On October 20, 2021, the draft Law of Ukraine “On Medical Devices” (hereinafter – the Draft Law) with accompanying documents was posted for public discussion on the official website of the Ministry of Health of Ukraine.
Grounds for drafting the Bill – implementation of the decision of the National Security and Defense Council of Ukraine of July 30, 2021 “On the state of the national health care system and urgent measures to provide Ukrainian citizens with medical care”, enacted by Presidential Decree of August 18, 2021 № 369 / 2021 regarding the submission to the Verkhovna Rada of Ukraine of the draft Law of Ukraine “On Medical Devices” by December 15, 2021, developed in accordance with the norms of European directives.
According to the text of the regulatory impact analysis, the implementation and enforcement of the regulatory act will eliminate the existing legal gap in the absence of sectoral legislation in the field of medical devices and reduce the negative consequences, namely: the presence in the current legislation of Ukraine. and, accordingly, the absence of certain rules of law.
The preamble of the Bill states that it (the Law) regulates legal relations related to the peculiarities of putting into circulation, placing on the market or putting into operation of medical devices, medical devices for in vitro diagnostics, active implantable medical devices, auxiliary means to them.
It is determined that the Law applies to medical devices, medical devices for in vitro diagnostics, active implantable medical devices, aids, products intended for performance evaluation, medical devices intended for clinical trials.
For the purposes of this Law, aids are considered as medical devices.
The Law does not apply to:
1) medicinal products, including medicinal products made from human blood and blood plasma (blood products), which are subject to the Law of Ukraine “On Medicinal Products”;
2) cosmetic products;
3) anatomical materials to which the Law of Ukraine “On the use of transplantation of anatomical materials to humans” applies;
4) food products, including dietary supplements, which are covered by the Law of Ukraine “On Basic Principles and Requirements for Food Safety and Quality”;
5) products of general laboratory purpose, if such products by their characteristics are not intended by the manufacturer specifically for use during in vitro diagnostic testing;
6) products intended only for research work and have appropriate markings.
It is noted that the Bill (in case of its adoption and signing by the President of Ukraine) will enter into force on the day following the day of its publication, and shall enter into force three months after its entry into force.
The bill, among other things, proposes to resolve the existing problem regarding the need for SES conclusions on medical devices by amending the Law of Ukraine “On Ensuring Sanitary and Epidemic Welfare of the Population” with the term “object of state sanitary and epidemiological examination”.
At the same time, the Cabinet of Ministers of Ukraine is instructed to:
– within six months from the day following the day of publication of this Law: bring its regulations in line with this Law; to ensure the review and bringing by the central executive bodies of their normative legal acts in compliance with this Law;
– ensure the entry into force of the relevant regulations from the day following the day of entry into force of this Law.