The entry of Ukrainian medical device manufacturers into the European market and the MDR 2017/745 Regulation.
Entering the European market for medical devices is an opportunity to expand business and gain access to a market with a total turnover of more than 160 billion dollars. Ukrainian medical device manufacturers who aim to enter the European market must consider the requirements established by the MDR 2017/745 (Medical Device Regulation). Particular attention should be paid to the certification procedures, which vary depending on the risk class of the medical device.
Risk Level and Certification Procedures According to MDR
According to the MDR Regulation, medical devices are divided into different risk classes — from I to III. Low-risk medical devices (e.g., traditional Class I medical devices) may have the opportunity to enter the European market through a self-declaration procedure, where the manufacturer ensures the device’s compliance independently, without the involvement of notified bodies.
Medium and high-risk medical devices (Classes Is, Im, Ir, IIa, IIb, III) are subject to stricter certification requirements involving a notified body. To obtain a conformity certificate according to the MDR 2017/745 Regulation, the manufacturer must undergo an audit by the notified body, including an on-site visit by auditors.
After determining the risk class and the upcoming conformity assessment procedure, it is necessary to implement several requirements provided by the MDR Regulation. These relate to production, applicable standards and testing, technical documentation, registration in the EUDAMED database, and the implementation of unique device identification (UDI).
The Role of Registration in the EUDAMED Database
EUDAMED is a European database for medical devices where all market operators—manufacturers, authorized representatives, importers, and distributors—must register. This database facilitates the exchange of information between market participants and competent authorities and allows for the tracking and monitoring of medical devices placed on the market within the European Union. Class I risk medical devices can enter the European market through a self-declaration procedure. However, despite this, registration in EUDAMED and the generation of UDI codes remain mandatory.
Unique Device Identifier (UDI)
In addition to registration in the EUDAMED database, the manufacturer must assign a unique device identifier (UDI) to each medical device introduced to the market, which allows for the identification and tracking of medical devices. This is necessary to ensure traceability, enhance market operators’ compliance, and prevent counterfeit medical devices from entering the market. The UDI code consists of an identifier for a group or subgroup of medical devices and a unique identification for each released batch or series of products.
The Role of the Authorized Representative in the European Union
Every manufacturer not located within the European Union must have an authorized representative who represents the manufacturer’s interests within the EU. The MDR Regulation states that “an authorized representative is any natural or legal person established within the European Union who has received and accepted a written mandate from a manufacturer located outside the EU to act on the manufacturer’s behalf in connection with specific tasks related to the manufacturer’s obligations under the Regulation.” Typically, authorized representatives handle consumer complaints in the market, participate actively in post-marketing, and provide information upon request from competent authorities. However, in the context of a Ukrainian medical device manufacturer’s entry into the EU market, their role is even more critical, as the authorized representative must also be registered in the EUDAMED database. To successfully enter the EU market, it is necessary to select a competent and experienced authorized representative who can provide the necessary support throughout the certification process, which, incidentally, can take more than a year.
This is only part of the requirements that need to be met before starting the certification process for medical devices with a notified body or entering the market through the self-declaration procedure. But then a logical question arises: how to prepare for entering the EU market? After all, when Ukraine joins the European Union, these requirements will also apply to the Ukrainian market.
Below are some recommendations for a successful entry into the EU market.
Thorough Planning: Consider entering the European market as a separate project. Download the Regulation, compare it with the requirements of the Ukrainian Technical Regulation, and approve an implementation plan. Conduct an internal audit at the enterprise to identify which quality system points need to be updated.
Cooperation with Authorized Representatives: The choice of an authorized representative determines the speed of your market entry since during registration in the EUDAMED database, you must already have an authorized representative who confirms in the system that you have signed a contract with them. According to the MDR Regulation, the authorized representative is obliged to verify the availability and content of the technical documentation.
Updating Technical Documentation: The regulation requires maintaining the technical documentation in an up-to-date state to ensure the effectiveness and safety of medical devices for patients. This includes: a description of the device, its modifications, a list of applicable standards, preclinical testing for biocompatibility, shelf life, and electrical safety (if the medical device is active). It is also worth reviewing the availability of sufficient clinical evidence of the medical device’s effectiveness and safety and checking the qualifications of the personnel who conducted the information search in scientometric databases.
To successfully enter the European market, a Ukrainian manufacturer must also develop a strategy that considers not only competitiveness and consumer needs but also ensures the most effective and safe medical device, taking into account all applicable regulatory requirements. Entering the European market for Ukrainian medical device manufacturers requires strict adherence to certification requirements, compliance with standards provided by the MDR 2017/745 Regulation. Understanding the requirements and procedures will be a key factor for successfully entering the European medical device market, considering their risk class.
