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Article 2
Terms used in this Law, if not specified otherwise by this Law, shall have the following meaning:
1) Medical device (general) means any instrument, apparatus, appliance, software, implant, reagent, material and other product used alone or in combination, including software provided by the manufacturer for diagnostic or therapeutic purposes and which is software support necessary for its proper use in people intended by the manufacturer, and is used for:
(1) diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
(2) diagnosis, monitoring, treatment, alleviation or compensation of injury or disability,
(3) investigation, replacement or modification of the anatomy or physiological or pathological process and state,
(4) providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,
(5) control or support of conception,
(6) products intended for cleaning, disinfection or sterilization of medical devices.
The medical device referred to in paragraph 1 of this item does not fulfil its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but may be assisted in its function by such means;
2) Accessory for a medical device (accessory) is a product that is not a medical device, and which the manufacturer specifically intended to use in combination with a medical device in order to enable the medical device to be used in accordance with its intended use by the manufacturer.
An invasive sampling device or one which is directly applied to the human body for the sampling is not considered in vitro diagnostic medical device, but is considered a general medical device;
3) In vitro diagnostic medical device is any medical device that is a reagent, reagent product, calibrator, control material, set of reagents (kit), instrument, apparatus, equipment, software or system used individually or in combination, intended by the manufacturer for use in the in vitro conditions for the examination of samples, including donations of blood and tissues of human origin, only or mainly to obtain information relating to:
(1) physiological or pathological process or state,
(2) congenital physical or mental anomalies,
(3) predisposition to a health status or illness,
(4) determining security and compatibility with a potential recipient,
(5) predicting responses or reactions to treatment,
(6) defining or monitoring therapeutic measures.
Sample receptacles are considered to be in vitro diagnostic medical devices. Sample receptacles are vacuum- or non-vacuum-type medical devices that the manufacturer explicitly intended for the primary keeping and storing of samples retrieved from the human body for the purpose of in vitro diagnostic testing.
Products for general laboratory use shall not be considered as in vitro diagnostic medical devices unless these products, due to their characteristics, are specifically intended for use in the in vitro diagnostic tests by the manufacturer;
4) Active medical device is any medical device whose effect depends on the source of energy or any source of energy that is not generated directly from the human body or gravity;
5) Implantable medical device is any medical device intended to be completely or partially surgically or physically incorporated into the human body or permanently incorporated into the body orifice and intended to remain in the body after a medical procedure;
6) Active implantable medical device is any active medical device intended to be completely or partially surgically or physically incorporated into the human body or permanently incorporated into the body orifice and intended to remain in the body after a medical procedure;
7) Custom-made device is any medical device that is specifically manufactured at the request of an appropriate healthcare professional who personally specifies the design characteristics of that medical device and is intended for a particular patient.
Custom-made device may be prescribed on a prescription or an order of a person authorised to do so in accordance with the law, or having appropriate professional qualifications.
Mass-produced medical device that needs to be adapted to the specific requirements of a healthcare professional or other professional user is not considered as a medical device manufactured according to the order;
8) Medical device intended for clinical investigation is any medical device intended for use by the appropriate healthcare professional in carrying out clinical trials in a healthcare institution.
