of June 9, 2017 No. 102
About medical products
The parliament adopts this organic law.
(1) This law establishes prerequisites for introduction on the market and commissioning of medical products, legal and institutional base for control and supervision of medical products by their provision in the market and use, and also for supervision of sales activity, to distribution of medical products and rendering the related services.
(2) the Purpose of this law is providing optimum conditions for provision in the market of high-quality, effective and safe medical products, for quality assurance of the provided medical services, protection and promotion of health of the population.
(3) This law is applied to medical products, the active implanted medical products, medical products to diagnostics of in vitro. For the purpose of this law of accessory are considered as medical products.
(4) This law is not applied to:
a) to drugs;
b) cosmetic products;
c) human blood, products from blood of the person, to human plasma or blood cells of human origin or products which at the time of their provision in the market include such products, and also to derivative products of blood, plasma or cages;
d) to the transplants, fabrics or cages of human origin and products including fabrics or cages of human origin or received from them;
e) to transplants, fabrics or cages of animal origin, except for the products made with use of impractical fabrics of animal origin or the impractical products received from fabrics of animal origin;
f) to the individual protection equipment falling under action of the Order of the Government about approval of some technical regulations No. 138/2009. In case of decision making that the similar product falls under operation of this law, its basic provided purpose is considered.
For the purpose of this law the basic concepts used in it mean:
accessory – any product which, without being medical product, is specially intended for its application together with medical product, for the purpose of use of the last according to the appointment provided by the producer;
medical product – any tool, the device, the device, material or other product used separately or in combination, including the software, necessary for its proper functioning, intended by the producer for use in relation to human body on purpose:
a) diagnostics, prevention, observation, treatment or decrease in sharpness of course of disease;
b) diagnostics, prevention, current control, treatment, decrease in sharpness of course or compensation of injuries or limited opportunities;
c) researches, replacements or modifications of anatomic form or physiological process;
d) conception regulations and which basic provided purpose is not implemented by impact by pharmacological, immunological or metabolic means in human body or on it, but to functioning of which these means can promote;
active medical product – medical product which functioning depends on source of electrical energy or any other power source, except for the energy generated by human body or gravity;
the active implanted medical product – the active medical product intended for introduction fully or partially by medical or surgical intervention in human body or in anatomic opening and leaving on the place of introduction;
medical product for diagnostics of in vitro – the medical product which is reagent, reaction product, the calibrator, control material, set, the tool, the device, the device or system, used separately or in combination, developed by the producer for application out of human body with research purpose of the tests including taken from human body of donor blood and fabric, only or mainly for the purpose of receipt of any following information:
a) about physiological or pathological condition or congenital anomalies;
b) about degree of safety and compatibility with potential receivers;
c) for monitoring of therapeutic actions;
the medical product made to order - any medical product intended for the specific patient according to the written instruction of the skilled health worker who establishes special product characteristics under own responsibility. Medical products of mass production which shall be adapted to conform to specific requirements of the instruction of the skilled health worker are not considered as the products made to order;
the medical product intended for clinical trials - medical product, held for use appropriately skilled health worker when performing the clinical trials specified in this law, in adequate clinical conditions for the person;
clinical data - the data concerning safety and/or efficiency, received in the course of use of medical product. Clinical data are obtained on basis:
- clinical testing of the corresponding medical product;
- clinical testing or other researches to which specialized literature which object is the similar medical product for which equivalence with the corresponding product can be proved refers;
- the published and/or unpublished reports on other clinical experiments made with this medical product or with similar product for which equivalence with the corresponding product can be proved;
reservoir for collection of tests – the medical product for diagnostics of in vitro, vacuum or not vacuum type intended by the producer especially for storage in it the tests received from human body with I aim performing diagnostics of in vitro.
incident - any defect in work of medical product or violation of its characteristics and/or efficiency which can bring or which led to death or to serious damage to the state of health of the patient or user;
registration – the action which is coming to the end with execution of the document producing the objective evidence of the performed activities or the received results in the field of medical products;
the adjusting servicing – the activities directed to elimination of defects of medical products and to implementation of all works necessary for the problem resolution and recovery of the equipment in the optimum working condition;
preventive maintenance – the activities directed to preserving medical product in the safe and preventing its damage condition;
the program of supervision – set of the measures applied by the user by means of which safety of functioning and quality characteristics of medical product according to the provided appointment to the entire period of its operation are provided and prove to be true and incidents in case of its use come to light;
commissioning – stage at which the medical product is made for the first time available to the user as product, ready to use, according to the provided appointment;
the provided appointment – use of medical product on its purpose, according to the instructions of the producer provided on the label in operating instructions and/or in promotional materials;
the user – medical and sanitary organization, in independence of pattern of ownership and form of business, and also its personnel involved in use of medical products including clinical personnel (doctors and nurses), paramedical personnel (radiologists and kinesitherapists) and personnel of support services.
Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info
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