Medical devices

Draft Resolution of the Cabinet of Ministers of Ukraine "On Approval of the Technical Regulation on Medical Devices"; (232 page(s), in Ukrainian)

the draft Resolution provides for the update of the provisions of the Technical Regulation on Medical Devices, developed on the basis of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.

The draft Technical Regulation on Medical Devices sets requirements for medical 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 and expands the scope of application.

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

A Unique Device Identification (UDI) System is being introduced to ensure traceability of medical devices, enhance monitoring efficiency and reduce the risks of medical errors and counterfeiting. Each medical device will have a unique UDI code identifying the manufacturer, device type, device number or batch number. The UDI system will be linked to a medical device database that will integrate electronic systems for device registration, registration of economic operators, the UDI database, designated bodies and certificates, clinical investigations, post-market surveillance and market surveillance.

Before placing high-risk medical devices on the market, 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. If such information cannot be provided, they shall assume full legal responsibility for the medical device.

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 provides for transitional periods.