Another person shall be considered equivalent to the appropriate healthcare professional in the conduct of a clinical trial if authorised in accordance with the law, or who has appropriate professional qualifications for carrying out a clinical trial;
9) Single-use medical device is a medical device that is intended to be used only once for a single patient during a single procedure. A single-use medical device may be used repeatedly on the same patient or on the same patient over an extended period of time for a single procedure. A critical single-use medical device is a disposable medical device intended for use in surgical invasive procedures;
10) Medical device for self-testing means any in vitro diagnostic medical device intended to be used by non-professionals in the home environment;
11) Performance assessment tool is any in vitro diagnostic medical device which the manufacturer has intended to be the subject of one or more tests for assessing performance in medical analysis laboratories or in any other appropriate environment outside its own premises;
12) Calibrator and control material shall refer to every substance, material or product intended for the determination of measurement relationships or to check the characteristics of the medical device performance in relation to its purpose;
13) Spare part of a medical device is a product that is an integral part of a medical device and is supplied and delivered exclusively for the needs of replacing the existing components of a medical device that is in compliance with the basic requirements. The spare part of a medical device is not considered a medical device;
14) Category of medical devices is a set of medical devices that have a common area of intended use or common technology;
15) Generic device group is a set of medical devices that have the same or similar use or common technology that allows them to be classified in a general manner without reflecting specific characteristics;
16) Categorization of a medical device is a procedure for determining the category of medical device;
17) Classification of a medical device is a procedure for determining the class of the risk of a medical device;
18) Medical device whose manufacturing used animal tissues or products of animal origin is a medical device which must meet certain requirements regarding the risk of transmission of spongiform encephalopathy (TSE) to a patient or other person under normal conditions of use;
19) Natural person is an entrepreneur, that is, a business-capable natural person who performs activity in order to generate income and which is registered as such, in accordance with the law regulating companies and the law regulating registration;
20) Manufacturer of a medical device (hereinafter: the manufacturer) is a legal or natural person responsible for its design, manufacture, packaging and labelling before placing it on the market under its own name, whether or not these activities have been performed independently or on their behalf by another person;
21) Authorised representative of a foreign medical device manufacturer (hereinafter: authorised representative of a manufacturer) is a legal or natural person with a head office in the Republic of Serbia who is solely authorised by the foreign manufacturer in writing to act on their behalf and to conduct the procedures prescribed by this Law and who is responsible for the safety and performance of a particular medical device in the same way as the manufacturer of that medical device;
22) Intended purpose is the use for which the medical device is intended in accordance with the information given by the manufacturer when labelling, in the instructions for use, or in the promotional material;
23) Performance of the medical device is the ability of the medical device to achieve the intended purpose of the manufacturer;
24) Compatibility of a medical device is the ability of a medical device, including the software, when used together with one or more other devices, in accordance with its purpose, to:
(1) operate without losing or compromising the ability to operate as intended, or
(2) integrate, i.e. operate without the need for modification or adaption of any part of the combined device, or
(3) be used together without conflict, i.e. interference or adverse reaction;
25) Placing on the market is the first placement of a medical device with or without compensation in order to distribute or use on the market of the Republic of Serbia, regardless of whether it is new or completely renewed, except for a medical device intended for clinical trial;
26) Putting into service is the phase in which the medical device is available to the end user, ready for use on the market of the Republic of Serbia for the first time and for its intended purpose;
27) Free sale certificate is a document proving that a medical device can be marketed in the country of the manufacturer or on the market of a Member State of the European Economic Area (hereinafter: the EEA Member State);
28) Clinical data are all data on the safety, i.e. the performances of a medical device arising from the use of a medical device. Clinical data come from:
(1) clinical trial i.e. clinical investigations of that medical device, or
(2) scientific literature on clinical trial i.e. clinical investigations or another investigation of a similar medical device for which equivalence with that medical device can be proved, or
(3) published or unpublished reports on other clinical experiences of that medical device or other similar device whose equivalence with that medical device can be proved;
