Medical devices for in vitro diagnostics intended for human use and accessories to such devices

Draft Resolution of the Cabinet of Ministers of Ukraine "On Approval of Technical Regulation on Medical Devices for In Vitro Diagnostics"; (202 page(s), in Ukrainian)

The draft Resolution provides for the update the provisions of the Technical Regulation on Medical Devices for In Vitro Diagnostics, developed on the basis of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU.

The draft Technical Regulation on Medical Devices for In Vitro Diagnostics sets requirements for such devices and clarifies the responsibilities of manufacturers, authorised representatives, importers and distributors.

It establishes requirements for conformity assessment bodies, strengthens governmental supervision over their activities, modifies the classification rules for certain medical devices for in vitro diagnostic and expands the scope of application. Medical devices for in vitro diagnostics will be classified according to associated risk: from Class A (for low-risk devices) to Class D (for high-risk devices). This classification will replace the two lists currently in effect, which cover only a small portion of devices.

A new provision also regulates the distance selling of medical devices for in vitro diagnostic through information and communication systems (including via the Internet) and introduces detailed rules and reinforced requirements for clinical evaluation, post-market surveillance, post-market clinical follow-up, safety monitoring by manufacturers and market surveillance by the competent authorities.

A Unique Device Identification (UDI) System is being introduced to ensure traceability of medical devices for in vitro diagnostic, enhance monitoring efficiency and reduce the risks of medical errors and counterfeiting. Each medical device for in vitro diagnostic will have a unique UDI code identifying the manufacturer, device type, device number or batch number. This will also contribute to greater transparency in the medical devices market by establishing a medical devices database, including in vitro diagnostic medical devices. The medical devices database will include electronic systems such as an electronic device registration system, a UDI database, an electronic system for the registration of economic operators, an electronic system for designated bodies and certificates, an electronic system for performance evaluation, an electronic system for device vigilance, post-market surveillance and an electronic system for market surveillance.

Before placing high-risk medical devices for in vitro diagnosis of classes C and D on the market, except for investigational devices, manufacturers will be required to provide a brief summary of the main aspects of device safety, performance and evaluation results, which will be publicly available on the manufacturer's website and in Eudamed. They will also be required to implement a comprehensive post-market performance monitoring system as part of their quality management system.

New responsibilities are also established for manufacturers, importers, distributors and authorised representatives to provide the competent authority with information on the full supply chain of medical devices for in vitro diagnostic. If such information cannot be provided, they shall assume full legal responsibility for the medical device for in vitro diagnostic.

For export purposes and at the request of the manufacturer or authorised representative, a free sale certificate shall be issued certifying that the manufacturer or authorised representative, as applicable, has a registered place of business in Ukraine, and that the product in question is marked with a conformity mark in accordance with this Technical Regulation and may be placed on the market.

Once adopted, the Technical Regulation shall enter into force on the date of its publication and will become applicable five years thereafter. Until that time, the current Technical Regulation shall remain in force. To facilitate adaptation to the new requirements, the draft Resolution also provides for transitional periods, similar to those established under Regulation (EU) 2017/746.