MEDICAL DEVICES ACT

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MEDICAL DEVICES ACT Powered By Docstoc
					                               MEDICAL DEVICES ACT

Enforced on 12.06.2007
Promulgated SG No.46 of 12 June 2007



                                       Chapter One
                                     General Provisions

                                         Section I
                                     General Provisions
Art. 1 (1) The present Act shall regulate:
1. The terms and procedures for putting on the market and/or putting into service of medical
devices;
2. The obligations of the manufacturer, their authorized representative and the importer of
medical devices;
3. The terms and procedures for issuing authorization for assessing medical devices
conformity;
4. The terms and procedures for conducting clinical trials on medical devices;
5. The terms and procedures for wholesale trade with medical devices;
6. The control of medical devices market;
7. The system for notification and assessment of incidents/potential incidents connected with
medical devices.
(2) This Act aims to ensure the putting on the market and/or putting into service of medical
devices which do not threaten the life and health of patients, medical specialists or third
persons when the devices are stored, distributed, installed, implanted and maintained in
compliance with manufacturers’ instructions.

Art. 2 (1) According to the operation intended by the manufacturer, medical devices shall be
classified as follows:
1. In-vitro diagnostical medical devices;
2. Active implantable medical devices;
3. Medical devices other than specified in items 1 and 2.
(2) Medical devices under para.1, item 1, according to the potential risk connected with them,
are grouped into List A, List B and self-testing devices, and other groups defined in the
regulations under Art.18.
(3) Medical devices under para.1, item 3, according to the potential risk connected with them,
are divided into class I, IIa, IIb and III, in compliance with classification rules defined in the
regulations under Art.18.
(4) In case the manufacturer and the notified authority defined under Chapter 4 have different
opinion regarding the application of classification rules under para.3 the Bulgarian Drug
Agency (BDA) shall have the final decision.
(5) In case it is necessary to set the classification rules under para.3 in conformity with new
technologies development and/or in conformity with information received under the terms of
Chapter 7, BDA prepares an official state stand including a motivated request for taking the
necessary measures which is presented to the European Commission.
Art. 3 The medical devices requirements defined under this Act shall also apply to:


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1. Accessories to these devices;
2. Devices including as an integral part any substance which, used separately, can be defined
as a medicinal product under the Law on Medicinal Products in Human Medicine and which
has an auxiliary effect on the organism with regards to the principal use of the device;
3. Devices including as an integral part any substance obtained from human blood or plasma
which, used separately, can be defined as a component of a medicinal product or a medicinal
product under the Law on Medicinal Products in Human Medicine and which has an auxiliary
effect on the organism with regards to the principal use of the device;
4. Devices which help the application of medicinal products;

Art. 4 (1) When a certain product is included in the appendixes of this Act and of the
regulation under Art.7 of the Law on Technical Requirements for Products, regarding
personal protection devices, introducing Directive EEC 89/686 of the Council, the relevant
general safety requirements shall apply to it which are defined in the regulation.
(2) (In force as of 29.12.2009) When a certain product is included in the appendixes of this
Act and of the regulation under Art.7 of the Law on Technical Requirements for Products,
regarding machines, introducing Directive EU 2006/42 of the European Parliament and the
Council, the relevant essential safety requirements defined in the regulation shall apply to it,
provided that these requirements are more specific than those specified in the regulation under
Art.18.

Art. 5 (1) This Act shall not be applicable to:
1. Medicinal products under the Law on Medicinal Products in Human Medicine;
2. Medical devices which are an integral part of medicinal products and are intended by the
manufacturer for single use solely in this form;
3. Cosmetic products under the Health Act;
4. Organs, tissues and cells of human origin intended for transplantation, as well as products
containing or derived from tissues and cells of human origin under the Law on
Transplantation of Organs, Tissues and Cells;
5. Organs, tissues and cells of animal origin intended for transplantation, except when the
manufacture of the medical device requires the use of some non-viable animal tissue or non-
viable products obtained from animal tissue;
6. Blood, blood ingredients of human origin under the Law on Blood, Blood Donation and
Blood Transfusion, as well as devices which, upon release on the market, contain blood
products, plasma or blood cells, with the exception of medical devices under Art.3, item 3;
7. Medical devices under Art.2, para.1, item 1 which are not intended for release on the
market, which are used at the production site and, if used at sites in the immediate vicinity,
the ownership on them is not transferred on another legal entity;
(2) In the cases under para.1, item 2 the device must meet the requirements of the Law on
Medicinal Products in Human Medicine. The essential requirements defined under this Act
shall be applied only with regards to the characteristics connected with the safe functioning of
the device.

Art. 6 While implementing its powers under this Act, BDA:
1. Registers medical devices under the terms and procedures of Chapter 2;
2. Issues authorization for conducting clinical trials on medicinal products;
3. Issues authorization or certificates for wholesale trade in medical devices;
4. Supervises the medical devices that have been put on the market and/or put into service;
5. Controls the storage, wholesale trade, clinical trials and safety of medical devices;




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6. Keeps a system for registration and analysis of reports on incidents with medical devices
and takes the necessary measures;
7. It has its representatives in the Central Ethics Committee, established under the Law on
Medicinal Products in Human Medicine;
8. Provides information to the European Database regarding medical devices that have been
put on the market and/or put into service;
9. Participates in activities in the medical devices sphere connected with the work of
international authorities, organizations and agreements whereby the Republic of Bulgaria is a
party, together with the regulatory and control authorities of other countries and the
organizations working in the field of medical devices regulation;
10. Creates and keeps registers of medical devices, authorized clinical trials and licenses or
certificates for wholesale trade that have been issued.
11. Performs other activities provided for in this Act.

Art. 7 (1) For registration and issuing of registration certificates, for issuing of authorization
and certificates under this Act, as well as for entering amendments in them, fees shall be paid
the amount of which is defined in a tariff, ratified by the Council of Ministers.
(2) The amounts of fees under para.1 and of fines and property sanctions enforced on physical
and legal persons under this Act shall be deposited as budget revenue of BDA and the State
Agency for Metrological and Technical Control, in conformity with activities performed by
them under para.1.


                                     Section II
        Placing on the market and/or putting into service of medical devices

Art. 8 (1) Medical devices shall be put on the market and/or put into service provided that
they meet the requirements of this Act and its enforcement acts.
(2) Medical devices, except for custom-made, shall be put on the market and/or put into
service provided that they are affixed with CE marking under Art.15 which certifies that the
conformity of the devices to the essential requirements has been evaluated by means of the
applicable conformity assessment procedures.

Art. 9 (1) BDA Executive Director shall issue an ordinance for temporary suspension or
prohibition of putting on the market and/or putting into service and for withdrawal from the
market of medical devices with CE marking under Art.15, as well as of custom-made devices,
which can threaten the health and safety of patients, medical specialists or third persons, in
case they are properly installed, maintained and used.
(2) The Bulgarian Drug Agency shall inform immediately the European Commission on the
ordinance under para.1 and on the measures taken, specifying the reasons for the medical
devices non-conformity with the requirements of this Act and its enforcement acts, which can
be due to:
1. Failure to meet the essential requirements defined in the regulations under Art,18;
2. Improper application of standards under Art.13, para.1;
3. Shortcomings in standards under Art.13, para.1.

Art. 10 (1) The manufacturer is the person responsible for putting on the market and/or
putting into service of medical devices.
(2) In case the manufacturer is not established on the territory of a member state or a state
from the European Economic Area, they shall authorize in writing a representative,


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established on the territory of the European Union, hereafter referred to as “authorized
representative”.

Art. 11 (1) The manufacturer of medical devices shall be obliged to design, develop,
manufacture, package and label them in compliance with the essential requirements defined in
the regulations under Art.18 and to ensure assessment of their conformity by means of
applicable procedures.
(2) Conformity assessment under para.1 is performed by the manufacturer or their authorized
representative.
(3) In case the procedures defined in the regulations under Art.18 require the intervention of a
notified authority under Art.64, para.2, the manufacturer assigns a notified authority of their
choice to implement within its competence the procedures applicable to the device type.
(4) The manufacturer or their authorized representative and the notified authority under para.3
enter into an agreement regarding the terms of performing assessment of medical devices
conformity.
(5) In cases of manufacturing of medical devices by use of non-viable animal tissue or non-
viable product obtained from animal tissues, before assessing their conformity under para.1
the manufacturer shall perform risk analysis and risk management, observing the
requirements defined in the regulations under Art.18.

Art. 12 (1) To the benefit of public health and at the motivated request of the Regional
Inspectorate for Protection and Control of Public Health (RIPCPH), of the National Centre for
Public Health Issues or of a medical institution, the Minister of Health can, upon BDA
Executive Director’s positive stand, authorize with an ordinance and as an exception the
putting into service of a medical device, without the presence of the terms under Art.8.
(2) The terms and procedures for putting into service of medical devices under para.1 are
defined by a regulation by the Minister of Health.

Art. 13 (1) When medical devices have been designed and manufactured in compliance with
national standards that introduce the harmonized European standards, they shall be assumed
to meet the essential requirements defined in the regulations under Art.18.
(2) When medical devices under Art.2, para.1, item 3 have been designed and manufactured
in compliance with the official pharmacopoeia in the Republic of Bulgaria defined in Art.12
of the Law on Medicinal Products in Human Medicine, they shall be assumed to meet the
essential requirements defined in the regulations under Art.18.
(3) When medical devices under Art.2, para.1, item 1 from List A, and if necessary, from List
B, have been designed and manufactured in compliance with general technical specifications,
they shall be assumed to meet the essential requirements defined in the regulations under
Art.18.
(4) In case the manufacturer cannot observe the requirements under para.3, they shall approve
technical decisions which help achieve an equivalent result.
(5) In case BDA establishes that standards under para.1 do not cover entirely the essential
requirements defined in the regulations under Art.18. it shall prepare and harmonize an
official state stand which shall then be presented to the European Commission.