29) Conformity assessment is any activity that determines whether the medical device, that is, the process of manufacturing a medical device, complies with the prescribed technical requirements, or systematic examination of the collected clinical evidence and procedures initiated by the manufacturer in accordance with the essential requirements (hereinafter: essential requirements), in order to establish that the medical device is safe and functioning in accordance with the intended purpose;
30) Conformity assessment body is a company, institution or other legal entity that conducts conformity assessment, or performs technical assessment tasks, including calibration, testing, certification and control. The conformity assessment body is a appointed body or an authorised body or a notified body;
31) Appointed body is the conformity assessment body, appointed by the Minister in charge of health (hereinafter: the Minister) to conduct conformity assessment for the needs of the manufacturer in accordance with this Law and the regulations adopted for its implementation;
32) Authorised body is the conformity assessment body, that is, the testing laboratory, the control body and the certification body, to whom the Minister has given the authority to carry out technical assessment tasks for the needs of the state administration body conducting the conformity assessment in accordance with this Law and the regulations adopted for its implementation;
33) Notified body is the conformity assessment body which is the competent authority of a particular EEA Member State or the state with which the European Commission has concluded a contract on the mutual recognition of conformity assessment procedures, reported to the European Commission for carrying out procedures for assessing the conformity of a medical device with the requirements of the European Union directives, which has its own identification number. A list of approved notified bodies for medical devices is located within the "NANDO" database of the European Commission;
34) Document of Conformity of the medical device is a declaration of conformity, a clinical trial report, a certificate, a control certificate or other document confirming the conformity of the medical device with the essential requirements (hereinafter: the Document of Conformity);
35) Declaration of Conformity is a document by which the manufacturer confirms that the medical device complies with the essential requirements (hereinafter: the Declaration of Conformity);
36) Certificate of Conformity of a medical device is an EC Certificate issued by a appointed body or certificate issued by a notified body certifying that the medical device or group of medical devices of a particular manufacturer complies with the essential requirements (hereinafter: Certificate of Conformity);
37) Technical assessment of a medical device is the testing, or control of a medical device carried out by an authorised conformity assessment body for the needs of the ministry responsible for health (hereinafter: the Ministry) in accordance with this Law and the regulations adopted for its implementation (hereinafter: technical assessment);
38) Marking of conformity of a medical device is a mark which the manufacturer places on a medical device and confirming that the medical device complies with the essential basic requirements. The marking of conformity may be the foreign marking of conformity (CE marking) or the Serbian marking of conformity of the medical device;
39) Serbian marking of conformity of a medical device is a mark certifying that the medical device placed on the market or in use is in compliance with the essential requirements in accordance with this Law and the regulations adopted for its implementation (hereinafter: Serbian conformity mark);
40) EUDAMED is a European database for medical devices that centralises registration data of manufacturers, or authorised representatives of manufacturers and medical devices placed on the market of the European Union, data on issued, amended, supplemented, as well as certificates that have ceased to be valid, which are withdrawn or rejected, data obtained in accordance with the procedure for the vigilance of medical devices and data on clinical trials;
41) CAMD is an association of competent authorities of the EU Member States for medical devices;
42) Distributor is a legal or natural person with headquarters or permanent residence in the Republic of Serbia, who is included in the supply chain and who supplies a medical device in the course of performing their activity, and is not a manufacturer, authorised representative of the manufacturer, wholesaler, importer;
43) Supplier is a manufacturer, an authorised representative of a manufacturer, wholesaler, importer or distributor;
44) Medical device vigilance is a set of activities that assure the collection, assessment, understanding and response to knowledge of the risks arising from the use or application of a medical device, in particular with regard to reporting incidents in order to improve and protect the health and safety of patients, users and other persons and, if necessary, provide information that reduces the likelihood of the incident being repeated or alleviating the consequences of the incident (hereinafter: vigilance);
45) Post-market surveillance monitoring are all activities carried out by the manufacturer or authorised representative of the manufacturer, establishing and maintaining a systematic procedure for proactively collecting and assessing the experience regarding a medical device that has been placed on the market, or in use, in order to identify any need to apply, without delay, all necessary corrective or preventive measures;
