The Medical Device Regulation (MDR) is a regulation for medical devices within the European Union, adopted in 2017 following a series of scandals involving breast implants from PIP Implants and hip implants from DePuy, a subsidiary of Johnson & Johnson. These cases highlighted the need for stricter regulations on medical devices.
Initially, the regulation was scheduled to take effect in May 2020. However, due to the spread of SARS-CoV-2 and the insufficient number of notified bodies, the implementation was postponed by one year to May 2021. By May 2021, the MDR came into effect but included transitional provisions to give manufacturers and market operators additional time to comply. In April 2023, the European Parliament decided to extend the transitional periods of MDR 2017/745 in the EU until 2028, though several requirements are already in force.
This creates challenges for implementing MDR in Ukraine, as adapting the numerous requirements to Ukrainian realities is necessary. Discussions about implementing MDR in Ukraine began in 2019 when the Ministry of Health’s 2020 action plan included preparing Ukrainian technical regulations to meet MDR requirements. However, COVID-19 and the subsequent full-scale war led to delays in implementing MDR requirements in Ukraine.
A primary challenge is the absence of a unified database for medical devices in Ukraine similar to the European EUDAMED database. The European Union encourages the Ukrainian government to harmonize its medical device regulation with European standards but has not included Ukraine in the unified database. This means Ukrainian competent authorities must create a separate database or develop the existing electronic database by the State Service of Ukraine on Medicines and Drug Control (DLS), which currently only covers low-risk medical devices.
Another challenge for medical device manufacturers is the MDR 2017/745, which introduces additional requirements for traceability, including the implementation of a unique device identifier (UDI) for each device. Manufacturers must also establish a post-market surveillance system and continuously update technical documentation. The MDR emphasizes confirming the effectiveness and safety of medical devices, requiring manufacturers to thoroughly assess clinical benefits and identify all potential health risks. The qualifications of professionals conducting clinical or preclinical evaluations must be documented, and the selection of literature sources must be transparent and clear.
The MDR also introduces the concepts of importer and distributor, which were not present in previous regulations. Authorized representatives, importers, and distributors are now required to verify compliance documents and retain technical documentation at their facilities. In addition to verifying and storing technical documentation, authorized representatives, distributors, and importers must actively participate in the manufacturer’s post-market surveillance system, promptly report complaints, and provide necessary information upon request from competent authorities.
Given these factors, the exact date for MDR implementation in Ukraine remains uncertain, as further development of legal and technical aspects is needed to align with EU regulations. It is also worth noting that the full implementation of MDR in the EU will take a total of 11 years, indicating the importance of allowing sufficient time for implementation. Even after this period, not all European manufacturers will transition to the new Regulation. Therefore, it is crucial to provide Ukrainian market operators and competent authorities with enough time to implement the new requirements to continue providing high-quality medical devices produced in Ukraine to consumers.
