or Chapter Five “a” and of the ordinance under Art. 21e, Para. 1 of the Act on Protection of the Dangerous Impact
p.(None): of Chemical Substances and Mixtures, the persons under Art. 86, para 2 shall take samples or specimens of the device to
p.(None): be tested.
p.(None): (2) The investigation is carried out in a laboratory accredited by the Executive Agency "Bulgarian
p.(None): Accreditation Service" or in laboratory accredited by an authority of a Member State or a state from the European
p.(None): Economic Area.
p.(None): (3) (amend. – SG 82/09, in force from 16.10.2009; amend. – SG, 14/15) The terms and the manner of
p.(None): taking samples and specimens of medical devices for testing are determined with an ordinance by the
p.(None): Minister of Health and by the Minister of Economy.
p.(None): (4) In case of the results of the conducted laboratory tests are disputed, within 7 days from the date of receiving the
p.(None): results from the initial test, the manufacturer or his/her authorized representative submits to BDA a written request
p.(None): for conducting a second test.
p.(None): (5) The second test under para 4 shall be carried out by experts who have not participated in the initial test.
p.(None):
p.(None):
p.(None): Art. 94. (1) In the cases referred to in Art. 93 the Executive Director of BDA shall issue an order for temporary ban
p.(None): on the distribution or use of the device in question.
p.(None): (2) Copy of the order under para 1 shall be given to the manufacturer or his/her authorized
p.(None): representative or the importer.
p.(None):
p.(None):
p.(None): Art. 95. Where persons as per Art. 86, para 2 find that the nonconformity with the essential requirements
p.(None): can be eliminated, they pass a statement to the Executive Director of BDA and give instructions with a
p.(None): deadline, coordinated with the manufacturer or his/her authorized representative, for carrying out the required
p.(None): corrective actions or for complete conformity assessment of the device with the essential requirements.
p.(None):
p.(None):
p.(None): Art. 96. (1) If the persons referred to in Art. 86, para 2 establish that the nonconformity with the essential
p.(None): requirements can not be elimeinated; they shall pass a statement to the Executive Director of BDA.
p.(None): (2) On the grounds of the statement under para 1, the Executive Director of BDA issues an order for
p.(None): block and ban on the distribution or use of the device and arranges its withdrawal from the market within 30 days
p.(None): from the date of handling the order to the manufacturer or his/her authorized representative or the
p.(None): importer.
p.(None): (3) BDA notifies the regulatory authority of the Member State where the manufacturer or his/her authorized
p.(None): representative and the importer are established of the order under para 2.
p.(None):
p.(None):
p.(None): Art. 97. The orders as per Art. 92, para 1, Art. 94, Art. 96, para 2 and Art. 99, para 1 are subject to appeal under
p.(None): the terms of the Administrative Procedure Code, provided that the appeal does not stop their enforcement.
p.(None):
p.(None):
p.(None): Art. 98. (1) In case during the trial under Art. 93 it is established that the medical devices do not
p.(None):
p.(None): comply with the essential requirements, the expenses for taking samples or specimens for testing are on the account of
p.(None): the manufacturer, his/her authorized representative or the importer.
p.(None): (2) In case during the test under Art. 93 it is ascertained that the medical devices comply with the essential
p.(None): requirements, the expenses for taking samples or specimens for testing are on the account of BDA.
p.(None):
p.(None):
p.(None): Art. 99. (1) (amend. – SG 110/08; suppl. – SG 41/09, in force from 02.06.2009) Upon a justified
p.(None): proposal by the Executive Director of BDA, where this is in public health interest and/or is required for
p.(None): the implementation of the national health policy, the Minister of Health or a deputy minister authorized by the latter
p.(None): may temporary by an ordinance:
p.(None): 1. prohibit launching on the market and/or putting into operation, or 2. prohibit the distribution, or
p.(None): 3. limit the scope of operation or
p.(None): 4. impose additional requirements for placing on the market and/or putting into service of a device or
p.(None): group of devices.
p.(None): (2) (suppl. – SG 110/08) In the cases referred to in para 1 BDA shall notify the European Commission
...
p.(None): 1. carried out corrective actions within the term specified by him/her in the report under Art.