46) Market surveillance are activities carried out and measures undertaken by the Ministry and the Medicines and Medical Devices Agency of Serbia (hereinafter: the Agency) in order to check and ensure that the medical devices comply with the essential basic requirements, as well as do not endanger health, safety or any other aspect of the protection of the general interest;
47) Examination of the medical device is the activity of regular or extraordinary examination of the compliance of a medical device with the essential basic requirements for the safety and performance of the medical device during the lifetime of use;
48) Improper use is the act or omission by a person who handles a medical device or by the user, the consequence of which is the behaviour of a medical device that is beyond any risk control by the manufacturer;
49) Corrective action is the activity undertaken by the manufacturer, or the authorised representative of the manufacturer in the event of a potential or established non-conformity of a medical device or other unwanted situation. There may be more non-conformities. Corrective action is taken to prevent repetition, while preventive ones are taken to prevent such an event (Corrective and Preventive Action - CAPA);
50) Field Safety Corrective Action (FSCA) is a measure taken by the manufacturer or an authorised representative of the manufacturer to reduce the risk of death or serious deterioration in the health condition associated with the use of the medical device placed on the market. Such measures, regardless of whether they are related to direct or indirect damage, are reported and recorded through the Field Safety Notice;
51) Field Safety Notice (FSN) is a notice for customers, i.e. users sent from by the manufacturer, or an authorised representative of the manufacturer in relation to the Field Safety Corrective Action;
52) Damage is a physical injury or damage to the health of people, animals or damage to property or the environment;
53) Without delay is the method of urgent action, that is, the treatment whose postponement cannot be justified;
54) Vigilance Coordinator is a healthcare professional employed in a healthcare institution who carries out tasks related to organising and improving the implementation of good practice in collecting and reporting suspicions of incidents and communication about the risks of using medical devices in a healthcare institution and who is the contact person of a healthcare institution for the Agency for the vigilance and which directly cooperates with the Agency. The vigilance coordinator is appointed by a healthcare institution and reports to the Agency with contact information;
55) Incident is any malfunction or deterioration of the characteristics or performance of a medical device, as well as the inadequacy in the labelling or in the instruction for use which, directly or indirectly, led or could have led to the death of a patient, user or other person or serious deterioration their health;
56) Periodic Safety Report is a method of reporting agreed between the Agency and the manufacturer or the authorised representative of the manufacturer on the reporting of similar incidents of the same medical device or type of medical device in a unified manner when the cause is known or Field Safety Corrective Action is implemented;
57) Serious public health threat is any event that can lead to immediate danger of death, serious deterioration of health or serious illness requiring rapid corrective actions, and which includes:
(1) events that are significant and unexpected in nature, so that they become alarming as a potential threat to public health, such as, for example, Human Immunodeficiency Virus (HIV) or Creutzfeldt-Jakob Disease (CJD). This threat to public health may be identified by the Ministry, the Agency or the manufacturer, or the authorised representative of the manufacturer,
(2) possibility of multiple deaths at short intervals;
58) Beneficiary is a healthcare institution, a healthcare professional, a healthcare associate or a patient, i.e. a person using a medical device;
59) Person responsible for the vigilance and monitoring of the medical device on the market is a full-time employee at the manufacturer or an authorised representative of the manufacturer who performs vigilance tasks and has completed medical, dental, pharmaceutical, technological, electro-technical, mechanical, chemical or other appropriate faculty depending on the type of medical device, as well as additional education in the field of vigilance (hereinafter: person responsible for vigilance);
60) Person responsible for the documentation is a full-time employee at the manufacturer or an authorised representative of the manufacturer for affairs in the procedure of registration, amendment, addition, renewal or removal of the registration of a medical device and who has completed medical, dental, pharmaceutical, technological, electro-technical, mechanical, chemical or law faculty;
61) Clinical trial of a medical device is any systemic investigation, examination or study conducted on one or more subjects that is carried out to assess the safety or performance of the medical device (hereinafter: clinical trial);
62) Adverse event in a clinical trial is any unpleasant medical occurrence, accidental illness or injury or an unfavourable clinical symptom (including an unfavourable laboratory finding) in a patient, user or other person, whether or not related to the medical device that is clinically studied. This definition includes events related to a medical device that is clinically studied or a medical device to compare with, as well as events related to the procedures involved. For users or other persons, this definition is limited to events relating to a medical device that is clinically studied;
