The instruction for use, as well as product labelling, is a source of information about the product itself, its manufacturer, correct and safe use of the product, taking into account the level of training and qualifications of consumers and users.
As a rule, an instruction for use is included in the packaging of each medical device. However, the instruction may be unnecessary for medical devices of class I or class IIa, if such products can be safely used without it.
An instruction for use can also be downloaded from the manufacturer’s website. In this case, the manufacturer must indicate the web address on the packaging of the product, where a user can freely read the manual for the product.
Regulatory requirements on instruction for use of a medical device are set forth in several regulatory acts of Ukraine at the same time, therefore it is necessary to have some knowledge in order to comply with all Ukrainian regulatory requirements regarding manuals for medical devices.
JERELO is certified according to ISO 13485 in the sphere of consulting services on technical regulation. Our specialists have the necessary knowledge and experience in all regulatory issues of distribution of medical devices.
For any additional questions, you may always contact our specialists by phone +38044 360 30 11.