Implementation of REACH and іntroduction of new technical regulations on medical devices and In vitro diagnostic devices: Meeting of the EBA Health Сare Committee’s Medical Devices Subcommittee

13/ 08/ 2025

On 6 August, the Medical Devices Subcommittee of the European Business Association’s Health Care Committee held its regular meeting in a hybrid format, dedicated to recent regulatory changes in the circulation of medical devices and in vitro diagnostic medical devices. During the meeting, Olena Sherstiuk, Chair of the Subcommittee, presented an analysis of the provisions of the Technical Regulation on the Safety of Chemical Products (REACH Regulation), focusing on its impact on the circulation of medical devices in Ukraine. The discussion centred on general requirements, the specifics of its effect on the national market, and practical examples. As an instrument for regulating chemical safety in the European Union, REACH, with the adoption of the local Technical Regulation, presents a new challenge for Ukrainian manufacturers and importers of products falling within its scope. Companies must now carefully assess the chemical composition of their products, register chemical substances, obtain permits, and comply with requirements for informing about potential risks to human health and the environment. Member companies received comprehensive answers to practical questions related to implementing REACH provisions in their operations, from defining areas of responsibility to understanding action algorithms in cases where products fall within the scope of the relevant requirements. Participants also discussed the status of introducing new technical regulations on medical devices and in vitro diagnostic medical devices. In particular, they received updated information on draft government resolutions and detailed clarifications on the transitional periods envisaged therein, as well as the opportunity to raise questions of concern to businesses preparing for the new requirements. We sincerely thank all participants for their active engagement! The EBA will continue to facilitate professional dialogue between business and regulatory authorities to ensure the transparent implementation of European requirements in Ukraine.

During the meeting, Olena Sherstiuk, Chair of the Subcommittee, presented an analysis of the provisions of the Technical Regulation on the Safety of Chemical Products (REACH Regulation), focusing on its impact on the circulation of medical devices in Ukraine. The discussion centred on general requirements, the specifics of its effect on the national market, and practical examples.

As an instrument for regulating chemical safety in the European Union, REACH, with the adoption of the local Technical Regulation, presents a new challenge for Ukrainian manufacturers and importers of products falling within its scope. Companies must now carefully assess the chemical composition of their products, register chemical substances, obtain permits, and comply with requirements for informing about potential risks to human health and the environment.

Member companies received comprehensive answers to practical questions related to implementing REACH provisions in their operations, from defining areas of responsibility to understanding action algorithms in cases where products fall within the scope of the relevant requirements.

Participants also discussed the status of introducing new technical regulations on medical devices and in vitro diagnostic medical devices. In particular, they received updated information on draft government resolutions and detailed clarifications on the transitional periods envisaged therein, as well as the opportunity to raise questions of concern to businesses preparing for the new requirements.

We sincerely thank all participants for their active engagement! The EBA will continue to facilitate professional dialogue between business and regulatory authorities to ensure the transparent implementation of European requirements in Ukraine.