p.(None): 112;
p.(None): 2. withdrawn the device or batch of devices from the market within the term specified by
p.(None): him/her in the report as per Art. 112;
p.(None): (5) The terms and procedures for blocking, withdrawal and/or destruction of devices which do not meet the requirements
p.(None): of this Act shall be determined by an ordinance of the Minister of Health.
p.(None):
p.(None):
p.(None): Art. 114. (1) The Bulgarian Drug Agency shall publish on its web site a list of the devices included
p.(None): in the ordinance under Art. 113, para 4.
p.(None): (2) In those cases where the devices under para 1 are being sold at sites as per Art. 83, para 2, BDA informs the
p.(None): public through BTA and the mass media.
p.(None): (3) The Executive Director of BDA issues a report on the incident that has occurred or the potential
p.(None): incident in cases referred to in Art. 112 and forwards a copy to the European Commission and the regulatory authorities
p.(None): of the Member States.
p.(None):
p.(None):
p.(None): Art. 115 (1) Any direct notice to BDA regarding an incident or potential incident with medical device on the territory
p.(None): of the Republic of Bulgaria, handed by an identified person in writing, shall be documented in the system under
p.(None): Art.109.
p.(None): (2) Within three days after receiving the notice for the incident or potential incident under para 1 BDA informs the
p.(None): manufacturer so that he/she undertakes the necessary measures defined under Art.106 - 108 and Art.112.
p.(None):
p.(None):
p.(None): Art. 116. BDA can be coordinating regulatory authority:
p.(None): 1. in the case of incident or potential incident which has occurred on the territory of more than one Member State or a
p.(None): state from the European Economic Area, and
p.(None): 2. in the event that the incident or the potential incident is registered for the first time on the territory of the
p.(None): Republic of Bulgaria, or
p.(None): 3. where the body which has carried out the conformity assessment of the device with the essential
p.(None): requirements has obtained an authorization under Chapter IV, if the incident or the potential incident has occurred
p.(None): with devices from class IIа, IIb or class III, or in-vitro diagnostic medical devices from list А or list B, or
p.(None): self-testing devices, or
p.(None):
p.(None): 4. in case the manufacturer or their authorized representative is registered at BDA under the terms of Chapter II, if
p.(None): the incident or the potential incident has occurred with devices from class I or in-vitro diagnostic medical devices
p.(None): which are not included in list A and list B and are not for self-testing ones.
p.(None):
p.(None):
p.(None): Art. 117. Personal data of the source of notice shall be stored by BDA according to the requirements of
p.(None): the Personal Data Protection Act.
p.(None):
p.(None):
p.(None): Chapter eight.
p.(None): EUROPEAN DATABASE
p.(None):
p.(None): Art. 118. Immediately upon receipt, the Executive Director of BDA presents to the European database the following
p.(None): information in a standard format:
p.(None): 1. (amend. – SG 110/08) data regarding the registration of the manufacturers or the authorized representatives of
p.(None): Art. 29 and the devices under Chapter II, except for the devices, which are customized;
...
p.(None): utilized safely without instructions for use, shall be punished by a fine amounting from 3000 to 5000 BGN.
p.(None):
p.(None):
p.(None): Art. 126. Whoever places on the market and/or puts into service systems and/or sets of medical devices intended by the
p.(None): manufacturer for sterilization before use in violation of the requirements of this Act and the acts related to its
p.(None): implementation, shall be punished by a fine amounting from 10 000 to 15 000 BGN.
p.(None):
p.(None):
p.(None): Art. 127. Whoever places on the market and/or puts into service custom-made medical devices in violation of the
p.(None): requirements of this Act, shall be punished by a fine amounting from 5000 to 10 000 BGN.
p.(None):
p.(None):
p.(None): Art. 128. Whoever carries out trade in medical devices without CE marking affixed, shall be punished by a fine
p.(None): amounting to 10 000 BGN.
p.(None):
p.(None):
p.(None): Art. 129. (1) A manager of a medical establishment who allows use of medical devices without
p.(None):
p.(None): affixed CE marking , except for the custom-made devices, and the ones which have been put into service before the
p.(None): entry into force of this Act, as well as the devices referred to in Art. 12, para 1, shall be
p.(None): punished by a fine amounting from 2000 to 10 000 BGN.