Art. 14 (1) The manufacturer of medical devices shall prepare technical documentation the
contents of which is defined in the relevant regulations under Art.18.
(2) After implementation of the applicable procedures for conformity assessment, the
manufacturer or their authorized representative shall draw up a declaration on the medical
devices conformity.


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(3) The manufacturer or their authorized representative shall be obliged to store the technical
documentation under para.1 and the conformity declaration under para.2 at least 5 years after
the suspension of the medical device manufacture and to present them, upon request, for
inspection to the persons under Art.86, para.2.

Art. 15 (1) The CE marking with graphic image in accordance with the Appendix that is put
on the medical device before its putting on the market and/or putting into service must be easy
to read and impossible to efface without leaving traces.
(2) The CE marking is put on a visible spot on the device, in the instructions for use and on its
sterile packing, if available. When possible, it is also put on the user packing.
(3) The CE marking has a height of at least 5 mm, unless otherwise stipulated in the relevant
regulation under Art.18. When decreasing or increasing the CE marking size, the proportions
in the graphic scale must be adhered to.
(4) Next to the CE marking under para.1 the identification number of the notified authority in
the cases under Art.11, para.3 is placed.
(5) The CE marking and the identification number under para.4 shall not be put on the device
only when the size and form of the device do not allow it.
(6) Any other marking which is put on the device, its packing and/or its instructions for use
should not mislead the user – medical specialist, or patient, as to the marking under para.1 and
should not reduce visibility and legibility.
(7) In the case of devices that are put on the market in a sterile packing, the CE marking is put
on both the sterile and user packing of the device.
(8) In the case of total remaking of the device which can affect its safe use, the CE marking is
put after a second assessment of the device in accordance with the applicable procedures
defined in the regulations under Art.18.
(9) When the medical device is included in the appendixes of the regulations under Art.7 of
the Law on Technical Requirements for Products subject to CE Marking, the marking certifies
the conformity of the device with the requirements of each of the regulations, unless
otherwise stipulated in the regulations.
(10) At exhibitions, fairs, displays, promotions, scientific and technical conferences medical
devices without CE marking can be presented.
(11) In the cases under para.10 the manufacturer puts a visible designation on the devices
which shows unambiguously that they are not intended for putting on the market and/or
putting into service.

Art. 16 (1) The manufacturer of medical devices shall be obliged to specify their name,
headquarters and business address on the device, its packing and instructions for use.
Instruction for use is not required for devices under Art.2, para.1, item 3 from class I and IIa
which, in the manufacturer’s opinion can be used safely without instructions for use.
(2) The name and address of the authorized representative and of the importer are additionally
specified on the packing and in the instructions for use of devices which are imported from
third countries on the territory of the European Union or on the territory of the European
Economic Area.
(3) The instruction for use must be written in Bulgarian as well.

Art. 17 The manufacturer or their authorized representative shall be obliged to ensure the safe
installation of the medical devices on the territory of the Republic of Bulgaria, in case this is
required by their specificity according to the instruction for use, and to guarantee their
maintenance.




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Art. 18 At suggestion by the Minister of Health and the Minister of Economics and
Energetics, the Council of Ministers defines by way of regulations regarding the medical
devices under Art.2. para.1:
1. The essential requirements;
2. The procedures for assessing conformity with the essential requirements and the content of
the technical documentation.
3. The rules for classification of medical devices under Art.2, para.1, item 3;
4. The lists defining the range of groups of in-vitro diagnostic medical devices;
5. The requirements for performing risk analysis and risk management for medical devices
under Art.11, para.5.

                                   Section III
    Putting on the market and/or putting into service of custom-made medical
                                     devices

Art. 19 (1) Prior to putting on the market and/or putting into service of a medical device
under Art.2, para.1, item 2 or 3, which is custom-made, the manufacturer or their authorized
representative shall prepare documentation consisting of:
1. Identification data of the device;
2. A declaration specifying that the medical device is designed for special use by a particular
patient whose name is indicated;
3. The name of the physician or dental physician who has prepared the specification for the
manufacture of the device, and the name of the medical institution, when possible;
4. The characteristics of the medical device according to the specification:
5. A declaration where it is stated that the device complies with the applicable essential
requirements.
(2) In the cases when the device does not meet any of the applicable essential requirements,
the non-conformity is in the declaration under para.1, item 5.
(3) The documentation under para.1 shall be stored by the manufacturer or their authorized
representative for at least 5 years.
(4) The manufacturer of medical devices under Art.2, para.1, item 2 or 3, which are custom-
made provides, on BDA’s request, a list of the devices which have been put into service on
the territory of Bulgaria.

Art. 20 (1) The manufacturer prepares technical documentation under Art.14, para.1 and, on
request, presents it for inspection to the persons under Art.86, para.2.
(2) The manufacturer shall be obliged to take the necessary measures to ensure by way of the
production process the conformity of the devices under Art.19 with the documentation under
para.1.

                                     Section IV
             Putting on the market of systems or sets of medical devices
Art. 21 (1) A physical or legal person who completes medical devices under Art.2, para.1,
item 3 with CE marking shall, prior to putting them on the market as a system or set, prepare a
declaration in which they state that:
1. They have completed the system or set according to the purpose of the separate devices and
the restrictions on their use determined by the manufacturers;
2. They have checked the conformity of the individual medical devices and have performed
the assembling procedures in accordance with the manufacturers’ instructions;


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3. They have packed the system or set and they have provided the users with the necessary
information which includes the relevant instructions by manufacturers;
4. Their activities are subject to relevant procedures for internal control and inspection.
(2) In case any of the requirements under para.1 has not been met, the system or set shall be
subject to assessment of conformity with the essential requirements defined in the regulations
under Art.18.

Art. 22 (1) A physical or legal person who sterilizes systems or sets of medical devices under
Art.21 and/or medical devices under Art.2, para.1, item 3 with CE marking, intended by the
manufacturer to be sterilized before use, must assess their conformity by way of procedures
defined in the relevant regulation under Art.18.
(2) The application of procedures under para.1 and the actions of the notified authority shall
be limited to meeting the sterility requirements;
(3) The person under para.1 prepares a declaration in accordance with the requirements
stipulated in the relevant regulation, stating that the sterilization has been performed in
compliance with the manufacturers’ instructions.


Art. 23 The persons under Art.21, para.1 and Art.22, para.1 shall store the declarations for at
least 5 years after the production date and shall present them, on request, for inspection to the
persons under Art.86, para.2.

Art. 24 The systems or sets of medical devices under Art.21, the sterilized systems or sets and
the medical devices under Art.2, para.1, item 3 with CE marking, intended by the
manufacturer to be sterilized before use, shall be put on the market without additional CE
marking and accompanied by instructions for use which include, if necessary, the information
provided by the manufacturer of the individual devices in the system or set, the requirements
for which are defined in the relevant regulation under Art.18.

                                    Section V
           Assessment of operation of in-vitro diagnostic medical devices
Art. 25 (1) The assessment of conformity of in-vitro diagnostic medical devices with their
specific purpose under conditions of use defined by the manufacturer shall be performed by
way of operation assessment on the basis of:
1. Collective data from scientific literature relating to the purpose of the device, and a critical
analysis of this data, and/or
2. The results of the trials for assessing operation or some other suitable tests.
(2) The manufacturer or their authorized representative, prior to providing in-vitro diagnostic
medical devices for assessment of operation to a accredited laboratory, shall prepare the
following documentation consisting of:
1. Identification data of the device;
2. Assessment plan containing the goal, the scientific, technical or medical grounds, the
assessment scope and the number of devices;
3. A list of accredited laboratories participating in the assessment;
4. Start date and expected duration of the assessment;
5. In the case of self-testing devices – location and number of persons with no medical
qualification who will participate in the study;
6. A declaration stating that the medical device meets the applicable essential requirements,
except for those which are subject to operation assessment and are explicitly specified, and


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that all precautions have been taken necessary for protecting the health and safety of medical
specialists, patients and third persons.

Art. 26 (1) The manufacturer prepares technical documentation under Art.14, para.1 and
presents it, upon request, for inspection to the persons under Art.86, para.2.
(2) The manufacturer shall be obliged to take the necessary measures to ensure by way of the
production process the conformity of in-vitro diagnostic medical devices for operation
assessment with the documentation under para.1.


                                       Chapter II
                               Medical Device Registration

Art. 27 (1) When the manufacturer of medical devices under Art. 2, par. 1, item 3 from class
I, the manufacturer of devices under Art. 2, par. 1, item 3, custom-made, as well as a physical
or legal body under Art. 21, par. 1 and Art. 22, par. 1 is registered under the Trade Law they
shall submit an application for registration to the Executive Director of BDA not later than 14
days after placing the device on the market and/or putting into service on the territory of the
Republic of Bulgaria.
(2) The following documents shall be appended to the registration form under par.1:
1. Valid Entry Certificate in the Trade register;
2. Name and description of the device;
3. Document for paid fee to the amount defined in the rates document under Art. 7, par.1;
(3) The bodies under par.1 and par. 4 are obliged to notify the Executive Director of BDA for
any change in their headquarters address within 14 days. In case of change in the information
under par. 2, item 2 bodies under par. 1 and 4 submit an application under par.1 to the
Executive Director of BDA, to which they enclose the documents regarding the change and a
document for paid fee to the amount defined in the rates document under Art. 7, par.1 .
(4) The manufacturers of devices under par. 1, established on the territory of another member
state or a state from EEA who are not registered for the same devices by the Regulatory
Authorities of this member state or by the Regulatory Authorities of a state of EEA shall
submit an application to BDA appended with documents under par. 2, item 2 and 3 and with a
document for valid registration as a trader according to the national legislation of the relevant
country not later than 14 days after placing the device on the market and/or putting into
service on the territory of the Republic of Bulgaria.