63) Serious adverse event in a clinical trial is an unwanted event that led to or may lead to death or serious deterioration of the patient's health, resulting in life-threatening illness or injury or permanent damage to the body's structure or function, hospitalization of the patient, or the extension of existing hospital treatment, medical or surgical interventions to prevent illness or injury that is life-threatening or permanent damage to the structure or function, and which may lead to fetal distress, fetal death or congenital anomalies, or effect. Planned hospitalization for the pre-existing condition or procedure required by the Clinical Investigation Plan, without serious harm to health, is not considered a serious adverse event;
64) Adverse effect in a clinical trial is an adverse event in relation to the use of a medical device that is clinically studied. This definition includes adverse effects arising from insufficient or inadequate instructions for use, development, implantation, installation or operation or any malfunctioning of the medical device being clinically studied. This definition includes any event resulting from an error in use or from the deliberate misuse of a medical device that is clinically studied;
65) Ethics Committee of Serbia is an independent expert body that takes care of the provision and implementation of healthcare at the level of the Republic of Serbia, on the principles of professional ethics, composed of prominent experts with significant results in work, as well as contributions in the field of healthcare, professional ethics of the healthcare workers and humanistic sciences in accordance with the law regulating healthcare, whose responsibility is to protect the rights, safety and well-being of subjects involved in a clinical trial, as well as to provide public protection of their rights;
66) Sponsor of the clinical trial is a legal or natural person, i.e. the person responsible for initiating, or obtaining approval for conducting a clinical trial, the implementation and financing of a clinical trial (hereinafter: the sponsor);
67) Lead investigator is a qualified person responsible for the conduct of a clinical trial at the clinical trial site. If a clinical trial is conducted by a team of individuals at the site of a clinical trial, the principal investigator is responsible for team management;
68) Investigator is an individual member of the team at the site of a clinical trial determined by and under the supervision of a lead investigator who performs key procedures in a clinical trial or makes important decisions in relation to a clinical trial (a "sub-investigator" or a "co-investigator");
69) Informed consent of the subjects is a written statement, with the date and signature of the subject, about participation in a particular clinical trial, provided by a person capable of consenting or consent by a legal representative of a person unable to give consent, in accordance with the law, which was given voluntarily after full information about the nature, significance, consequences and health risks (hereinafter: informed consent);
70) Clinical Investigation Plan (CIP) is a document that sets out the basic principles, objectives, design, proposed analyzes, methodology, supervision, implementation and record of the clinical trial (hereinafter: the Protocol);
71) Clinical evaluation is the assessment and analysis of clinical data relating to a medical device in order to check the clinical safety and performance of the medical device;
72) Clinical Evaluation Report refers to the clinical evaluation documentation;
73) Clinical performance is the method of operation of a medical device or the patient's response to a medical device with respect to the purpose of that medical device when correctly applied to the appropriate patient;
74) Clinical safety is the absence of an unacceptable risk from a medical device when used in accordance with the manufacturer's instructions;
75) Device deficiency is any inadequacy of a medical device in relation to identity, quality, durability, reliability, safety or performance. Defects of a medical device include failures, malfunctions and inadequate labelling;
76) Multicentre clinical trial is a clinical trial conducted under a single Protocol at several clinical trial sites and which is carried out by more investigators, regardless of whether the clinical trials are in the same country or in different countries;
77) Post-marketing clinical trial is a clinical trial after completing the conformity assessment, or after labelling with the sign of compliance. Post-marketing clinical trial can be interventional and non-interventional;
78) Post Market Clinical Follow Up Plan (PMCF) are documented, proactive, organised methods and procedures established by the manufacturer for the collection of clinical data based on the use of a medical device labelled with a conformity mark in accordance with the technical documentation or based on the group of medical devices belonging to the same subcategory or general medical devices. The aim is to confirm the clinical safety and performance, as well as the acceptability of the identified risks during the expected lifecycle of the medical device and to detect the risks that may arise from fact-based evidence;
79) Manufacturing process is any process applied in the manufacturing of medical devices, from the procurement and acceptance of starting materials, manufacture, packaging into the inner packaging to labelling and the process of packaging in the outer packaging;