p.(None): (2) The same punishment shall be imposed on a manager of a medical or health institution who allows utilization of
p.(None): devices without instructions for use or devices whose shelf life has expired.
p.(None): (3) (new – SG 54/12) A head of a medical or health establishment purchasing medical devices from persons without
p.(None): authorisation or another document certifying the right to trade in medical devices issued by a competent authority of a
p.(None): Member State or another contracting state to the Agreement on the European Economic Area, or of the Swiss
p.(None): Confederation, shall be imposed a fine amounting to BGN 10 000.
p.(None):
p.(None):
p.(None): Art. 130. Whoever carries out wholesale trade in medical devices whose shelf life has expired, shall be punished by a
p.(None): fine amounting to 10 000 BGN.
p.(None):
p.(None):
p.(None): Art. 131. (amend. – SG 54/12) A trader of medical devices, who breaches the requirements referred to in
p.(None): Art. 82, para 2, shall be punished by a propriety sanction amounting to 5000 BGN.
p.(None):
p.(None):
p.(None): Art. 132. (amend. – SG 54/12) A trader of medical devices, who breaches the requirements referred to in
p.(None): Art. 82, para 3, 4 or 5 shall be punished by a propriety sanction amounting to 1000 BGN.
p.(None):
p.(None):
p.(None): Art. 133. A wholesale trader of medical devices, who breaches the requirements referred to in Art. 82, para 1, items 2,
p.(None): 3 or 4 shall be punished by a propriety sanction amounting to 5000 BGN.
p.(None):
p.(None):
p.(None): Art. 134. (amend. – SG 54/12) Whoever carries out wholesale trade in medical devices without holding a document
p.(None): certifying his right to carry out such activity, shall be punished by a property sanction amounting to 10
p.(None): 000 BGN.
p.(None):
p.(None):
p.(None): Art. 134a. (new – SG 54/12) A wholesale trader in medical devices failing to perform their obligation
p.(None): under Art. 78a shall be imposed a property sanction amounting to BGN 10 000.
p.(None):
p.(None):
p.(None): Art. 135. (suppl. – SG 54/12) A wholesale trader who breaches the regulation of Art. 80, para 1 or 3 shall be punished
...
Orphaned Trigger Words
p.(None): the ordinance under Art. 21e, Para. 1 of the Act on Protection of Dangerous Impact of Chemical Substances and
p.(None): Mixtures.
p.(None): (2) (amend. – SG 110/08, in force from 21.03.2010) Where medical devices under Art.2, para.1, item 2
p.(None): and 3 have been designed and manufactured in conformity with the official pharmacopoeia in the
p.(None): Republic of Bulgaria determined in Art.12 of the Medicinal Products in Human Medicine Act, they shall be presumed to
p.(None): meet the essential requirements set out in the ordinances as per Art.18.
p.(None): (3) In case the medical devices referred to in Art.2, para.1, item 1 from List A, and where
p.(None):
p.(None): necessary, from List B, have been designed and manufactured in compliance with general technical
p.(None): specifications, they shall be presumed to meet the essential requirements set out in the ordinances as per Art.18.
p.(None): (4) In case a manufacturer is unable to observe the requirements under para.3, the latter shall approve technical
p.(None): decisions in order to achieve equivalent results.
p.(None): (5) In case BDA considers that standards under para.1 do not entirely meet the essential requirements set
p.(None): out in the ordinances as per Art.18, it shall work out and harmonize an official state stand which is to be presented
p.(None): to the European Commission.
p.(None):
p.(None):
p.(None): Art. 14. (1) (suppl. – SG, 84/2012, in force from 02.01.2013) Manufacturers of medical devices shall prepare technical
p.(None): documentation the contents of which is determined in the relevant ordinances as per Art.18 of this act and/or of
p.(None): the ordinance under Art. 21e, Para. 1 of the Act on Protection of Dangerous Impact of Chemical Substances
p.(None): and Mixtures.
p.(None): (2) Manufacturers or their authorized representatives shall work out a declaration on the medical devices
p.(None): conformity following implementation of the applicable conformity assessment procedures.
