In practical activities sometimes there is a question of what is the spare part to a medical product. Often such need arises during the purchasing and realization of medical products. The matter is that at sale of medical products providing registration certificates is necessary, and spare parts and details to medical products of registration certificates have no, therefore, their granting is not required. Where to take definition to the concept "spare part"?
Now the law on medical products which draft was discussed on the Internet about 10 years ago is not adopted and hardly the law on medical products will be adopted in the nearest future. Therefore we will consider the available documents where definition of the spare part to a medical product is given.
Perhaps, the most accurate definition is contained by GOST P 58451-2019 "Products medical. Maintenance. Basic provisions" in which the following definition is given: "Spare part: The separate knot, the device or an element intended for replacement of the worn-out, faulty or refused object components for the purpose of maintenance or restoration of its operating state".
Also criteria of differentiation of a medical product, the spare part or belonging to a medical product are established in the decision of Board of the Eurasian economic commission of 24.07.2018 No. 116 "About Criteria of differentiation of the elements of a medical product which are components of a medical product for the purpose of its registration" which became effective from 25.08.2018. The spare part is understood as the part of a medical product intended for the replacement which was in operation of the same part for the purpose of maintenance or restoration of serviceability, or operability of a medical product.
Besides, when determining whether the products are a separate medical product or the spare part it is necessary to be guided by criteria of reference of products to medical products which is given in the recommendation of Board of the Eurasian economic commission of 12.11.2018 No. 25 "About criteria of reference of products to medical products within the Eurasian Economic Union", in which it is specified that "Purpose of a medical product is one of the main criteria of reference of products to medical products. Use of a medical product has to provide its medical purpose. Such medical purpose has to be the only thing or the basic".