Art. 28 (1) When the manufacturer of devices under Art. 2, par.1, item 1 places on the market
and/or puts into service these devices on the territory of the Republic of Bulgaria and is
registered under the Trade Law, he/she submits an application for registration to the
Executive Director of BDA.
(2) The following documents shall be appended to the registration form under par.1:
  1. Valid Entry Certificate in the Trade Register;
  2. Information about the common technological and/or analytical characteristics referring
      to the reagents, reagent products, control materials and calibrating devices;
  3. In case of devices from list A, list B and self-testing devices - name, type and model of
      the device, analytical and, if necessary, diagnostic features according to the essential
      requirements indicated in regulations under Art.18, results of IVDMD performance
      evaluation.
  4. Instruction for use in Bulgarian;
  5. Document for paid fee defined in the rates document under.Art.7, par.1;


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(3) The manufacturer who places on the market and/or puts into service on the territory of the
Republic of Bulgaria a new IVDMD, when he/she is registered under the Trade Law, shall
submit documents under par.2 to BDA as well as indication that the device is new.
(4) IVDMD is new if on the market of a member state or a state of EEA during the last three
years:
1. such device has not been permanently available for the analyzed substances or other
parameters, or
2. the analytical technology used for the analyzed substances or parameters has not been
available.
(5) Manufacturers of devices under par. 1 and 3, established on the territory of another
member state or a state of EEA, who are not registered for the same devices by Regulatory
Authority of this member state or Regulatory Authority of a state of EEA, shall submit an
application form to BDA, appended with documents under par. 2, item 2 - 5 and with
document for valid registration as a trader according to the national legislation of the relevant
country, after placing the device on the market and/or putting into service on the territory of
the Republic of Bulgaria.
(6) The registration form under par. 1, 3 and 5 shall be submitted within 14 days after the date
of placing on the market and/or putting into service of devices under Art.2, par.1, item 1.
(7) Bodies under par. 1, 3 and 5 are obliged to notify within 14 days the Executive Director of
BDA upon:
1. change in the headquarters address;
2. significant changes in the information under par.2, item 2 and 3;
3. changes in the certificates issued according to the procedures applicable for the device,
according to the relevant regulation under Art. 18 ;
4. withdrawal of the device from the market.

Art. 29 (1) Manufacturer of devices under Art. 27 and 28 and bodies under Art. 21, par. 1 and
Art. 22, par.1 , when established on the territory of other member state or a state of EEA and
registered for the same devices by Regulatory Authority of this member state or Regulatory
Authority of a state of EEA, shall submit notification to BDA within 14 days after placing the
device on the market and/or putting into service on the territory of the Republic of Bulgaria.
(2) When the manufacturers of devices under Art. 27 and 28 and the bodies under Art. 21, par.
1 and Art. 22, par.1 are not established on the territory of another member state or a state of
EEA but are registered for the same devices by Regulatory Authority of this member state or
Regulatory Authority of a state of EEA through authorized body/ bodies, they shall submit
notification to BDA within 14 days after placing the device on the market and/or putting into
service on the territory of the Republic of Bulgaria..
(3) When manufacturer of devices under Art. 27 and 28 and bodies under Art. 21, par. 1 and
Art. 22, par. 1 are not established on the territory of another member state or a state of EEA
but are registered for the same devices by Regulatory Authority and are not registered for the
same devices by Regulatory Authority of this member state or Regulatory Authority of a state
of EEA, they shall authorize bodies registered under the Trade Law, which place these
devices on the market of the Republic of Bulgaria.
(4) The authorized bodies under par. 3 submit to BDA an application for registration under
Art. 27 and 28 .
(5) The authorized body under Art. 3 notifies BDA for any change in its headquarters address.

Art. 30 Manufacturers of devices under Art. 2, par. 1, item 2 and 3 from class IIb or III
submits upon request to BDA information about the name, type, model and class, label and
instructions for use in Bulgarian of the devices put into service on the territory of the Republic


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of Bulgaria.

Art. 31 (1) BDA keeps a register of the medical devices placed on the market and/or put into
service under Art. 27 , 28 and 29 .
(2) The register under par.1 contains:
1. name and address of registration;
2. name, type, class and shelf life of the medical device;
3. name and address of the person who places the medical device on the market and/or puts
them into service;
4. date of removing the medical device from the register and the reason for this;
5. remarks on documented circumstances.
(3) BDA presents registration data for the devices under Art. 27 , 28 and 30 upon request by
the Regulatory Authorities of other member states and by the European Commission.


                                Chapter III
               CLINICAL INVESTIGATION OF MEDICAL DEVICES

                                         Section I
                                     General Provisions

Art. 32 The assessment of the conformity of medical devices under Art. 2, par.1, item 3 with
their specific intended purpose under conditions of use determined by the manufacturer, the
risk assessment regarding the intended purpose of the device, and the risk assessment of an
incident or potential incident, shall be conducted according to clinical data which are based
on:
1. collective scientific data, concerning the intended purpose of the device and critical
analysis of these data, and/or,
2. results from conducted clinical trials.

Art. 33 A clinical trial shall be conducted in a medical institution in accordance with the Law
on Medical Institutions.

Art. 34 (1) Clinical trials on devices under Art. 32 shall be conducted in compliance with the
basic principles for the protection of human rights, safety and human dignity according to the
Declaration of Helsinki for the ethical principles of clinical trials with human subjects.
(2) The rights, safety, and health of the subjects in the clinical test shall be placed above the
interests of science and society.
(3) Clinical trials shall be conducted provided that the estimated benefits for the subject and
the society justify the risks.
(4) The study is planned in a manner that pain, inconvenience, fear, and other disease-
associated foreseeable risks are minimized and the risk threshold and physical pain degree
have been determined in advance and shall be incessantly controlled throughout the clinical
test;
(5) No financial or other incentives shall be given except compensations (travel and daily
costs).

Art. 35 (1) The clinical study shall include a sufficient number of inspections to ensure the
scientific reliability of the conclusions.



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(2) The procedures for conducting the clinical study shall be appropriate for the tested device.
(3) The clinical study is conducted in conditions similar to the normal conditions for intended
purpose.
(4) The clinical study shall encompass all characteristics of the device regarding its safety,
operation, and effect on the subjects.

Art. 36 (1) The whole information from a clinical test shall be recorded and kept in a manner
ensuring its accurate reporting, interpretation, and confirmation. Personal data of the subjects
in the clinical trial shall be stored according to the Personal Data Protection Act.
(2) The documentation under par. 1 shall be stored by the Principal or Coordinating
Investigator for a term of 20 years after the end date of the clinical trial and shall be presented
on request to the relevant Ethics Committee and to BDA.

Art. 37 (1) A clinical test with devices under Art. 32 shall only be allowed on a person who
has:
1. been preliminary presented with written information about the essence, importance,
consequences and potential risks of the study and informed in a conversation with a physician
or dental physician – member of the study team, on the purposes, risks and inconveniences of
the study and on the conditions at which it is to be conducted;
2. been informed on his/her right to withdraw from the study at any time without this having
any negative consequences for him/her;
3. personally given written informed consent to participate.
(2) Where the person cannot write the informed consent to participate in the clinical test the
consent may be given by word of mouth in the presence of one independent witness. The
witness shall certify in writing that this subject has expressed informed consent to participate
in the clinical test in person.
(3) The informed consent pursuant to par. 1, item 3, and par. 2 can only be given by a capable
person who understands the essence, importance, scope, consequences, and eventual risks of
the clinical test. Informed consent to participate in a clinical test can be withdrawn at any time
without negative consequences for the person.
(4) Clinical study of partially capable majors shall be conducted after obtaining written
informed consent by the person and their legal representative. A partially capable person is
presented with information under par. 1, item 1 in accordance with their ability to understand.
The express will of the person to withdraw at any time from the clinical test must be taken
into consideration by the investigator or, in case of necessity, by the principal investigator.
(5) The informed consent of an incapable major person shall be given by his/her legal
representative.
(6) In cases of Art. 162, par. 3 of the Health Act , the informed consent shall be given by a
person assigned by the court.

Art. 38 (1) A clinical test on a minor person shall be conducted after obtaining written
informed consent by both subject’s parents or guardians in compliance with Art. 37, par. 1,
item 1 and 2 and par. 3. Where one of the parents is unknown, deceased, or deprived of
parental rights or such rights have not been delegated in case of divorce, the written informed
consent shall be given by the parent who is exercising the parental rights.
 (2) A clinical test in an underage person shall be conducted after obtaining written informed
consent by both subject’s parents or guardians in compliance with Art. 37, par. 1, item 1 and 2
and par. 3. Where one of the parents is unknown, deceased, or deprived of parental rights or


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such rights have not been delegated in case of divorce, the written informed consent shall be
given by the parent who is exercising the parental rights.
(3) The minor or underage person shall be provided information about the essence,
importance, consequences and eventual risks and benefits of the clinical test in a manner
understandable for that person by a pediatrician or children’s psychologist. .
(4) Parents’ or guardians’ consent must represent the supposed will of the minor person and
can be withdrawn at any time without negative consequences for the minor person.
(5) The underage’s, parents’ and guardians’ consent can be withdrawn at any time without
negative consequences for them.

Art. 39 The decision to participate in a clinical study of a minor, underage, incapable or
partially capable major who is not able to take urgent informed consent by parents or
respectively by the guardian and when the direct purpose is his/her life saving, shall be taken
by at least two physicians, independent from the assignor and from the principal and
coordinating investigator.

Art. 40 (1) A clinical study on pregnant women can be conducted in compliance with the
requirements under Art. 37 only in cases when there are no other alternative proven methods
for diagnostics or treatment and when it does not threaten the pregnant woman’s life and
health and the fetus vitality.
(2) The decision to participate in a clinical study in cases under par. 1 is taken by a committee
of physicians, independent from the assignor and the principal and coordinating investigator.