p.(None): (3) Manufacturers or their authorized representatives shall be obliged to keep available the technical
p.(None): documentation under para.1 and the conformity declaration under para.2 for at least 5 years from the date of the
p.(None): suspension of the medical device manufacture and, upon request, to present to the persons referred to in Art.86, para.2
p.(None): for inspection.
p.(None):
p.(None):
p.(None): Art. 15. (1) The CE marking with graphic image according to the Appendix that is affixed on the medical device prior to
p.(None): its placing on the market and/or putting into service must be easy to read and impossible to efface without leaving
p.(None): traces.
p.(None): (2) The CE marking shall be placed on a visible spot on the device, in the instructions for use and on its sterile
p.(None): packing, if there is such. Where possible, it shall appear on the sales packaging.
p.(None): (3) The CE marking shall be at least 5 mm high, unless otherwise provided for in the relevant ordinance as per
p.(None): Art.18. If the CE marking size is being decreased or increased, the graphic scale proportions shall be
p.(None): adhered to.
p.(None): (4) (amend. – SG 110/08) The CE marking shall be accompanied by the identification number placed next to it of the
p.(None): notified body in the cases referred to in Art.11, para.4, where the procedures, contained in the ordinances of Art. 18
p.(None): require its displaying.
p.(None): (5) The CE marking and the identification number under para.4 shall not be placed on a device only if the size and form
...
p.(None):
p.(None):
p.(None): Section V.
p.(None): Performance evaluation of in-vitro diagnostic medical devices
p.(None):
p.(None): Art. 25. (1) The conformity assessment of in-vitro diagnostic medical devices regarding their specific purpose under
p.(None): conditions of use specified by the manufacturer shall be carried out by way of performance evaluation on the grounds
p.(None): of:
p.(None): 1. collective data from scientific literature relating to the purpose of the device, and a critical analysis of this
p.(None): data, and/or
p.(None): 2. the results from performance evaluation trials or other appropriate tests.
p.(None): (2) Manufacturers or their authorized representatives, prior to providing in-vitro diagnostic medical
p.(None): devices for performance evaluation to an accredited laboratory, shall prepare documentation containing the
p.(None): following:
p.(None): 1. data allowing identification of the device in question;
p.(None): 2. an evaluation plan stating in particular the purpose, scientific, technical or medical grounds, scope of the
p.(None): evaluation and number of devices concerned
p.(None): 3. a list of accredited laboratories taking part in the evaluation study;
p.(None): 4. the starting date and scheduled duration for the evaluations and, in the case of devices for self-testing, the
p.(None): location and number of lay persons involved;
p.(None): 5. in the case of self-testing devices – location and number of persons who have no medical qualification and will take
p.(None): part in the study;
p.(None): 6. a statement that the device in question conforms to the applicable essential requirements apart from
p.(None): the aspects covered by the evaluation and apart from those specifically itemised in the statement, and
p.(None): that every precaution has been taken to protect the health and safety of the patients, medical experts
p.(None): and other persons.
p.(None):
p.(None):
p.(None): Art. 26. (1) Manufacturers shall undertake to keep technical documentation as per Art.14, para.1 and shall
p.(None): provide it to the persons referred to in Art. 86, para.2, upon their request, for inspection.
p.(None): (2) Manufacturers shall be obliged to take all measures necessary for the manufacturing process to ensure the
p.(None): conformity of in-vitro diagnostic medical devices for performance evaluation with the
p.(None):
p.(None): documentation mentioned in para.1.
p.(None):
p.(None):
p.(None): Chapter two.
p.(None): REGISTRATION OF PERSONS LAUNCHING MEDICAL DEVICES ON THE MARKET (TITLE AMEND. – SG 110/08)
p.(None):
p.(None): Art. 27. (1) (amend. – SG 110/08, in force from 21.03.2010) Where manufacturers of medical devices as per Art. 2, para
p.(None): 1, item 3 from class I, manufacturers of custom-made devices under Art. 2, para 1, items 2 and 3, as well as natural or
p.(None): legal persons referred to in Art. 21, para 1 and Art. 22, para 1 are registered under the Commerce Act they shall
p.(None): submit an application for registration to the Executive Director of BDA within14 days from placing the device on the
p.(None): market and/or putting into service on the territory of the Republic of Bulgaria.
