In Ukraine, medical devices fall within the scope of three technical regulations, depending on their purpose.
These technical regulations are:
It should be noted that today in the European Union there is a Regulation in force: REGULATION (EU) 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 .
Thus, it can be declared that today the technical regulations of Ukraine regarding medical devices do not comply with the requirements established for medical devices by the legislation of the European Union.
This is fundamentally important when assessing the conformity of medical devices by certification bodies, which have signed agreements with notified EU conformity assessment bodies on mutual recognition of the results of work, because the legislation of Ukraine and the EU in this area are different.
When assessing the conformity of medical devices with the requirements of technical regulations, various procedures can be implemented, prescribed for a particular class of medical devices in the relevant annexes of technical regulations.
Recently, the practice has developed that a number of accredited and authorized bodies for conformity assessment of medical devices practice refusal of customers to assess conformity with technical regulations on medical devices by the procedure, which is regulated by the 4th and 5th appendices to technical regulations ("product lots").
This is contrary to the conditions of their accreditation and authority and such practice may be the basis for demands to terminate the accreditation of such a conformity assessment body and withdraw it from the register of authorized bodies for conformity assessment, as these bodies are accredited and authorized by the requirements of all technical regulations without restrictions.
