Labelling
correct, competent, complete, accurate information on the label of a medical device for the
Ukrainian market ensures the unimpeded launch of products to the market and distribution
thereof
correct, competent, complete, accurate information on the label of a medical device for the
Ukrainian market ensures the unimpeded launch of products to the market and distribution
thereof
The purpose of marking medical devices is to provide information about a medical device and its manufacturer, its safety and efficacity.
As far as it is possible and appropriate, the information necessary for the safe use of the medical device is placed directly on the medical device and/or on the packaging of each unit of the medical device or, if necessary, on the packaging for sale. If individual packaging of each unit is not possible, then the information is placed on a leaflet attached to medical devices.
The issue of marking of medical devices is regulated in Ukraine by several regulatory documents at the same time, namely:
– The Act of Ukraine on Ensuring the Functioning of the Ukrainian Language as a National Language
– The Act of Ukraine on the General Safety of Non-Food Products
– The Act of Ukraine on Protection of Consumer Rights
– Applicable Technical Regulations, in particular the Technical Regulations on Medical Devices, Technical Regulations on Medical Devices for in vitro Diagnostics, Technical Regulations on Active Implantable Medical Devices, as approved by Resolutions of the Cabinet of Ministers No. 753, 754, 755 dated 02/10/2013, Technical Regulations on Restriction of Use of Some Hazardous Substances in Electrical and Electronic Equipment, as approved by Resolution of the Cabinet of Ministers of Ukraine No. 139 dated 03/10/2017 and other applicable Technical Regulations.
We should also note the specialized standards for marking of medical devices (for example, standards EN 15223-1:2018, EN 15986:2015), which become mandatory for the manufacturer declaring compliance with these standards.
These documents establish requirements for the label of a medical device, and more specifically, for the information that should be displayed on the label.
It is also important to understand that marking of a medical device is the information about the medical device which fixes attention of customs authorities in the first place when importing products, and which is assessed by market surveillance authorities after placing products on the market.
Correct, competent, complete, accurate information on the label of a medical device for the Ukrainian market ensures the unimpeded launch of products to the market and distribution thereof.
For any questions on labelling of medical devices, please contact our specialists by phone: +38044 360 30 11.