As part of the implementation of the task of gaining full membership of Ukraine in the EU, in particular, the short-term improvement of the domestic system of technical regulation, namely the adaptation to EU requirements of Ukrainian legislation, caused the reform of the system of admission to the market of medical devices in Ukraine from July 1, 2015.
Technical regulations for medical devices were first adopted in 2008, but their mandatory application was postponed from year to year. The technical regulations were revised; their latest editions were approved by Cabinet of Ministers of Ukraine resolutions No. 753, No. 754, and No. 755 dated October 2, 2013.
From July 1, 2015, the technical regulations acquired the status of mandatory application for all medical products, with the exception of products registered, according to the legislation in force until July 1, 2015, which are allowed to be put into circulation and used as intended without taking into account the new requirements.
The Technical Regulations do not apply to medical products that have undergone state registration:
• until July 1, 2016 for products whose certificate validity period is unlimited or expires after the specified date;
• before the expiration of the state registration certificate — for medical devices, the validity period of the mentioned certificates, which expire before July 1, 2016.
Such medical devices are allowed to be sold and used before their expiration date without passing conformity assessment procedures and labeling with the national conformity mark.
Thus, within a year from the moment of mandatory application of the technical regulations, both registered medical products with the indication of the symbol of the number of the state registration certificate and products that have passed the assessment of conformity according to the technical regulations and are marked with the national mark will be brought to the market compliance.
It is important to note that the labeling of medical devices cannot contain both of the above-mentioned symbols at the same time. Products can be put into circulation if there is a certificate of state registration or according to the results of conformity assessment works, namely if there is a declaration of conformity. At the same time, the labeling of those medical products that were put into circulation with a valid state registration certificate and are in circulation or operation should not contain the national mark of conformity.
At the same time, it should be noted that according to the adopted changes in the legislation in the field of circulation of medical products, hygienic products cannot be considered as a medical product. This is due to the definition of the term "Medical product" in the Technical Regulations on Medical Products (PCMU No. 753). An example of such products can be:
• feminine hygiene products;
• baby hygiene products;
•baby hygiene productsother products, such as cotton pads (sponges), cotton sticks, etc.
Such products are subject to the requirements of the Laws of Ukraine "On ensuring the sanitary and epidemiological well-being of the population", "On the general safety of non-food products", "On the principles of the state language policy" and other by-laws. For the production, import and introduction into circulation of hygienic products, it is necessary to comply with regulatory and legal requirements.
Classification of medical products
Depending on the field of application, medical products belong to one of three Technical Regulations:
• Technical regulation on medical devices;
• Technical regulation on medical devices for in vitro diagnostics;
• Technical regulation on active medical devices that are implanted.
Conventional medical devices that do not belong to medical devices for in vitro diagnostics and active medical devices that are implanted are, in turn, divided into classes I, IIa, IIb and III.
Products for in vitro diagnostics belong to lists "A", "B", products for self-testing, products intended for evaluation of characteristics, as well as products not included in lists "A", "B", which are not products for self-testing and ratings of characteristics.
Depending on the classification of medical devices, the conformity assessment procedure may differ significantly, including the question of the need to involve the designated body to carry out the mentioned procedure.
For the safest medical devices, it is enough to carry out the self-declaration procedure, checking the compliance of the medical device with the main requirements of the relevant technical regulation, drawing up a declaration of conformity and marking it with the national mark of conformity.
Involvement of the designated body in relation to such products is not provided for.
For other medical devices, it is possible to choose the method of carrying out the conformity assessment procedure, in particular by means of production inspection or laboratory tests.
