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Requirements for the content of technical and operational documentation

24.03.2017

      The present Requirements define the list of information to be specified in the technical and operational documentation of the medical product manufacturer (producer).

The manufacturer (producer) of the medical product develops technical and (or) operational documentation, according to which he carries out the production, manufacturing, storage, transportation, installation, adjustment, use, operation, including maintenance, as well as repair, utilization or destruction of a medical product.

 Requirements for the content of the manufacturer's (producer's) technical documentation for the medical product:

The manufacturer (producer) technical documentation for the medical product (hereinafter referred to as the technical documentation) provided by the medical product manufacturer (producer) or by the authorized representative of the medical product manufacturer (producer) as part of the Common Technical Document for the medical product shall contain:

1)            the name of a medical product, other information allowing to identify the medical product, for example, the model number, modifications (versions) of the medical product;

2)            the purpose of a medical product and the principles of action;

3)            indications and contraindications for use of a medical product;

4)            information on potential consumers of a medical product;

5)            description of the main functional elements of the medical product, which may be 

provided with diagrams, photographic images, figures, charts and other illustrations;

6)            description of components (units) of a medical product (if any);

7)            description of accessories, medical products or products that are not medical, but intended for use in combination with the stated medical product (if any);

8)            the list and description of the materials of a medical product making direct or indirect contact with the patient's body (human body);

9)            data on marking of a medical product and its package;

10)         the list of risks identified in the risk assessment process and the description of these risks control method in order to reduce them to the tolerable level (if any);

11)         information on the verification and validation of a medical product that was used in order to prove the compliance of the medical product with the applicable requirements, including the results:

a)            tests in testing laboratories (centers);

b)           laboratory and (or) factory tests, including test results under conditions simulating the operational ones;

c)            laboratory animal tests in order to confirm the accuracy of the concept of the finished medical product;

12)         the list of animal test materials and (or) human origin materials with specifyication of the information on their biological compatibility and safety, on the selection of sources (donors), sampling, processing, storage and handling of these materials (if any);

13)         information on the tests carried out, test reports, data analysis;

14)         references to the previous modifications of the medical product or similar modifications of current medical products in case of using the information on similar or previous versions of the medical product in the technical documentation in order to prove the medical product compliance with the safety and efficiency requirements;

15)         information on the main design stages of medical products and information about the production processes, which may be provided with diagrams, photographic images, figures, charts and other illustrations;

16)         information in accordance with the data of the state register of medicinal products for human use about the contained in a medical product:

medicinal product for human use, including the name (international non-proprietary, or grouping, or chemical and commercial name), the name of the manufacturer of the medicinal product for human use, the date and number of the marketing authorization of the medicinal product for human use;

pharmaceutical substance, including the name (international non-

proprietary, or grouping, or chemical and commercial name) the name of the manufacturer of the pharmaceutical substance, the date and number of the registry entry of the State Register of Medicines for human use;

17)         description of the sterilization method, information on validation methods concerning sterilization process (including bioburden tests, tests for pyrogenic agents availability, tests for residual quantity of sterilizing agent) and information on validation of the packaging process (if the medical product is delivered sterile);

18)         information on the process of design, engineering and validating of the software used in the finished medical product (upon the existence of software in the medical product that ensures its proper operation and (or) intended application);

19)         requirements for maintenance and repair of medical products;

20)         the procedure and circumstances for disposal or destruction of a medical product.

 

    Technical documentation of the medical product for in vitro diagnostic, in addition to the information specified above, shall contain:

1)            description of purpose of the medical product, including:

a)            description of the target analyte, information on its scientific validation, specifying of the qualitative, semiquantitative or quantitative analyte type;

b)           functional purpose (for example, screening, monitoring, diagnostics or auxiliary in diagnostics);

c)            specific pathology, condition or risk factor for the detection, definition or differentiation of which a medical product for in vitro diagnostics is intended;

d)           the analytical sample type;

e)           population, demographic aspects of the medical product use;

2)            specification of the professional level of potential users (for example, a pathologist, a medical laboratory technician (medical technologist), another specialist);

3)            description of the principle of the analytical method or the medical product operating principle, for analytical equipment - the corresponding technical specifications;

4)            description of transportation conditions;

5)            information on analytical sensitivity (detection threshold), analytical specificity, diagnostic sensitivity and diagnostic specificity;

6)            description of measuring procedures, metrological traceability of values of calibrators and control materials;

7)            data on the medical product stability, confirming the stated expiration date, usage stability and transportation stability.