Art. 41 (1) In the course of the clinical trial the subject shall receive on request additional
information by a person independent from the assignor.
(2) The written information presented to the subject in the trial contains contact data of the
independent person under par.1.

Art. 42 (1) Upon conducting one-site or multi-centre clinical trial on the territory of the
Republic of Bulgaria, when the assignor is not established on the territory of EU or EEA,
he/she authorizes their representative established on the Republic of Bulgaria.
(2) Upon conducting multi-centre clinical study on the territory of the Republic of Bulgaria,
other member state, state from EEA and/or third country, when the assignor is not established
on the territory of EU, he/she authorizes their representative established on the territory of a
state from EU or EEA.
(3) The authorized representative under par. 1 and par. 2 holds the responsibility for
conducting the clinical trial on the territory of the Republic of Bulgaria according to the acting
legislation.
(4) A clinical test shall be conducted under the leadership of an investigator who is:
1. a medical doctor or a doctor of dental medicine with acknowledged medical specialty in the
field of device application and is specially trained to work with the investigational device;
2. familiar with the methodology and requirements for conducting clinical trial;
3. familiar with the principles and requirements for obtaining an informed consent with the
available preclinical and/or clinical data about the product and the study risks and procedures.
(5) The study team shall have relevant qualification and experience and shall pass special
training for performing the study related tasks.
(6) Control on clinical trial is conducted by the assigner or his/her legal representative or a
person assigned by him - observer.
(7) In the course of the clinical trial a physician, respectively dental physician, monitors the


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health condition of the subject and if needed, undertakes relevant medical care.

Art. 43 Planning, conducting, control and clinical results reporting, as well as the obligations
of the assignor, the principal or coordinating investigator and the observer shall comply with
the requirements of this law and the standards ISO 14 155-1 and ISO 14 155-2.

Art. 44 (1) The assignor and principal or coordinating investigator shall make insurance
covering their liability for material and non-material damages to the study subjects.
(2) The contracting authority shall be responsible in case of injury of the health or death
caused by or in the occasion of the conduct of the clinical test where the clinical test has been
conducted in compliance with the requirements and procedures of the study protocol as
approved by the ethics committee.
(3) The principal investigator shall be responsible in case of health damage or death caused by
or in the occasion of the conduct of the clinical trial where the clinical trial has not been
conducted in compliance with the requirements and procedures of the study protocol as
approved by the ethics committee.

                                      Section II
                          Approval To Conduct Clinical Trials

Art. 45 (1) Clinical trials of medical devices under Art. 2, par.1, item 3 from class III, of
implantable medical devices and invasive medical devices for long-term use under Art. 2,
par.1, item 3 from class IIа or IIb and of devices under Art. 2, par.1, item 2, which take place
on the territory of the Republic of Bulgaria can commence upon receiving a positive stand by
the Multi-centre Ethics Committee (MCEC) or by the Local Ethics Committees (LECs), and
an approval by the Executive Director of the Bulgarian Drug Agency (BDA).
(2) Clinical trials of medical devices different from stated under par.1 which take place on the
territory of the Republic of Bulgaria can commence upon notification to the Executive
Director of BDA, if the relevant EC has given a positive stand.
(3) Rules under par. 1 and par. 2 are applicable also for medical devices with applied “CЕ"
marking when clinical trials are conducted with the purpose of change in their designation.

Art. 46 The sponsor or the Principal Investigator (PI) or Coordinating Investigator (CI) can
submit an application form for notification or approval for conducting a clinical trial to the
relevant EC and to BDA simultaneously or consequently.

Art. 47 (1) In the case of multi-centre clinical trial on the territory of the Republic of Bulgaria
persons under Art. 46 submit an application form to the MCEC.
(2) In the case of one-site clinical trial on the territory of the Republic of Bulgaria persons
under Art. 46 submit an application form to the MCEC or to the relevant LEC.

Art. 48 (1) In order to obtain a stand by the relevant EC, the principal, respectively the
coordinating, investigator or the assigner presents:
   1. Administrative documents;
   2. Information about the subject;
   3. Documentation on the study protocol;
   4. Documentation on the investigated medical device;
   5. Documentation about the technical specifications of the site and qualifications of the
       personnel;



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    6. Data on the financing and administrative organization of the study.
(2) The content of documentation under par. 1 is defined in a regulation of the Minister of
Health.
(3) When the EC establishes that documentation under par. 1 is incomplete it notifies the
applicant within 14 days and gives them a deadline for completing the documentation.
(4) Within 30 days after submission of the valid documentation EC passes a stand which is
presented to BDA and the applicant.

Art. 49 (1) When the stand of the EC under Art. 48 is negative, the applicant can appeal
before the Central Ethics Committee (CEC) established under LMPHM within 14 days since
the date of notification.
(2) CEC passes a stand within 14 days after the date of written request by the applicant.
(3) The opinion of the Central Ethics Committee shall be final and binding on the respective
ethics committee.

Art. 50 (1) In order to get an approval for clinical trials under Art. 45, par. 1, the applicant
submits an application form to BDA.
(2) The application form under par. 1 shall be submitted not later than 60 days before the start
date of the trial and the following documentation shall be appended to it:
   1. Identification data for the medical device on paper and CD;
   2. Clinical trial design which describes the purpose, scientific, technical and medical
       rationale for conducting the trial, its scope, methodology and organization of the trial
       and the number of devices;
   3. the names of the investigators, of principal investigator(s) or coordinating investigator,
       as well as the name and address of the medical institutions where the trial is to be
       conducted;
   4. Start date, final date and schedule of the clinical study when the applicant has submitted
       applications consequently under Art. 46;
   5. Positive stand by the EC in case that the applicant has submitted the application to EC
       and BDA consequently;
   6. Declaration that the medical device complies with all relevant essential requirements
       excluding those which are object of clinical trial, and that all expected safety measures
       have been taken to ensure the safety and health of the subjects in the trial and of the
       investigating team;
   7. Insurance policy covering the responsibility of the sponsor and the investigator for
       causing material and non-material damages to the subjects in the trial during and as a
       result of conducting a clinical study;
   8. Agreement template between the sponsor and the site;
   9. Document for paid fee to the amount defined in a rate document under Art.7, par.1;
(3) Upon simultaneous submission under Art. 46, the applicant can present its stand under par.
2, item 5 after its obtaining, but not later than the term defined under Art. 51, par.1.
(4) The applicant guarantees that the documentation submitted to BDA and to EC is identical.

Art. 51 (1) BDA assesses the submitted documents under Art. 50 within 60-days after its
submission.
(2) BDA can request additional information regarding the documents under Art. 50, par.2.
(3) In cases under par.2, the 60-day term shall cease to run until the submission of the
requested documentation.
(4) Within the period under par.1, the Executive Director of BDA shall notify in writing the
applicant that:


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1. they issue an approval for the conduct of the clinical trial or,
2. the trial cannot be conducted, as they state the reasons for refusal.
(5) In cases under par.4, item 2, within 30 days after the date of notification, the applicant can
submit to BDA an application amended in accordance with the stated reasons for refusal to
conduct the clinical trial.
(6) Within 30 days after the date of submission of the amended application under par. 5 BDA
notifies the applicant in writing that:
1. they approve the conduct of the clinical trial, or
2. the trial cannot be conducted, stating the reasons for refusal.
(7) Transcript of the approval for conduct of the clinical trial is sent to the medical institution
indicated in the application under Art. 50, par.1 .
(8) In case of missing statement within the period defined under par. 1, the applicant can start
the trial immediately.

Art. 52 (1) The Executive director of BDA passes a motivated refusal for conduct of clinical
trial on the territory of the Republic of Bulgaria when:
1. there is insufficient evidence for the expected scientific and medical benefits from the use
of the medical device;
2. there is insufficient evidence for the safety of the subjects in the trial and/or the investigator
team;
3. presented information for assessing the safety of the clinical trial is not enough;
4. the operation of the device does not comply with its intended use defined by the
manufacturer;
(2) The refusal under par.1 shall be subject to appeal under the terms of the Administrative
Procedure Code.
(3) In the case of a multi-centre trial BDA notifies the regulatory authorities of other countries
on the refusal under par. 1 and presents its reasons for this.

Art. 53 (1) The applicant can at any time make amendments in the study protocol different
from the essential amendments.
(2) In cases under par. 1 the applicant shall keep the documentation relating to the
amendments and shall provide it to the BDA and the ethics committee upon request.
Art. 54 (1) The applicant can implement planned study substantial protocol and
documentation amendments.
(2) In cases under par.1, the applicant submits an application form appended with the
documents regarding the amendments, to the relevant EC and to BDA.
(3) The EC passes a stand within 15 days after receiving the application under par.2 and
presents it to the assignor and BDA.
(4) Within 15 days after the date of receiving the stand by the relevant EC, the Executive
Director of BDA:
1. issues an amendment to the approval for conduct of clinical trial, approving the change in
the study protocol, or
2. gives a motivated refusal for the substantial amendment under par.1.
(5) The refusal under par. 4, item 2 shall not be subject to appeal.
(6) If within the term under par.4 the applicant does not receive a refusal by BDA, he/she can
conduct the clinical trial according to the changed protocol.

Art. 55 (1) Upon new circumstances which can threaten the safety of the subjects of the
clinical trial in the course of its conduct, the assignor and the investigator undertake emergent


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measures to ensure subjects’ protection from the occurred risks.
(2) In cases under par.1, the assignor can make amendments in the clinical protocol.
(3) The assignor shall inform immediately the relevant EC and BDA about the measures
undertaken, about the reasons for them and the amendments in the protocol.

