Draft Resolution of the Cabinet of Ministers of Ukraine "On Approval of the Technical Regulation on Medical Devices"

Consumer information, labelling (TBT); Protection of human health or safety (TBT); Quality requirements (TBT); Harmonization (TBT)

Medical devices

Link to ePing

11.040 - Medical equipment

Human health

The draft Technical Regulation sets out rules for placing on the market, making available on the market or putting into operation of medical devices intended for human use and accessories for such devices. It also applies to clinical investigations concerning such medical devices and their accessories conducted in Ukraine. The draft  Regulation aims to remove legal, administrative and technical barriers in the field of medical devices, while ensuring the safety and efficacy 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.This draft Regulation has been developed based on Regulation (EU) No 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. 

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