EU–Ukraine Thematic Meeting on Medical Devices

On 21 November 2025, an EU–UA thematic meeting in the format of a question-and-answer session on medical devices was held within the framework of the EU–UA Twinning Project No. UA 24 UF HE 01 25 “Support the establishment of the state control authority for medicines and medical devices.” The meeting was conducted online and brought together EU experts and representatives of Ukrainian authorities responsible for medical device regulation.

The purpose of the meeting was to exchange views on the implementation of the EU Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR), discuss Ukraine’s draft Technical Regulations, and clarify key institutional and legal aspects of alignment with EU regulatory requirements.

Exchange on the EU Regulatory Framework and National Legislation

During the meeting, the EU expert provided an overview of the legal nature of EU Regulations and their implications for EU Member States and acceding countries. Particular emphasis was placed on the direct applicability of MDR and IVDR upon EU accession, as well as the continuing role of national legislation in areas not fully regulated at EU level.

The discussion highlighted that national legislation should complement EU Regulations by designating competent authorities, defining administrative procedures, and establishing enforcement mechanisms, sanctions, and fees, while avoiding duplication or contradiction of EU law.

Representatives of the Ministry of Health of Ukraine and the State Service of Ukraine on Medicines and Drugs Control presented the current regulatory framework in Ukraine, noting that existing Technical Regulations are still based on former EU Directives. Draft Technical Regulations aligned with MDR and IVDR have already been developed and are planned to enter into force by the end of 2025, including a transitional period.

Institutional Setup, Notified Bodies, and Transitional Issues

A substantial part of the discussion focused on the administrative structure and the distribution of competences in the field of medical devices. The Ukrainian side outlined plans for the establishment of a State Control Agency for medicines and medical devices, which is expected to become operational in 2027 and to consolidate functions currently performed by several institutions.

The meeting also addressed the role of Notified Bodies, including differences between the Ukrainian designation system and EU procedures under MDR and IVDR. EU experts shared Member State experience, noting that some EU countries do not have national Notified Bodies and rely on those designated in other Member States. The need for a dedicated thematic workshop on this issue was acknowledged.

Transitional periods for products certified under previous legislation were also discussed. The EU side noted that such arrangements require approval at EU level and will form part of accession negotiations.

Future Cooperation and Next Steps

Participants also exchanged views on the implementation of the EUDAMED database, acknowledging its complexity and the phased availability of its modules within the EU.

Following the meeting, the parties agreed to:

• the provision by the EU side of written responses to questions raised by the Ukrainian side;
• the continuation of work on aligning the Technical Regulations with the requirements of MDR and IVDR;
• the organisation of a thematic workshop dedicated to Notified Bodies in early 2026.

The meeting concluded with mutual appreciation of the constructive dialogue and confirmation of continued cooperation in support of Ukraine’s regulatory alignment in the field of medical devices within the Twinning project.