Art. 56 (1) The assignor of the clinical trial is obliged to present to BDA on request technical
documentation containing:
1.design plans, production methods, regarding also sterilization, charts of components and
parts, ways of connection and others;
2. description and explanation of the charts and plans and the operation of the medical device;
3. results from risk analysis and a list of applicable totally or partially standards under Art. 13,
par. 1 and description of received technical decisions for ensuring essential requirements
conformity, when standards are not applicable or are partially applicable;
4. results from design calculations and conducted inspections and technical tests.
(2) The assignor of the clinical trial is obliged to store the technical documentation for 10
years after termination of the clinical trial – for devices under Art. 2, par. 1, item 2, and 5
years – for devices under Art. 2, par.1, item 1 and 3 .
(3) The manufacturer is obliged to ensure a production process whereby the medical devices
intended for clinical trials are produced in accordance with the technical documentation.

Art. 57 (1) Within 90 days after termination of the clinical trial, the assignor presents to BDA
and the relevant EC a final report which contains description of methodology and
organization, critical assessment and statistical analysis of received data.
(2) The report under par. 1 shall be signed by the assignor and by all investigators. When one
of the investigators refuses to sign it, he/she shall attach his/her reasons in writing.
(3) The report under par. 1 shall summarize data received from all medical institutions and
from all subjects in the trial.
(4) Personal data of the subjects of the trial which are included in the report under par.1 shall
be coded.

Art. 58 (1) BDA keeps a register of the issued and withdrawn authorizations for conducting
of a clinical trial.
(2) BDA organizes and establishes a system for registration, analysis and summary of all
incidents with medical devices that have occurred in the course of clinical trials.
(3) The pharmacovigilance procedure for medical devices in the course of the clinical trial is
determined in the regulation under Art. 48, par.2.

Art. 59 (1) The Executive Director of BDA can issue, with an order, a temporary ban on
conducting the trial or terminate it provided that:
1. the trial is conducted under conditions different from stated in the authorization;
2. there is information about violating the scientific authenticity of the trial;
3. there is a risk for the subject safety.
(2) Before undertaking any actions under par.1, BDA notifies for their intentions:
1. the assignor and coordinating investigator, responsible for conducting the trial at all sites,
or,
2. the assignor and principal investigator, who is in charge of the relevant medical institution
where the trial shall be terminated.
(3) Within 7 days after notification under par. 2 the assignor and the principal and
coordinating investigator can present written explanations to BDA.
(4) Par. 2 does not apply if there is an immediate risk for the health and safety of the subjects


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in the trial.
(5) The ordinance under par. 1 can be subject to appeal under the terms of the Administrative
Procedure Code when the appeal does not stop its enforcement.
(6) The principal or coordinating investigator notifies the subjects of the clinical trial on the
ordinance under par. 1.

Art. 60 In cases under Art. 59, par. 1 the Executive Director of BDA notifies immediately:
1. the regulatory authorities of the member states;
2. the relevant ethics committees;
3. the European Commission.


                                      Chapter Four
                                    NOTIFIED BODIES

Art. 61 (1) Approval for conformity assessment of medical devices is issued to a physical or
legal person registered under the Trade Law by the Chairperson of the State Agency for
Metrology and Technical Surveillance (SAMTS).
(2) The person under par. 1 submits a written application to SAMTS specifying the devices
and procedures for which he/she applies .
(3) The application under par. 2 shall be appended by:
1. a certificate under Art. 33 of the Law on Trade Register in case the person is registered
under the Trade Law or a copy of the Establishment Act in case the person is established
according to a law or an act of the Council of Ministers;
2. a certificate that the person has not declared insolvency or is not in process of declaring
insolvency;
3. documents certifying that the person does not have liabilities to the state or the municipality
regarding the Tax and Social Insurance Procedure Code, established by enforced act of
Competent Authority, or liabilities to Insurance funds, unless the Competent Authority has
permitted extension or reprieve of the liabilities;
4.a copy of labour and/or civil agreements of the personnel, education documents,
additionally acquired qualification;
5. a copy of agreement when the person participates in unions of Trade Associations and
Organizations;
6. a copy of agreements with subcontractors, when trials and investigations are assigned to
other people;
7. a copy of insurance agreement which covers risks upon obligations performance in the
course of conformity assessment activities;
8. a declaration that the person, personnel and subcontractors have not taken part in design,
production, delivery and installation of the devices, which will be assessed, as well as that
they are not authorized representatives or manufacturer consultants;
9. a copy of documented procedures for conformity assessment procedure, which he/she
applies for;
10. an equity declaration which ensures that the personnel obligations performance is not
influenced by moral pressure and financial incentives by people interested in the assessment
results;
11. a declaration that the personnel is bound with the requirement for professional secret
protection regarding the information he/she obtains in the course of activity performance;
12. data for the personnel and subcontractors professional experience, if any, which prove
medical and technical competency and gained experience at assessment of devices stated in


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the application according to the applicable procedures, including experience at drawing up
reports, protocols and certificates;
13. information about the technical devices needed for the conducting of trials and
investigations which are part of the procedures for conformity assessment and which are
available at their own testing laboratories and/or contracted testing laboratories, and copies of
accreditation assessments of the laboratories, if any;
14. a list of the standards under Art. 13, par. 1 or monographs of the official pharmacopoeia in
the Republic of Bulgaria under Art. 13, par. 2 , or general technical specifications under Art.
13, par. 3, regarding the devices specified in the application;
15. methods and instructions for device trial in case the standards under Art. 13, par.1 or
monographs of the official pharmacopoeia in the Republic of Bulgaria under Art. 13, par.2 ,
or the general technical specifications under Art. 13, par.3 ;
16. copies of documents certifying their education, audit training, professional and audit
experience according to the requirements of BDS EN ISO 19011 of the auditor who will
perform the assessment of the implemented quality system when required by the conformity
assessment procedure.
17. quality system manual and procedures;
18. document for paid fee for documentation assessment to the amount defined under Art. 7,
par.1.
(4) When the person applying for authorization for conformity assessment presents an
accreditation certificate according to standards indicated in the regulation under Art.18, it is
accepted that he/she has a functional quality system referring to the requirements for
independence, equity, confidentiality and has the needed competence. In this case the person
does not present the documents under par. 3, item 8, 10, 11 and 17.

Art. 62 (1) The Chairperson of the State Agency for Metrology and Technical Surveillance
designates by an order a commission of experts to assess the presented documents under Art.
61, par. 3 or 4 .
(2) The commission under par.1 consists of representatives of the State Agency for Metrology
and Technical Surveillance, designated by its chairperson, and of BDA, designated by its
Executive Director.
(3) If necessary, outside experts with experience and knowledge in the field of the relevant
devices can bе gained to the commission under par. 1.
(4) When there are non-conformities and incomplete issues in relation to the documentation
under par. 1, the Chairperson of the State Agency for Metrology and Technical Surveillance
presents a to the applicant a copy of the expert assessment of the commission under par. 1 and
sets a two-month term for their removing. The timeline under Art. 63, par. 5 ceases to run
until removing the non-conformities and incompleteness.
(5) When the applicant does not remove the non-conformities and missing issues within the
term under Art. 4, the procedure is ceased.

Art. 63 (1) Within a two-month period after the date of submission of the valid
documentation under Art. 61, par. 3 or 4, the commission under Art. 62, par.1 conducts an on-
site inspection to establish the competency of the applicant and his/her abilities to perform the
declared conformity assessment procedures. To perform an on-site inspection a fee to the
amount defined in the fee documents under Art. 7, par. 1 shall be paid.
(2) When upon an on-site inspection non-conformities between presented documentation
under Art. 61, par. 3 or 4 and the requirements for conformity assessment defined in
regulations under Art.18 are established, the Chairperson of the State Agency for Metrology
and Technical Surveillance notifies the applicant in writing and sets a two-month period for


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their removing. The timelines under par. 5 cease to run until removing the non-conformities.
(3) When the applicant doe not remove the established non-conformities within the two-
month term defined under par.2, the Chairperson of the State Agency for Metrology and
Technical Surveillance with a motivated order refuses to issue an authorization.
(4) Within two months after the on-site inspection, the commission under par.1 passes a stand
to the Chairperson of the State Agency for Metrology and Technical Surveillance with a
motivated proposal for approval for notification or for refusal.
(5) Within six-month term after submission of the documents under Art.61, par.3 or 4 the
Chairperson of the State Agency for Metrology and Technical Surveillance notifies the
applicant that he/she is approved for notification or issues a motivated order for refusal.

Art. 64 (1) Within three days after notification under Art. 63, par.5, the Chairperson of the
State Agency for Metrology and Technical Surveillance declares to the European Committee
and the member states the approved bodies under Art. 61, par.1.
(2) The identification number of the bodies under par.1, called "notified bodies", is
determined by the European Committee.
(3) The Chairperson of the State Agency for Metrology and Technical Surveillance issues to
the notified body under par.2 an authorization for conformity assessment performance.
(4) The name and the address of the body under par. 2, medical devices and conformity
assessment procedures are published in the Official Journal of the EU.

Art. 65 The conformity assessment procedures can be performed by conformity assessment
bodies declared to the European Commission by other member states.

Art. 66 The authorization for conformity assessment performance contains:
1. name of the body that has issued the authorization;
2. name, headquarters, business address and agency of the notified body;
3. medical devices and conformity assessment procedures;
4. date of authorization issue;
5. identification number of the notified body under Art.64 , par.2 .

Art. 67 (1) In the register under Art. 19 from the Law on technical requirements for products
the following shall be specified:
1. data under Art. 66 ;
2. date of authorization suspension and the reason for it.
(2) Data under par. 1 is published in the official bulletin of the State Agency for Metrology
and Technical Surveillance.

