The law on medical devices and new technical regulations are interrelated processes

20/ 09/ 2021

The Law of Ukraine On Medical Devices should be adopted by December 15, 2021. This is stated in the Presidential Decree of August 18. This document is meant to comply with European directives. The European Business Association supports this decision, as such an initiative can have a positive impact on the field of medical devices, provided that the Law will: · be qualitatively developed with the active involvement of the public; · meet the needs of the modern market of Ukraine; · consider national intricacies and implement the international regulation practice. In Ukraine, the main documents governing the field of medical devices are three technical regulations developed and adopted in accordance with European requirements. Their adoption in 2013 was a landmark event in the field of medical devices, received support and recognition from the European medical community. This made it possible to restore and develop the market for medical devices in a new way, which became especially relevant at the beginning of the ongoing epidemic. However, the world dictates new rules and motivates to make legislative updates in this field. Despite the widespread use of the directives in the European Union, the EU countries have decided to update them to best meet modern requirements, as well as to introduce better and broader control and monitoring of the process of manufacturing medical devices, their compliance with standards and application on the market. To this end, in 2015 the updating of two directives began, which ended with the adoption of an updated version in 2017 with a sufficient transition period of 4 and 5 years. That is, they entered/will enter into force from May 26, 2021, and 2022 accordingly. Thus, European manufacturers have already started working under the new regulations. Most importantly, the updated regulations repealed previous directives on medical devices. In parallel with the EU, Ukraine is also preparing for the update and the transition followed. Thanks to the Ministry of Health of Ukraine, EBA experts also have an opportunity to be involved in this process. Thus, work on updating the technical regulations is in the active phase, and a package of documents is being prepared for their adoption. It is worth noting that the update of technical regulations is an extremely important step for Ukraine in synchronizing its standards with the EU, as these are the requirements of the ACAA Agreement (Agreement on Conformity Assessment and Acceptance of Industrial Goods). For example, the new regulations introduce a unique coding of each medical device to track its further use and prevent counterfeiting. The development of new medical devices is proceeding at an extremely rapid pace. Accordingly, the legislators of the countries need to take into account this pace and keep up with it. Meanwhile, the EBA understands the importance of these two global projects (technical regulations and the Law of Ukraine On Medical Devices) and the significant workload of MoH experts. So, we consider it necessary to identify vectors of activity, namely – the adoption of technical regulations with a transitional period of 5-10 years for implementation, with the parallel development of the law, even if it will take more time than before the end of this year. We hope that the law will be a paragon of quality legislation for many years to come and become a hallmark for the Ukrainian industry of medical devices in the international professional environment. Therefore, this process should be approached in a strategic and careful way. Be the first to learn about the latest EBA news with our Telegram-channel – EBAUkraine.

The Law of Ukraine “On Medical Devices” should be adopted by December 15, 2021. This is stated in the Presidential Decree of August 18. This document is meant to comply with European directives.

The European Business Association supports this decision, as such an initiative can have a positive impact on the field of medical devices, provided that the Law will:

· be qualitatively developed with the active involvement of the public;
· meet the needs of the modern market of Ukraine;
· consider national intricacies and implement the international regulation practice.

In Ukraine, the main documents governing the field of medical devices are three technical regulations developed and adopted in accordance with European requirements. Their adoption in 2013 was a landmark event in the field of medical devices, received support and recognition from the European medical community. This made it possible to restore and develop the market for medical devices in a new way, which became especially relevant at the beginning of the ongoing epidemic. However, the world dictates new rules and motivates to make legislative updates in this field.

Despite the widespread use of the directives in the European Union, the EU countries have decided to update them to best meet modern requirements, as well as to introduce better and broader control and monitoring of the process of manufacturing medical devices, their compliance with standards and application on the market. To this end, in 2015 the updating of two directives began, which ended with the adoption of an updated version in 2017 with a sufficient transition period of 4 and 5 years. That is, they entered/will enter into force from May 26, 2021, and 2022 accordingly. Thus, European manufacturers have already started working under the new regulations. Most importantly, the updated regulations repealed previous directives on medical devices.

In parallel with the EU, Ukraine is also preparing for the update and the transition followed. Thanks to the Ministry of Health of Ukraine, EBA experts also have an opportunity to be involved in this process. Thus, work on updating the technical regulations is in the active phase, and a package of documents is being prepared for their adoption.

It is worth noting that the update of technical regulations is an extremely important step for Ukraine in synchronizing its standards with the EU, as these are the requirements of the ACAA Agreement (Agreement on Conformity Assessment and Acceptance of Industrial Goods). For example, the new regulations introduce a unique coding of each medical device to track its further use and prevent counterfeiting. The development of new medical devices is proceeding at an extremely rapid pace. Accordingly, the legislators of the countries need to take into account this pace and keep up with it.

Meanwhile, the EBA understands the importance of these two global projects (technical regulations and the Law of Ukraine “On Medical Devices”) and the significant workload of MoH experts. So, we consider it necessary to identify vectors of activity, namely – the adoption of technical regulations with a transitional period of 5-10 years for implementation, with the parallel development of the law, even if it will take more time than before the end of this year. We hope that the law will be a paragon of quality legislation for many years to come and become a hallmark for the Ukrainian industry of medical devices in the international professional environment. Therefore, this process should be approached in a strategic and careful way.

Be the first to learn about the latest EBA news with our Telegram-channel – EBAUkraine.