p.(None): (2) The following documents shall be appended to the registration form under para 1:
p.(None): 1. (amend. - SG 60/11, in force from 05.08.2011) a unified identity code of the company; 2. name and description of the
p.(None): device;
p.(None): 3. document certifying paid fee to the amount fixed in the tariff as per Art. 7, para 1.
p.(None): (3) (amend. – SG 110/08, in force from 21.03.2010) The persons referred to in para 1 are obliged to
...
p.(None): manufacturer;
p.(None): 2. identify adverse side effects under normal conditions of use of the device;
p.(None): 3. assess to what extend the indentified adverse side effects are within the acceptable risk assessed in
p.(None): comparison to the benefit of the intended purpose of use of the device.
p.(None):
p.(None):
p.(None): Art. 32a (new – SG 110/08, in force from 21.03.2010) The assessment of clinical testing data shall be carried out under
p.(None): the conditions, set out in the ordinance under Art. 48, par. 2.
p.(None):
p.(None):
p.(None): Art. 33. A clinical investigation shall be carried out in a medical establishment in accordance with the Medical
p.(None): Establishments Act.
p.(None):
p.(None):
p.(None): Art. 34. (1) Clinical investigations of devices referred to in Art. 32 shall be carried out according
p.(None): to the main principles of the protection of human rights, safety and human dignity of the clinical trial
p.(None): subjects according to the Declaration of Helsinki for the ethical principles of clinical trials with human subjects.
p.(None): (2) The rights, safety, and health of the subjects in the clinical test shall always prevail over those the interests
p.(None): of science and society.
p.(None): the interests of the patient always prevail over those of science and society
p.(None): (3) Clinical investigations shall be initiated and carried out provided that the estimated benefits for the subject and
p.(None): the society justify the risks.
p.(None): (4) Clinical trials shall be designed to minimise discomfort, pain, fear and any other foreseeable risks in relation to
p.(None): the disease and both the risk threshold and the degree of distress have to be defined in
p.(None):
p.(None): advance and constantly monitored throughout the investigation.
p.(None): (5) No financial or other incentives shall be given to clinical trial subjects except
p.(None): compensations (travel and daily costs, etc.).
p.(None):
p.(None):
p.(None): Art. 35. (revoked – SG 110/08, in force from 21.03.2010)
p.(None):
p.(None):
p.(None): Art. 36. (1) The whole information from a clinical investigation shall be recorded, processed and kept in such a manner
p.(None): as to ensure its precise reporting, interpretation, and confirmation. Personal data of the clinical trial subjects
p.(None): shall be preserved pursuant to the Protection of Personal Data Act.
p.(None): (2) The documentation under para 1 shall be stored by the principal or coordinating investigator for a period of 20
p.(None): years from the end date of the clinical trial and shall be presented to the relevant Ethics Committee(s)
p.(None): and to BDA upon request.
p.(None):
p.(None):
p.(None): Art. 37. (1) A clinical trial of the devices referred to in Art. 32 shall only be admitted on a
p.(None): person who:
p.(None): 1. has been provided in advance with written information about the nature, importance, consequences and
p.(None): potential risks of the investigation and has been informed in a prior interview by a doctor or dentist – member of the
p.(None): investigation team, about the objectives, risks and inconveniences of the trial and the conditions under which it is to
p.(None): be conducted;
p.(None): 2. has been informed of his/her right to withdraw from the investigation at any time without this having any negative
p.(None): consequences for him/her;
p.(None): 3. has personally expressed written informed consent to take part in the investigation.
p.(None): (2) If the individual is unable to write, oral consent in the presence of at least one witness may be given. The
p.(None): witness shall certify in writing that the person has expressed informed consent to take part in the clinical trial in
p.(None): person.
p.(None): (3) The informed consent pursuant to para 1, item 3, and para 2 can only be given by a capable person who understands
p.(None): the nature, significance, scope, consequences, and potential risks of the clinical trial. Informed consent to
p.(None): participate in a clinical investigation can be withdrawn at any time without negative consequences for the person.
p.(None): (4) Clinical investigation of partially capable majors shall be carried out after they and their legal
...