Art. 68 (1) The notified bodies are obliged to notify the Chairperson of the State Agency for
Metrology and Technical Surveillance upon:
1. changes in the legal and accreditation status, structure, scope of activity and conformity
assessment procedures;
2. changes in the quality system, management or personnel who have influence on the
performance of the conformity assessment procedures;
3. change of the subcontractors;
4. changes in the circumstances regarding the insurance under Art. 61, par. 3, item 7 .
(2) The bodies under par.1 submit to the Chairperson of the State Agency for Metrology and
Technical Surveillance the documents regarding the changes and a fee to the amount defined
under Art.7, par.1.
(3)Within one month after submission of the documents under par.2, the committee of experts


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under Art. 62, par.1 passes a stand to the Chairperson of the State Agency for Metrology and
Technical Surveillance for approving the changes.
(4) In cases when changes under par. 1 require an on-site inspection, the committee under Art.
62, par. 1 passes a stand to the Chairperson of the State Agency for Metrology and Technical
Surveillance for approving the changes within a two-month period.
(5) On the grounds of the stand under par. 3 and par.4, the Chairperson of the State Agency
for Metrology and Technical Surveillance issues with an order an amendment to the
authorization under Art. 64, par.3 .
(6) When upon inspection of the documentation under par. 2 or upon on-site inspection non-
conformities and incomplete issues regarding the requirements of regulation under Art.18 are
found, the committee under Art. 62, par.1 gives instructions with a deadline for their
removing. The timelines under par. 3 and 4 cease to run until implementing the instructions.
(7) When the notified bodies do not implement the instructions under par.6, the Chairperson
of the State Agency for Metrology and Technical Surveillance with an order refuses to issue
an amendment to the authorization.

Art. 69 For widening the scope of authorization for conformity assessment performance an
application form under Art. 61 shall be submitted.

Art. 70 (1) The notified bodies are obliged to present to the State Agency for Metrology and
Technical Surveillance an annual report for their activity which includes information for
conducted conformity assessments of medical devices, claims, complaints and taken
measures for their solving with deadline 31 January of the year to come.
(2) A copy of the report under par.1 shall be presented to the Executive Director of BDA.

Art. 71 (1) Upon the annual planned inspections, commissions designated with an order by
the Chairperson of the State Agency for Metrology and Technical Surveillance control the
performance of conformity assessment procedures.
(2) Special on-site inspections by the notified bodies can be performed upon receiving signals,
claims and complaints regarding their activity.
(3) When during inspections some gaps in the work of the notified bodies are established, the
Chairperson of the State Agency for Metrology and Technical Surveillance issues instructions
with a deadline for removing the gaps.
(4) The Chairperson of the State Agency for Metrology and Technical Surveillance issues an
order for temporary ban on the activity of the notified bodies until removing the gaps under
par. 3. A copy of the order shall be sent to BDA.

Art. 72 (1) The Chairperson of the State Agency for Metrology and Technical Surveillance
with an order withdraws the authorization for conformity assessment when during inspections
it has been established that the notified body:
1. has ceased to comply with some of the conditions under which the authorization has been
issued;
2. is not able to proceed with the performance of the conformity assessment procedures;
3. does not conduct the conformity procedures according to the requirements of the relevant
regulation under Art. 18 ;
4. has not taken measures for removing the gaps under Art. 71, par.3 within the set term.
(2) A copy of the order under par. 1 shall be sent to BDA.

Art. 73 The Chairperson of the State Agency for Metrology and Technical Surveillance
notifies the European Commission and member states for the withdrawn authorizations under


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Art. 72 and for the accomplished changes under Art. 68, par.1, item 1 .

Art. 74 (1) The person who has been refused the issuing of an authorization under Art. 63,
par.5, can submit a new application for authorization not earlier than 6 months after the date
of handing the order for refusal.
(2) The notified body who has been revoked an authorization under Art. 72, par.1 can submit
an application for new authorization not earlier than one year after the date of handling the
order for authorization withdrawal.

Art. 75 The refusal for issuing an authorization for conformity assessment performance as
well as the order for authorization withdrawal can be subject to appeal under the terms of the
Administrative procedure code.

Art. 76 (1) The notified body issues a certificate validating the essential requirements
conformity applicable for the device, with validity of 5 years, or makes a motivated refusal.
(2) When the notified body establishes that the manufacturer does not comply with the
requirements defined in the regulations under Art.18 , after evaluating the risk for device
safety, he/she can restrict the scope of the certificate, suspend its validity temporarily or
withdraw it.
(3) The notified bodies are obliged to present to the State Agency for Metrology and
Technical Surveillance and to BDA:
1. a copy of all issued certificates, information for refused certificates and certificates whose
validity is temporarily suspended, or withdrawn certificates – on every three months;
2. additional information and necessary documentation regarding the activities for conformity
assessment- on request.
(4) The notified bodies are obliged on request to present information under par. 3, item 1 to
the other notified bodies from the member states.

                                 Chapter Five
                     WHOLESALE TRADE IN MEDICAL DEVICES
Art. 77 Wholesale trade in medical devices on the territory of the Republic of Bulgaria may
be performed by physical or legal persons who are registered as traders under the national
legislation of a member state or a state of the European Economic Are and have a license for
such an activity issued by a regulatory authority of the relevant state.

Art. 78 (1) The persons under Art.77 willing to be given authorization or certificate for
wholesale trade in medical devices shall submit to BDA an application form approved by
BDA Executive Director, to which the following documents shall be appended:
1. a certificate under Art.33 of the Trade Register Act, or any relevant document under the
national legislation of the relevant member state or state of the European Economic Area.
2. a list of the medical devices on paper and magnetic bearer;
3. a document for paid fee to the amount defined in the tariff under Art.7, par.1.
(2) In case they have available premises for storage and wholesale trade in medical devices on
the territory of the Republic of Bulgaria, the persons under par.1 specify in the application
form their address as well. In this case the following documents are also appended to the
documentation under par.1:
1. a certificate for putting into operation of the premises, issued under the Territory Layout
Act;



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2. a document certifying the legal grounds for using the premises;
3. a declaration drawn up by the persons under par.1, stating that:
а) the premises conform to the conditions for storage and wholesale trade in medical devices,
specified in the list under par.1, item 2, according to their specificity and the manufacturer’s
instructions defined in the instructions for use, and,
b) they own or have available means of transport ensuring their proper storage upon
distribution or transporting;
4. name, permanent address and correspondence address of the person designated to be in
charge of the premises for storage and wholesale trade in medical devices, as well as a copy
of the contract on the basis of which this person has legal relationship with the applicant.
(3) The persons under Art.77 who have a registration certificate or an authorization for
wholesale trade in medical devices issued by a regulatory authority of another member state
or a state of the European Economic Area, shall present/submit to BDA:
1. a copy of the authorization or certificate for wholesale trade, legalized by a notary in the
member state, accompanied by legalized translation in Bulgarian;
2. the documentation pursuant to par.1, item 2 and 3.
(4) In case the persons under par.3 have available premises for storage and wholesale trade in
medical devices on the territory of Bulgaria they shall in addition submit to BDA the
documentation under par.2.
(5) In case the persons under par.3 do have available premises for storage and wholesale trade
in medical devices on the territory of Bulgaria they shall also submit to BDA name and
correspondence address of their representative authorized in the country.

Art. 79 (1) The Bulgarian Drug Agency reviews the submitted documentation pursuant to
Art. 78.
(2) In case of ascertaining imperfections in the documentation under par.1, BDA shall notify
the applicant in writing on their elimination. Until submission of valid documentation, the
time limit under par.3 shall cease to run as of the notification date.
(3) Within 30 days after the submission of valid documentation, The Executive Director of
BDA issues:
1. a certificate for wholesale trade in medical devices to the persons under Art. 78, par.3.
2. authorization for wholesale trade in medical devices to persons other than specified in item
1.

Art. 80 (1) Wholesale traders in medical devices shall submit to BDA an application form for
amendment and/or addition, in case of change regarding:
1. address of the premises for storage and wholesale trade in medical devices in the cases
pursuant to Art. 78, par. 2 and 4;
2. the person under Art. 78, par. 2, item 4 and/or their address;
3. the trader’s legal statute, headquarters and/or business address;
4. the list of types of medical devices traded in;
5. the name and/or address of the authorized representative under Art. 78, par. 5.
(2) The documents relating to the change shall also be appended to the application form under
par. 1.
(3) The certificate or authorization for amendment is issued by the Executive Director of
BDA within 15 days after submission of application form under par. 1. In case of change in
the address of the premises for storage and wholesale trade in medical devices the term shall
be prolonged by 15 days.
(4) The persons under par. 1 are obliged, within 10 days after termination of their activities
relating to wholesale trade in medical devices, to notify in writing the Executive Director of


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BDA.
(5) In the cases under par. 4 the Executive Director of BDA shall terminate with an ordinance
the effect of the issued authorization or invalidate the issued certificate for wholesale trade.

Art. 81 The Bulgarian Drug Agency keeps a register of the issued certificates or
authorizations for wholesale trade in medical devices which contains:
1. number and date of the certificates or authorizations for wholesale trade in medical devices;
2. name, headquarters and business address of the persons under Art. 77;
3. date of termination of authorizations or certificates under item 1;
4. address of the premises for storage and wholesale trade in medical devices;
5. name and address of the persons under Art. 78, par. 2, item 4;
6. name and address of the persons under Art. 78, par. 5.

Art. 82 (1) The wholesale traders in medical devices are obliged to trade only in medical
devices the shelf life of which has not expired and which have:
1. affixed CE marking in compliance with the requirements under Art. 15;
2. affixed identification number of the notified body under Art. 64, par. 2, provided that such
a body has participated in the conformity assessment;
3. affixed name and business address of the manufacturer and/or their authorized
representative and the importer;
4. instructions for use, except for devices that the Act do not provide for.
(2) The persons under par. 1 are obliged to maintain the premises under Art. 78, par. 2 in
accordance with the requirements for storage of the relevant type of device, defined by the
manufacturer
(3) The persons under par. 1 shall keep report on:
1. the quantity bought and sold in terms of types of devices, the purchase and sale date, the
name and address of the wholesale traders or the sites under Art. 83, par. 1, items 2-4, that
they have done business with;
2. the warehouse availability of medical devices, the batch number and shelf life.
(4) The persons under par. 1 provide and maintain a documented system for tracing the safety
of medical devices placed on the market and for blocking and withdrawing from the market of
medical devices which have shown non-conformity with the safety requirements within the
meaning of Chapter 7.
(5) Alongside the documentation under par. 3, the batch certificates of medical devices shall
be stored for a period of 5 years and shall be presented on request to the persons under Art.
86Към документацията по ал. 3 се съхраняват партидните сертификати на
медицинските изделия за срок 5 години и се предоставят при поискване на лицата по
чл. 86, ал. 2 .

