There was no unified register of medical devices in Ukraine, which complicated the control and circulation of these products. However, the key idea was to create a single information space for exchanging data on medical devices throughout their entire life cycle.
Introducing a unified electronic register of persons responsible for placing medical devices, active implantable medical devices, and medical devices for in vitro diagnostics on the market made it possible to implement the functionality of the State Register of Medical Devices. Not only did it align with European legislation, but also facilitated the implementation of the relevant system in Ukraine. Particular attention was paid to data interoperability and standardization of exchange processes.Thanks to our work, the transition to the unified Register also simplified and accelerated connections to various software systems used in the medical industry. This has made data exchange more efficient and ensured the safety and quality of medical devices in the Ukrainian market.
1. Proactively involving experts.
2. Gathering requirements and turning them into a technical task for developers.
3. Designing the system from scratch with a new data model.
4. Creating a design system.
5. Ensuring oversight of the development and implementation of the best data security standards.
1. Implement preparatory measures to align the legislative framework with European legislation.
2. Integrate data into other software products, particularly in order to implement the electronic stock management system for medicinal products and medical devices, "eStock," as there are no uniform requirements for the volume and quality of information to be provided.
3. Simplify the entry for new manufacturers and their authorized representatives into the medical device market by creating an electronic document management system. This will save time and money in fulfilling the legislation's requirements for the introduction of modern and required medical devices, active implantable medical devices, and medical devices for in vitro diagnostics.
1. Significant simplification of the entry process for new manufacturers of medical devices into the Ukrainian market through the electronic document management system, unified interfaces, and reference books.
2. Reducing errors in the information section pertaining to the medical devices through the unification of information.
3. Streamlining the process of accounting and administering information on persons and medical devices that have passed the conformity assessment in Ukraine.
4. Reducing the cost of medical devices by eliminating paper-based documents and reducing administrative costs (materials, postage, etc.).
5. Control over the accuracy in the Register.
6. Appointment of new Register users.
7. Creation of APIs for external services.
8. Generating and downloading reports.
