Medical Device Regulation in Ukraine: Preparing for MDR and IVDR in 2025–2026

In 2025, Ukraine is actively preparing for a major reform of its regulatory framework for medical devices. The main objective is to align national legislation with the provisions of the EU Regulations 2017/745 (MDR) and 2017/746 (IVDR). For manufacturers and suppliers entering the Ukrainian market, this means new classification rules, updated technical documentation, digital registration, and the introduction of UDI labelling.

⚙️ Current Regulation and the Need for Change

As of now, Ukraine applies three main Technical Regulations:

• Technical Regulation on Medical Devices (CMU Resolution No. 753 of October 2, 2013);
• Technical Regulation on In Vitro Diagnostic Medical Devices (Resolution No. 754);
• Technical Regulation on Active Implantable Medical Devices (Resolution No. 755).

These regulations were originally based on EU Directives from the 1990s (MDD, AIMDD, IVDD), which have already been replaced in the EU. Ukraine now faces the challenge of fully updating its legislation to reflect modern EU standards.

🇪🇺 What Are MDR and IVDR — and Why They Matter

The EU Regulations 2017/745 (MDR) and 2017/746 (IVDR) establish a new regulatory framework with stricter requirements for:

• risk classification of devices;
• clinical evaluation and post-market surveillance;
• UDI (Unique Device Identification) labelling;
• digital registration of manufacturers and devices in the EUDAMED system.

As a candidate for EU membership, Ukraine is expected to gradually harmonize its national legislation with these European regulations. Drafts are already under discussion among national working groups.

🔄 Expected Changes in 2025–2026

1. New Technical Regulations Based on MDR/IVDR

According to Ukraine’s Ministry for Economy, new Technical Regulations are in development to replace current Resolutions No. 753, 754, and 755. Key changes are expected to include:

• updated classification rules (e.g. most IVDs will move from Class A to B/C/D);
• new requirements for labelling and IFU;
• mandatory post-market reporting (PMS);
• creation of a national electronic database for medical devices.

Draft texts have not yet been published. However, discussions are ongoing within the national Technical Committee 141 and working groups under the Ministry of Health.

2. National Registry for Medical Devices

The Ministry of Health and the State Expert Center are developing a national registry for IVDs, starting with Class A and B devices. A pilot version is already in use for selected product categories, especially those listed on Prozorro Market. This registry is expected to support automated verification during public procurement.

3. Implementation of UDI Labelling

UDI (Unique Device Identification) is under active review since 2024. Preliminary plans indicate:

• mandatory UDI labelling for Classes C and D beginning 2026–2027;
• creation of a Ukrainian UDI database or linkage to EUDAMED;
• updated labelling and packaging requirements.

UDI is a critical tool for traceability, anti-counterfeiting, and patient safety.

⚠️ Key Risks for Manufacturers and Importers

1. Reclassification of Products
   Many Class 1 or Class A devices may be reclassified under the new system, requiring notified body involvement.
2. Lack of MDR/IVDR Certification
   Many Chinese and Indian manufacturers still lack MDR/IVDR certificates, which may limit market access once the new system is implemented.
3. Digital Documentation Requirements
   Suppliers will need to register products in a national database and provide compliant digital documentation.
4. Tender Restrictions
   Without updated certificates or registration, access to public procurement may be restricted.

✅ Recommendations for Suppliers

• Update your technical documentation to meet MDR/IVDR standards, even before the new regulations are adopted in Ukraine.
• Verify UDI labelling: ensure that your product uses MDR/IVDR-compliant UDI format, especially for higher-risk classes.
• Monitor official updates from the Ministry of Health, Ministry for Economy, and the State Expert Center.
• In the long term: if your product is already marketed in the EU, it is advisable (but not yet mandatory) to ensure it is registered in the EUDAMED database — this may become an advantage in future harmonized systems.

🔚 Conclusion

Ukraine is on the verge of a significant transformation in the regulation of medical devices. The transition to MDR/IVDR-based legislation in 2025–2026 will bring updated classification rules, post-market obligations, UDI labelling, and digital verification.

Proactive preparation will allow manufacturers to maintain access to the Ukrainian market and remain competitive under the new regulatory environment. Suppliers are advised to act now — adapt documentation, ensure proper labelling, and stay informed on upcoming changes.