Art. 83 (1) The wholesale traders may do business transactions with medical devices,
adhering to storage and distribution restrictions, with:
1. other wholesale traders within the meaning of this Act;
2. medical institutions;
3. health institutions;
4. pharmacies and drugstores.
(2) The Minister of Health designates with an ordinance the medical devices which can be
sold at sites other than those listed in par. 1.

Art. 84 (1) The persons under Art. 86, par. 2 shall perform scheduled and unexpected visits at
the premises for storage and wholesale trade in medical devices.


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(2) The persons under par. 1 may require, inspect and copy the documentation under Art. 82,
par. 3 and 4 and take samples and specimens of the devices under the terms of Art. 93, par. 3.
(3) In case the inspection ascertains that medical devices do not meet the requirements of Art.
82, par. 1, item 1, 2 and 3, or that their shelf life has expired, the Executive Director of BDA
terminates temporarily or revokes the authorization, or invalidates the certificate for
wholesale trade and orders that the devices placed on the market and/or put into service shall
be blocked and withdrawn.
(4) Upon ascertaining that the premises for storage and wholesale trade do not conform to the
requirements defined by the manufacturer regarding the specific device, the persons under
par. 1 shall give instructions and set a term for eliminating non-conformities.
(5) In case the inspection ascertains that there are imperfections and inaccuracies in the
documentation under Art. 82, par. 3 or in the system under Art. 82, par. 4, the persons under
par. 1 shall give instructions and set a term for eliminating them.
(6) In case the non-conformities, imperfections and inaccuracies are not eliminated within the
terms under par. 4 and 5, the persons under par. 1 present an opinion to the Executive Director
of BDA, including a proposal to revoke the authorization or to invalidate the certificate for
wholesale trade.
(7) BDA Executive Director’s ordinances under par. 3 and 6 may be appealed against under
the terms of the Administrative Procedure Code, and the appeal shall not terminate their
implementation.

Art. 85 The Bulgarian Drug Agency shall notify the regulatory authorities of member states
on authorizations or certificates for wholesale trade in medical devices that have been issued,
temporary terminated and withdrawn, and the motives for that.

                                     Chapter Six
                                  MARKET CONTROL

Art. 86 (1) Market control is conducted to ensure compliance of the medical devices placed
on the market and/or put into service with the law requirements and the regulations under Art.
18 .
(2) Market control on the territory of the Republic of Bulgaria is conducted by BDA through
inspectors and experts designated with an order by the Executive Director.

Art. 87 (1) Market control is conducted by means of:
1. inspections of devices placed on the market and/or put into service;
2. taking samples and specimens of the devices and their testing.
(2) Trials of medical devices can not be conducted by the notified bodies participating in the
conformity assessment of the same devices.

Art. 88 Inspections of medical devices placed on the market and/or put into service are
conducted according to:
1. previously confirmed annual plan for market control in groups of medical devices,
respectively by the Executive Director of BDA, and
2. signals from other authorities and identified written signals from citizens.

Art. 89 Persons under Art. 86, par. 2 conduct inspections at sites under Art. 83, par. 1, item 2
- 4 and par. 2 , as well as at the production premises of medical devices.

Art. 90 Persons under Art. 86, par. 2 conduct inspections for:


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1. presence of "СЕ" marking and for its conformity with the law requirements;
2. identification number of the notified body under Art. 64, par.2 , when such a body has
taken part in the conformity assessment of the medical device;
3. presence of instructions for use and conformity of its content with the requirements of
regulations under Art.18, excluding the devices under Art. 2, par.1, item 3 which are fall in
class I and class IIа, if they can be safely used without instructions for use;
4. presence of batch or serial number when the relevant regulation under Art. 18 requires such
a number;
5. presence of name and headquarters of manufacturer, or their authorized representative, or
the importer on the medical device;
6. shelf life of the medical device;
7. date on which the device subject to registration under Chapter II is placed on the market
and/or put into service on the territory of the Republic of Bulgaria.

Art. 91 (1) When upon inspection the persons under Art. 86, par.2 establish that the medical
devices are placed on the market and/or put into service without "СЕ" marking or with
expired shelf life, they pass a stand to the Executive Director of BDA with a proposal for
issuing an order for block and recall of the device from the market.
(2) When during inspection the persons under Art. 86, par.2 establish that medical devices are
placed on the market and/or put into service without instructions for use or their content does
not comply with the requirements of regulations under Art. 18, they give instruction to the
manufacturer or his/her authorized representative with a deadline for eliminating the
ascertained breach.
(3) When the breach under par. 2 is not eliminated within the deadline the persons under Art.
86, par. 2 pass a stand to the Executive Director of BDA with a proposal for issuing an order
for block and recall of the device from the market.
(4) When one of the requirements under Art. 90, item 2 and 4 is not fulfilled or the applied
marking does not comply with the requirements under Art. 15 , persons under Art. 86, par. 2
require from the manufacturer or his/her legal representative or from the importer to present
within 10 days:
1. conformity declaration;
2. technical documentation under Art. 14, par.1 .

Art. 92 (1) Persons under Art. 86, par. 2 pass a stand to the Executive Director of BDA who
issues an order for block and ban on the distribution of devices, if within the term under Art.
91, par. 4 the conformity declaration and technical documentation are not presented, except
for the cases when the term under Art. 14, par.3 has expired.
(2) Within 30 days after the date of handling the order under par. 1, the manufacturer, his/her
authorized representative or the importer are obliged to withdraw the device from the market.

Art. 93 (1) When upon inspection of documentation under Art. 91, par. 4 it is established that
the content of conformity declaration does not comply with the content determined by the
regulations under Art. 18 , or after the inspection of the technical documentation doubts occur
that the device does not comply with the essential requirements, persons under Art. 86, par.2
take samples or specimens of the testing device.
(2)The trial is conducted in a laboratory accredited by the Executive Agency "Bulgarian
Accreditation Service" or in laboratory accredited by an authority of a member state or a state
of EEA.
(3) The conditions and the way for taking samples and specimens of medical devices for
testing are determined with a regulation by the Minister of Health and by the Minister of


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Economy and Energetics.
(4) In case of disputing the results of conducted laboratory tests, within 7 days after the date
of receiving the results from the initial test, the manufacturer or his/her authorized
representative presents to BDA a written request for conducting a second test.
(5) The second test under par. 4 is conducted by experts who have not taken part in the initial
test.

Art. 94 (1) In cases under Art. 93 the Executive Director of BDA issues an order for
temporary ban on the distribution or use of the specific device.
(2) Copy of the order under par. 1 is handled to the manufacturer or his/her authorized
representative or the importer.

Art. 95 When persons under Art. 86, par. 2 establish that the nonconformity with the essential
requirements can be corrected, they pass a stand to the Executive Director of BDA and give
instructions with a deadline, approved by the manufacturer or his/her authorized
representative, for conducting the required corrective actions or for complete conformity
assessment of the device with the essential requirements.

Art. 96 (1) When persons under Art. 86, par. 2 establish that the nonconformity with the
essential requirements can not be corrected, they pass a stand to the Executive Director of
BDA.
(2) On the grounds of the stand under par. 1, the Executive Director of BDA issues an order
for block and ban on the distribution or use of the device and arranges its withdrawal from the
market within 30 days after the date of handling the order to the manufacturer or his/her
authorized representative or the importer.
(3) BDA notifies the Regulatory Authority of the member state where the manufacturer or
his/her authorized representative and the importer are established on the order under par. 2.
Art. 97 The orders under Art. 92, par.1 , Art. 94 , Art. 96, par. 2 and Art. 99, par.1 are subject
to appeal under the terms of the Administrative procedure code, provided that the appeal does
not stop their enforcement.

Art. 98 (1) When after the test under Art. 93 it is established that the medical devices do not
comply with the essential requirements, the expenses for taking samples or specimens for
testing are on the account of the manufacturer, his/her authorized representative or the
importer.
(2) When after the test under Art. 93 it is established that the medical devices comply with the
essential requirements, the expenses for taking samples or specimens for testing are on the
account of BDA.

Art. 99 (1) The Minister of Health upon proposal of the Executive Director of BDA can ban
with an order the placing on the market and/or putting into service, limit the scope of
operation or impose additional requirements for placing on the market and/or putting into
service of a device or group of devices, when this is in favor of the public health.
(2) In the cases under par.1 BDA informs the European Commission and Regulatory
Authorities of the member states about the order, the reasons for it and the measures taken.

Art. 100 (1) Persons under Art. 86, par.2 shall be insured at the expense of BDA budget
against an incident which can occur upon or as a result of performance of their work
obligations.
(2) Upon inspections persons under Art.86, par.2 can ask for cooperation the Regional


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Inspectorate of Public Health Protection and Control, the bodies of the Ministry of Inferior
and the Competent Authorities of local self-government.

Art. 101 BDA publishes on its web site information about the devices for which there is an
issued order under Art. 91, par.1 , Art. 92, par.1 , Art. 94 and Art. 96, par. 2.

Art. 102 Persons under Art. 86, par.2 are obliged:
1. not to spread facts and circumstances they became familiar with during or regarding their
work duties.
2. to use received documents and information only for the purposes of market control;
3. to produce their identity papers during inspections.

