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Draft Law on Medical Devices is Another Step Toward Bringing Ukrainian Legislation in Line with EU Law

18 November 2023
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The Ministry of Health, together with the Parliamentary Committee on Public Health, Medical Assistance and Health Insurance, has brought the draft law No. 7585 “On Medical Devices and In Vitro Medical Devices” into compliance. It is about harmonizing the draft law with Regulations 2017/745 on medical devices and 2017/746 on medical devices for in vitro diagnostics of the European Parliament and of the Council.

“One of Ukraine’s obligations to the EU under the Association Agreement is to adapt our healthcare legislation to the provisions of EU law. Together with the Verkhovna Rada Committee and business associations, we have done a titanic amount of work, and we have a finalized draft law that is adapted to the requirements of the European Union. This is another small but important step towards approximation of the legislation to the EU acquis and European integration of our country,” said Maryna Slobodnichenko, Deputy Minister of Health of Ukraine for European Integration.

The Law on Medical Devices is not regulatory. The detailed regulation of this area will remain at the level of regulations, and the law itself brings all the necessary terminology in line with European legislation.

In its analytical report of 8 November 2023, the European Commission emphasized that Ukrainian legislation is partially aligned with the EU acquis on medical devices and in vitro medical devices. That is why it is essential to continue to work on the approximation of legislation.

The finalized draft law contains several essential provisions. A framework for clinical trials of medical devices has been developed, including who can act as a sponsor, or researcher, who authorizes clinical trials, and how to report any shortcomings in the process. These are general rules that have been agreed with market operators. It is expected that the clinical trials procedure itself will be approved at the level of the central executive authority.

The draft law introduces the concept of a “counterfeit product” that is in line with the Council of Europe Convention on the Counterfeiting of Medical Products (the Medicrime Convention). The document stipulates that the government should introduce a draft law amending the Criminal Code to regulate the fight against counterfeit products.

The draft law stipulates that it shall enter into force on the day following the day of its publication, and shall be put into effect one year after it enters into force. To effectively implement and apply the provisions of the draft law, the Ministry of Health of Ukraine should develop technical regulations that will comply with EU regulations in this area.

“The Law on Medical Devices should come into force one year after it enters into force. During this time, the relevant technical regulations should be developed and approved. Thus, both the law and the technical regulations will come into force simultaneously,” explained Maryna Slobodnichenko.

At the same time, Article 7 “Electronic Database of Medical Devices” of the draft law comes into force five years after it enters into force. This means that Ukraine will have five years to implement all electronic systems.