Health Care

05/ 02/ 2019

The European Business Association (Association) welcomes the publication of the Draft Resolution of the Cabinet of Ministers of Ukraine “On Amendments to the Technical Regulation on Measuring Equipment” on the website of the Ministry of Health of Ukraine dated January 30, 2019. This step, advocated by the Association, is aimed at the elimination of the double conformity assessment procedures for medical devices with a measuring function.

Let us remind you that in September 2016, the Technical Regulation for Measuring Equipment (Technical Regulation No. 94 [1] came into force. Medical devices with measuring function were included to the scope of the regulation. Since then, such devices must undergo mandatory technical regulation twice – according to the Technical Regulations on medical devices [2] and to the Technical Regulation No. 94. Such a practice delays market access of high-quality medical devices as well as tends to increase their final cost.

It is precisely known that such duplicating procedures do not comply with the EU law. The Association has repeatedly requested state authorities for actions and highlighted the necessity to exclude one and all medical devices from the scope of the Technical Regulation No. 94.

We hope that the Draft Resolution will quickly pass the procedure of its approval by the concerned state authorities to be then considered and adopted by the Cabinet of Ministers of Ukraine in the nearest future.

[1] Resolution of the Cabinet of Ministers of Ukraine No. 94 from January 13, 2016 “On Approval of the Technical Regulation on Measuring Equipment”.

[2] Technical Regulations on Medical Devices No. 753 from October 2, 2013; Technical Regulation on In Vitro Diagnostic Medical Devices No. 754 from October 2, 2013, Technical regulations on Active Implantable Medical Devices № 755 from October 2, 2013.

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