                            Chapter Seven
          INCIDENTS NOTIFICATION AND EVALUATION SYSTEM

Art. 103 (1) The manufacturer is obliged to create and maintain a documented system for
tracing the safety of medical devices manufactured by them and placed on the market/put into
service on the territory of member states, of states from the European Economic Area and
third countries, as well as to have at their disposal the mechanisms for implementing the
necessary corrective actions.
(2) The system under par. 1 shall be applied for medical devices that:
1. have CE marking;
2. do not have CE marking in case the incident or the potential incident relating to them under
Art. 106, par. 1 and 2 necessitates performance of corrective actions applicable to devices
under item 1.
(3) The system shall not apply to devices intended for clinical trials and devices for operation
assessment.
(4) The system under par. 1 includes examination of safety of devices under par. 2 that have
been placed on the market and/or put into service by way of:
1. collecting, documenting and analyzing reports for events under Art. by medical specialists,
patients, persons installing, maintaining and calibrating the devices, and BDA;
2. analysis of results from additional tests on the devices performed by the manufacturer;
3. collecting, documenting and analyzing data from scientific literature.

Art. 104 Physicians, dental physicians and other medical specialists, and persons installing,
maintaining and calibrating the devices are obliged to inform immediately the manufacturer
or BDA about events under Art. 105 at the sites under Art. 83, par. 1, item 2 and 3.

Art. 105 (1) The manufacturer shall notify BDA on any fault or deterioration in the
characteristics of the device manufactured by him/her, and/or in its operation, as well as on
incomplete or inaccurate information on its label or instructions for use, which has caused
death or serious health damage, or could cause death or serious health damage to a patient,
medical specialist or third persons on the territory of the Republic of Bulgaria.
(2) The manufacturer shall also notify BDA on any technical or medical cause relating to the
device characteristics or operation, which, due to reasons specified in par. 1, leads to regular
withdrawal from the market of the same type of devices.

Чл. 106. (1) The manufacturer shall submit to BDA a preliminary report within 10 days of
receipt of information about an event under Art. 105 which has caused death or serious health
damage, and hereafter referred to as incident.


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(2) The manufacturer shall submit to BDA a preliminary report within 30 days of receipt of
information about an event under Art. 105 which could have caused death or serious health
damage that were averted by a favourable circumstance or medical intervention, and hereafter
referred to as potential incident.
(3) In case the incident or potential incident concerns devices of class IIa, Iib or III, or in vitro
diagnostic medical devices from List A and List B, or self-testing devices, and has occurred in
a third state, the manufacturer shall submit to BDA, within the term under par. 1 or 2, a
preliminary report in the cases when a notified body under Art. 64, par. 2 has performed
conformity assessment on the device connected with the incident.
(4) In case the incident or potential incident concerns devices of class I or in vitro diagnostic
medical devices that are not from List A and List B and are not for self-testing, and has
occurred in a third state, the manufacturer shall submit to BDA, within the term under par. 1
or 2, a preliminary report in the cases when the manufacturer or their authorized
representative is registered at BDA under the terms of Chapter II.

Art. 107 When the incident or potential incident is the result of combined use of two or more
individual devices and/or accessories manufactured by different manufacturers, each
manufacturer shall submit to BDA an individual report under Art. 106.

Art. 108 Immediately upon receipt of information for an incident or potential incident, the
manufacturer shall notify his or her authorized representative under Art. 10, par. 2, the
wholesale trader, and the notified body that has performed the assessment on the device
conformity with essential requirements.

Art. 109 (1) The Bulgarian Drug Agency maintains a system for registering, analyzing and
summarizing of incidents or potential incidents with medical devices.
(2) The Bulgarian Drug Agency publishes on its web page the manuals for tracing the safety
of medical devices, issued by the European Commission and the European Medicines
Agency.

Art. 110 (1) The Bulgarian Drug Agency registers in the system under Art. 109, par. 1 the
data from the preliminary manufacturer’s report and evaluates the information provided.
(2) The Bulgarian Drug Agency supervises the manufacturer’s procedures regarding the
investigation of the incident or potential incident and may issue directions and instructions.
(3) During the investigation of the incident or potential incident BDA assists the
manufacturer, if necessary, to contact:
1. the notified body that has performed conformity assessment;
2. regulatory authorities of other affected member states or states from the European
Economic Area;
3. regulatory authorities of member states or states from the European Economic Area for
medical devices in the case of incidents or potential incidents with devices under Art. 3, item
2, 3 and 4;
4. other manufacturers in the cases under Art. 107;
5. users of the device or third persons.

Art. 111 In case the preliminary report under Art. 106 specifies corrective actions, or contains
the conclusion that the incident threatens the safety of patients, medical specialist or third
persons but corrective actions have not been defined yet, BDA sends a report to the regulatory
authorities of member states, states from the European Economic Area, and the European
Commission.


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Art. 112 (1) Within three months after submission of the report under Art. 106, the
manufacturer prepares and presents to BDA a final report in a form approved by the
Executive Director.
(2) The report under par. 1 may contain one of the following conclusions:
1. it is not necessary to take any measures;
2. additional tracing of the device or batch of devices that have been put into service at the
sites under Art. 83, par. 1, item 2 and 3;
3. distribution of information to medical specialists at sites under item 2 and at pharmacies
and drugstores in the form of written recommendation prepared by the manufacturer;
4. corrective actions in the course of future manufacturing;
5. corrective actions on the device put into service at sites under item 2;
6. withdrawal of the device or batch of devices that have been placed on the market and/or put
into service.

Art. 113 (1) In the cases under Art. 112, par. 2, item 2, BDA shall control the manufacturer’s
actions on the territory of the Republic of Bulgaria.
(2) In the cases under Art. 112, par. 2, item 3, BDA shall evaluate the content of the written
recommendation and discuss with the manufacturer the addressees of the recommendation
and its way of distribution.
(3) In the cases under Art. 112, par. 2, item 5, BDA may perform an on-site inspection.
(4) The Executive Director of BDA shall issue an order that the manufacturer block or
withdraw the device or batch of devices with which the incident or potential incident has
happened, in case it is established that the manufacturer has not:
1. performed corrective actions within the term specified by him/her in the report under Art.
112;
2. withdrawn the device or batch of devices from the market within the term specified by
him/her in the report under Art. 112;
(5) The terms and procedures for blocking, withdrawal and/or destruction of devices which do
not comply with the requirements of this Act shall be defined with a regulation by the
Minister of Health.

Art. 114 (1) The Bulgarian Drug Agency shall publish on its web page a list of the devices
included in the ordinance under Art. 113, par. 4.
(2) When the devices under par. 1 are sold at sites under Art. 83, par. 2, BDA informs the
public through BTA and the mass media.
(3) The Executive Director of BDA issues a report for an incident that has occurred or a
potential incident in cases under Art. 112 and sends a copy to the European Commission and
the Regulatory Authorities of the member states.

Art. 115 (1) Any direct notice to BDA regarding an incident or potential incident with
medical device on the territory of the Republic of Bulgaria, handed by an identified person in
writing, shall be documented in the system under Art.109.
(2) Within three days after receiving the notice for the incident or potential incident under
par.1 BDA informs the manufacturer so that he/she undertakes the necessary measures
defined under Art.106 - 108 and Art.112.

Art. 116 BDA can be Coordinating Regulatory Authority:
1. in the case of incident or potential incident which has occurred on the territory of more than
one member state or a state from EEA, and


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2. when the incident or the potential incident is registered for the first time on the territory of
the Republic of Bulgaria, or
3. when the body which has conducted the assessment of the device conformity with the
essential requirements has obtained an authorization under Chapter IV, in case the incident or
the potential incident has occurred with devices from class IIа, IIb or class III, or in-vitro
diagnostic medical devices from list А or list B, or self-testing devices, or
4. when the manufacturer or his/her authorized representative is registered at BDA under the
terms of Chapter II, in case the incident or the potential incident has occurred with devices
from class I or in-vitro diagnostic medical devices which are not from list A and list B and are
not for self-testing.

Art. 117 Personal data of the source of notice shall be stored by BDA according to the
requirements of Personal Data Protection Act.

                                    Chapter Eight
                                EUROPEAN DATABASE

Art. 118 Immediately upon receipt, the Executive Director of BDA presents to the European
database the following information in a standard format:
1. data regarding the registration of the manufacturers or their authorized representatives and
the devices under Chapter II;
2. data obtained from clinical studies of medical devices under the terms of Chapter III;
3. data obtained upon tracing the safety of medical devices placed on the market and/or put
into service on the territory of the Republic of Bulgaria under Chapter VII;
4. data regarding the issue, change, supplement, temporary termination, withdrawal or refusal
of certificates by the notified bodies according to the procedures specified in the regulations
under Art. 18.


§ 2. This Law introduces the requirements of Council Directive 90/385/EEC on the
approximation of the legislation of Member States relating to active implantable medical
devices, Directive 93/42/EEC concerning the medical devices and Directive 98/79/EC of the
European Parliament and of the Council on in vitro diagnostic medical devices (IVDMD).
§ 3. (1) Names and registration numbers of harmonized European standards and the
monographs of the European pharmacopoeia for medical devices are published in the Official
Journal of EU.
(2) Harmonized European Standards are introduced identically through publishing the text of
the standard in Bulgarian or confirming their application as a Bulgarian Standard according to
the State Standardization Act.
(3) Names and registration numbers of the Bulgarian standards introducing the harmonized
European standards are published in the official bulletin of the State Agency for Metrology
and Technical Surveillance and upon publishing it is obligatory that reference to the relevant
regulation under Art. 18 is indicated.
§ 4. (1) The general technical specifications define the requirements for assessment and re-
assessment of service, of placing on the market and/or putting into service of batches,
referent methods and referent materials for IVDMD.
(2) The general technical specifications are published in the Official Journal of the EU.




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