CF “Patients of Ukraine” continues its work on the project “Aligning for Access: Ukraine’s Roadmap to EU-Compliant Medical Devices,” with financial support from the Ukraine2EU Programme. The project aims to support Ukraine in aligning its medical device legislation with EU requirements while ensuring uninterrupted patient access to safe and effective medical devices.
The project team is currently focused on the analytical phase. A methodology for the Extended Regulatory Impact Assessment has already been developed and approved, Ukrainian and EU legislation — including EU Regulations 2017/745 and 2017/746 — has been analysed, along with the experience of EU Member States. Data collection and an assessment of how the transition to the new regulatory framework may affect the medical device market, public authorities, businesses and, most importantly, patients’ access to essential medical devices and equipment are ongoing.
This work will result in a roadmap for aligning Ukrainian legislation with EU requirements and evidence-based recommendations for further regulatory decisions. For patients, this means one simple but crucial thing: European standards should improve the quality and safety of medical devices, but their implementation must not lead to shortages, higher costs or reduced access to modern medical technologies. This is why regulatory changes must be evidence-based and take into account the realities of the Ukrainian market.
This material was prepared with the financial support of the Ukraine2EU Programme. Its contents are the sole responsibility of CF “Patients of Ukraine” and do not necessarily reflect the views of the Ukraine2EU Programme or the European Union.