p.(None): medical device, the equivalency or which with the tested device can be proven, or
p.(None): c) published and/or non-published reports of another clinical examination of the tested device or of a similar medical
p.(None): device, the equivalency of which with the tested device can be proven.
p.(None): 16. "Coordinating investigator" is the person who coordinates the investigators during multi-centre
p.(None): clinical trials.
p.(None): 17. "Corrective actions" may include withdrawal of the device which has been put into service; issue of recommendations
p.(None): in writing specifying the measures that shall be undertaken; further tracing or modification of the device that
p.(None): has been put into service with the purpose of characteristics and performance improvement; amendment of the
p.(None): project; change of individual components of the device or change in the production process in the event of future
p.(None): manufacturing of such Art.s; amendment of the contents of the label or the instruction for use, etc.
p.(None): 14. "Critical analysis" means:
p.(None): a) short description of the medical device – intended operation, type, characteristics; b) analysis of the relevant
p.(None): literature and all the information available;
p.(None): c) critical analysis of the damages identified while using the device, the related risks and suitable
p.(None): safety measures as regards to patients, medical personnel and third parties;
p.(None): d) selection methods regarding the literature sources used, the statistics analysis methods, assessment
p.(None): methods applied, the investigation type and duration, heterogeneity and the population included in the
p.(None): investigation;
p.(None): e) final assessment of the benefit from the use of the device compared to the risk, taking into account the modern
p.(None): scientific achievements and the medical practice;
p.(None): f) conclusion pointing out whether the purposes set out in the tasks have been fulfilled, identification
p.(None): of shortcomings in the conformity assessment of the device with the essential requirements
p.(None): regarding safety and intended clinical effect, and, where necessary, reasons for conducting clinical trials – goals and
p.(None): plan of the investigation.
p.(None): 19. "A person, established on the territory of a Member State or a state from the European Economic
p.(None): Area" means a person registered according to the civil or trade legislation of a Member State or a state from the
p.(None): European Economic Area, or an entity established by a legislation act, having a business and registered
p.(None): office in a Member State or a state from the European Economic Area.
p.(None): 20. "Personal protective equipment" shall mean any equipment or device designed to protect a person against one or
p.(None): more hazards likely to endanger his safety and health. Personal protective equipment shall also be considered
p.(None): the following:
p.(None): a) entirety of equipment or devices or means interrelated by the manufacturer for the purpose of protecting a person
p.(None): from one or numerous hazards which may occur at the same time;
p.(None):
p.(None): b) protective equipment or device connected with a personal device with no protective function in a manner allowing or
p.(None): not separation, utilized by a person for a certain activity.
p.(None): c) replaceable compounds of a personal protective device, which are essential for its proper functioning
p.(None): and which are being used solely for the same personal device.
...
p.(None): 3. paragraph 21, which shall enter into force from June 1st 2010.
p.(None):
p.(None):
p.(None): Transitional and concluding provisions
p.(None): TO THE ACT ON AMENDMENT AND SUPPLEMENTATION OF THE TOURISM ACT
p.(None):
p.(None): (PROM. – SG 82/03, IN FORCE FROM 16.10.2009)
p.(None):
p.(None): § 59. This Act shall enter into force from the date of its promulgation in the State Gazette.
p.(None):
p.(None):
p.(None): Transitional and concluding provisions
p.(None): TO THE ACT ON AMENDMENT AND SUPPLEMENTATION OF THE MEDICAL DEVICES ACT
p.(None):
p.(None): (PROM. – SG 39/11, IN FORCE FROM 01.01.2012)
p.(None):
p.(None): § 4. Within two months from entry into force of this Act the Council of Ministers shall adopt an ordinance under Art.
p.(None): 30a, Para 3.
p.(None):
p.(None): § 5. This Act shall enter into force from 1 January 2012.
p.(None):
p.(None):
p.(None): Transitional and concluding provisions
p.(None): TO THE ACT ON AMENDMENT AND SUPPLEMENTATION OF THE MEDICINAL PRODUCTS IN UMAN MEDICINE ACT
p.(None):
p.(None): (PROM. – SG 60/11, IN FORCE FROM 05.08.2011)
p.(None):
p.(None): § 84. This Act shall enter into force from the day of its promulgation in the State Gazette, except
p.(None): for § 65, which shall enter into force from 30 September 2011.