80) Fully refurbishing is the complete rebuilding of a medical device already placed on the market or into service or renewal of a medical device that has been used in order to comply with the essential requirements, with the determination of a new lifecycle of the renewed medical device;
81) Improvement is a process that is performed on a medical device that has been used to enable its safe reuse, including cleaning, disinfection, sterilization and similar procedures, as well as testing and restoring the technical and functional safety of the medical device;
82) Person responsible for the manufacture is a full-time employee with a manufacturer who is responsible for the preparation and implementation of the medical device manufacturing process;
83) Person responsible for quality is a full-time employee with a manufacturer who is responsible for the technical assessment of each batch of medical devices, or who is responsible for the quality of the medical device during the manufacturing process of the medical device, including the systematic documentation of all the starting materials and components, packaging material, intermediate products, manufacturing processes, as well as testing of the finished medical device;
84) Quality assurance is a follow-up process in which quality is introduced at all stages of manufacturing, including a system of documented monitoring of all starting materials and components and a single manufacturing process, or a technical assessment, which includes all controls in relation to the quality of the medical device;
85) Benefit-risk determination is the assessment of the positive effects of a medical device in relation to risks;
86) Batch is a defined quantity of starting materials (starting substances or packaging materials) or products made during one manufacturing process, i.e. manufacture or in a series of manufacturing processes, which should therefore be homogeneous. Batch included the total amount of a medical device that has been manufactured, i.e. made from the same initial quantity of starting materials during one manufacturing process, or the manufacture and one sterilization process, and in the case of continuous manufacture or manufacture, the total amount of a medical device that is produced or made in a certain period;
87) Good Clinical Practice Guidelines are a quality assurance standard for planning and conducting clinical trials to obtain valid clinical conclusions with the appropriate protection of participants in clinical trials;
88) Good Manufacturing Practice Guidelines are the quality assurance guidelines for the organisation, implementation and monitoring of the distribution of medical devices from the manufacturer to the end user;
89) Critical non-compliance of the medical device marketing with the Good Manufacturing Practice Guidelines is the non-compliance which led or may lead to the marketing of a medical device that could endanger the life or health of the public, i.e. public health;
90) Specialized medical device store is a sales facility where retail sale of medical devices is carried out;
91) Inner package of a medical device is a package with which the medical device is in direct contact;
92) Outer package of a medical device is a package in which the inner packaging of the medical device is located;
93) Label is written, printed or graphical information on a medical device, on the packaging of each component of a medical device or on a package of the system or kit and contains information about the authorised representative of the manufacturer and the number of the decision on the registration of a medical device. A sticker with information on the number of decisions on the registration of a medical device in the Republic of Serbia can also be found on the instruction manual;
94) Falsified device is any medical device which is falsely presented in terms of identity, or origin, i.e. CE marking or documentation in connection with CE marking procedures. This definition does not apply to a medical device with inadvertent defects in quality (medical device quality defect) and does not undermine intellectual property rights;
95) Transit is the transport of a medical device through the territory of the Republic of Serbia, without changing the ownership of the consignment and without changing the destination and the user;
96) Unregistered entity is a supervised entity that performs an activity but is not registered in the appropriate register managed by the Business Registers Agency or another authority or organisation responsible for registering the founding of a legal entity and another entity (hereinafter: the Basic Registry), when entry in this register is prescribed as a condition for performing activities;
97) Registration of a medical device is an administrative procedure for the entry of a medical device for which the assessment of conformity has been performed in the register of medical devices managed by the Agency;
98) Unique Device Identification (UDI) is a unique numerical or alphanumeric code referring to a medical device, in two following parts:
(1) medical device identifier;
(2) manufacture identifier.
Unique Device Identification provides access to useful and relevant information regarding the medical device and makes the traceability of the medical device more effective, facilitates the withdrawal of the medical device from the Marketing, stops counterfeiting and improves patient safety. Unique Device Identification is not a substitute for or supplement to prescribed requirements for the labelling of a medical device.
