WTO notification · TBT
UkraineAdopted, according to its latest notice
Official title
Draft Resolution of the Cabinet of Ministers of Ukraine 'On Approval of Technical Regulation on Medical Devices for In Vitro Diagnostics'
Ukraine issued an addendum on 18 June 2026 to the earlier TBT notification G/TBT/N/UKR/326. Addenda often report that a measure was adopted, changed, postponed or withdrawn. The measure was first notified on 17 December 2024. The comment period closed on 6 December 2025.
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Medical devices for in vitro diagnostics intended for human use and accessories to such devices
Latest notice (G/TBT/N/UKR/326/Rev.2/Add.1, 18 June 2026)
The latest notice says the measure was adopted or published.
Draft Resolution of the Cabinet of Ministers of Ukraine 'On Approval of Technical Regulation on Medical Devices for In Vitro Diagnostics'
Ukraine notifies the adoption of Resolution of the Cabinet of Ministers of Ukraine No. 758 'On Approval of the Technical Regulation on Medical Devices for In Vitro Diagnostics' of 10 June 2026. The Resolution was published on 16 June 2026 and will enter into force six months from the date of its publication, i.e. on 16 December 2026, except for paragraphs 3 and 4 thereof, which will enter into force on 31 December 2030. The Technical Regulation approved by this Resolution will take effect on 31 December 2030, except for: subparagraphs 2 to 9 of paragraph 27, which will take effect on 31 December 2031; paragraphs 353 to 362, which will take effect on 1 December 2029; paragraphs 194 and 195, which will take effect on the date Ukraine becomes a Member State of the European Union.
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…
Every notice about this measure published here, newest first. Each one is the notifying member's own text.
AddendumG/TBT/N/UKR/326/Rev.2/Add.1
Draft Resolution of the Cabinet of Ministers of Ukraine 'On Approval of Technical Regulation on Medical Devices for In Vitro Diagnostics'
Ukraine notifies the adoption of Resolution of the Cabinet of Ministers of Ukraine No. 758 'On Approval of the Technical Regulation on Medical Devices for In Vitro Diagnostics' of 10 June 2026. The Resolution was published on 16 June 2026 and will enter into force six months from the date of its publication, i.e. on 16 December 2026, except for paragraphs 3 and 4 thereof, which will enter into force on 31 December 2030. The Technical Regulation approved by this Resolution will take effect on 31 December 2030, except for: subparagraphs 2 to 9 of paragraph 27, which will take effect on 31 December 2031; paragraphs 353 to 362, which will take effect on 1 December 2029; paragraphs 194 and 195, which will take effect on the date Ukraine becomes a Member State of the European Union.
RevisionG/TBT/N/UKR/326/Rev.2
Comment deadline: Closed on 6 December 2025
Draft Resolution of the Cabinet of Ministers of Ukraine 'On Approval of Technical Regulation on Medical Devices for In Vitro Diagnostics'
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…
RevisionG/TBT/N/UKR/326/Rev.1
Comment deadline: Closed on 13 July 2025
Draft Resolution of the Cabinet of Ministers of Ukraine 'On Approval of Technical Regulation on Medical Devices for In Vitro Diagnostics'
The draft Technical Regulation on Medical Devices for In Vitro Diagnostics sets out rules for the placing on the market, making available, or putting into operation of medical devices for in vitro diagnostics intended for human use, as well as accessories for such devices. It also applies to efficacy studies conducted in Ukraine related to medical devices for in vitro diagnostic and their accessories. This draft Technical Regulation has been developed based on 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 aims to remove legal, administrative and technical barriers in the field of medical devices, in particular medical devices for in vitro diagnostics, ensuring the safety and efficiency of medical devices on the Ukrainian market, implementing modern European approaches to monitoring the safety and efficacy of medical devices and preventing the entry of unsafe, ineffective and counterfeit medical devices into Ukraine. The draft Resolution also provides that the placing on the market of medical devices for in vitro diagnostics that comply with the requirements of the Technical Regulation on Medical Products for Diagnostics In Vitro, approved by the Resolution of the Cabinet of Ministers of Ukraine No. 754 of 02 October 2013, is permitted provided a valid certificate of conformity and/or declaration…
Regular notificationG/TBT/N/UKR/326
Comment deadline: Closed on 15 February 2025
Draft Resolution of the Cabinet of Ministers of Ukraine 'On Approval of Technical Regulation on Medical Devices for In Vitro Diagnostics'
The draft Technical Regulation on Medical Devices for In Vitro Diagnostics sets out rules for the placing on the market, making available, or putting into operation of medical devices for in vitro diagnostics intended for human use, as well as accessories for such devices. It also applies to efficacy studies conducted in Ukraine related to medical devices for in vitro diagnostic and their accessories. It has been developed based on 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: 1) details the responsibilities of manufacturers, authorized representatives, importers, distributors (suppliers), defines the role of the authorized representative, and distinguishes their functions and powers from those of importers and distributors; 2) compared to the effective Technical Regulation on Medical Products for Diagnostics In Vitro, approved by the Resolution of the Cabinet of Ministers of Ukraine of 2 October 2013 No.754 sets stricter requirements for designated conformity assessment bodies and increases the level of control and monitoring of their activities by the authorized state bodies. 3) changes the classification rules for some in vitro diagnostic medical devices and has a broader scope of application. Specifically, it introduces a classification of in vitro diagnostic medical devices by classes…
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