p.(None):
p.(None):
p.(None): Transitional and concluding provisions
p.(None): TO THE ACT ON AMENDMENT AND SUPPLEMENTATION OF THE MEDICAL DEVICES ACT
p.(None):
p.(None): (PROM. – SG 54/12)
p.(None):
p.(None): § 28. The applications for issue of authorisations or certificates for wholesale trade in medical devices filed
p.(None): before entry into force of this Act shall be processed under the conditions and order stipulated therein.
p.(None):
p.(None):
p.(None): Transitional and concluding provisions
p.(None): TO THE ACT AMENDING AND SUPPLEMENTING THE ACT ON PROTECTION FROM THE DANGEROUS IMPACT OF CHEMICAL SUBSTANCES AND
p.(None): MIXTURES
p.(None):
p.(None): (PUBL. – SG 84/2012, IN FORCE FROM 02.01.2013)
p.(None):
p.(None): §13. The electric and electronic equipment (EEE) which does not fall in the scope of Annexes N 1 and 2 in the
p.(None): Ordinance on requirements for placing on the market EEE and treatment and transportation of EEE wastes
p.(None): (publ. SG, 36/2006; amend. 57/2006, 53/2008, 5/2009 and 29/2011) but does not comply with the requirements of Chapter
p.(None): Five “a” and the ordinance under Art. 21e, Para. 1, may continue to be provided on the market by 22 July 2019, if this
p.(None): is in compliance with § 12, p. 1 – 5.
p.(None):
p.(None):
p.(None): § 14. The council of Ministers shall adopt the ordinance under Art. 21e, Para. 1 within 3 month term from the
p.(None): publication of this act in the State Gazette.
p.(None):
p.(None):
p.(None): § 15. This act shall come into force from 2 January 2013.
p.(None):
p.(None):
p.(None): Transitional and concluding provisions
p.(None): TO THE ACT AMENDING AND SUPPLEMENTATING THE ACT ON PROHIBITION OF CHEMICAL WEAPONS AND ON CONTROL OF TOXIC CHEMICAL
p.(None): AGENTS AND THEIR PRECURSORS
p.(None):
p.(None): (PROM. – SG, 14/2015)
p.(None):
p.(None): § 20. In the Medical Devices Act the words "the Minister of Economy, Energy and Tourism" shall be replaced by "the
p.(None): Minister of Economy" and "the Ministry of Economy" everywhere.
p.(None):
p.(None): Concluding provisions
p.(None): TO THE ACT AMENDING AND SUPPLEMENTING THE MEDICAL DEVICES ACT
p.(None): (PROM. - SG 38/15, IN FORCE FROM 26.05.2015)
p.(None): § 32. The Act shall enter into force from the date of its promulgation in the State Gazette.
p.(None):
p.(None):
p.(None):
p.(None): Transitional and concluding provisions
p.(None): TO THE ACT AMENDING AND SUPPLEMENTING THE VETERINARY PRACTICE ACT
p.(None):
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| authority | Relationship to Authority |
| children | Child |
| crime | Illegal Activity |
| disability | Mentally Disabled |
| drug | Drug Usage |
| education | education |
| fetus | Fetus/Neonate |
| hazard | Natural Hazards |
| home | Property Ownership |
| illness | Physically Disabled |
| incapable | Mentally Incapacitated |
| language | Linguistic Proficiency |
| minor | Youth/Minors |
| opinion | philosophical differences/differences of opinion |
| parent | parents |
| parents | parents |
| party | political affiliation |
| pregnant | Pregnant |
| property | Property Ownership |
| restricted | Incarcerated |
| single | Marital Status |
| substance | Drug Usage |
| trauma | Victim of Abuse |
| union | Trade Union Membership |
| usage | Drug Usage |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| drug | ['substance', 'usage'] |
| home | ['property'] |
| parent | ['parents'] |
| parents | ['parent'] |
| property | ['home'] |
| substance | ['drug', 'usage'] |
| usage | ['drug', 'substance'] |
Trigger Words
capacity
consent
ethics
harm
protect
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input