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Medical Device Registration in Ukraine: Conformity Assessment in Practice

Introduction: Regulatory framework behind market access

Since July 2015, medical devices and in vitro diagnostic devices placed on the Ukrainian market have been regulated under a conformity assessment system aligned with EU principles. Instead of a classical “registration” model, Ukraine applies technical regulations based on risk classification, conformity assessment routes, and manufacturer responsibility.

In practice, market access is granted through conformity assessment to applicable Technical Regulations, followed by the issuance of a Declaration of Conformity and affixing of the conformity marking on the device, its packaging, or instructions for use.

This system applies to both Ukrainian and foreign manufacturers and is mandatory for legal placing of medical devices on the market.

Applicable Technical Regulations in Ukraine

At present, medical devices in Ukraine are regulated by three Technical Regulations:

Each Technical Regulation defines:

  • risk classification rules;

  • applicable conformity assessment routes;

  • manufacturer obligations;

  • documentation and post-market requirements.

Role of the conformity marking and Declaration of Conformity

The conformity marking confirms that the manufacturer declares compliance with all applicable essential safety and performance requirements of the Technical Regulation.

This declaration:

  • is issued under manufacturer responsibility;

  • applies to the specific device and configuration;

  • confirms compliance with health, safety, and environmental requirements.

Authorized Representative (AR) in Ukraine

For foreign manufacturers, appointment of an Authorized Representative in Ukraine is mandatory.

Key requirements:

  • the AR must be a legal entity registered in Ukraine;

  • responsibilities are defined contractually;

  • regulatory responsibility remains with the manufacturer.

From a practical standpoint, separation of commercial distribution and regulatory representation is strongly recommended to avoid conflicts of interest and ensure regulatory independence.

Conformity assessment routes: general logic

The applicable conformity assessment route depends on:

  • device type (MD / IVD / AIMD);

  • risk class;

  • sterility, measuring function, or special characteristics.

The conformity assessment may involve:

  • manufacturer self-declaration (for limited low-risk cases);

  • notified body–like authorized conformity assessment bodies;

  • audits, technical file review, and, where applicable, testing.

Simplified conformity assessment (self-declaration)

A simplified route applies to:

  • Class I medical devices (non-sterile, non-measuring);

  • certain IVD devices not intended for self-testing and not included in List A or B.

Important limitation:
Self-declaration does not exempt the manufacturer from:

  • preparing a full technical file;

  • maintaining documentation in accordance with the Technical Regulation;

  • ensuring post-market compliance.

Conformity assessment routes for Class IIa and IIb medical devices

For Class IIa and IIb medical devices, conformity assessment involves authorized bodies and defined assessment modules.

Typical routes include combinations of:

  • Annex 3 (EC-type examination equivalent);

  • Annex 4 or Annex 5 (production or product quality assurance);

  • Annex 6 (product verification).

The exact route depends on:

  • device characteristics;

  • sterility or measuring function;

  • manufacturer’s quality system maturity.

Technical file: the core regulatory document

The technical file is the central document reviewed during conformity assessment.

It includes:

  • device description and intended purpose;

  • risk management documentation;

  • performance and safety data;

  • clinical or performance evaluation;

  • labeling and IFU;

  • quality system elements (where applicable).

The structure and depth of the technical file depend on the device risk class and selected conformity assessment route.

Practical timelines and complexity

In practice, conformity assessment timelines depend on:

  • device risk class;

  • quality of technical documentation;

  • availability of test reports and clinical evidence;

  • workload of the authorized body.

Typical timelines range from:

  • several weeks (simple Class I cases),

  • to several months (Class IIa / IIb and complex IVD systems).

What manufacturers often underestimate

Foreign manufacturers frequently underestimate:

  • preparation effort for technical documentation;

  • local regulatory nuances;

  • time needed for communication with conformity assessment bodies;

  • post-market surveillance obligations.

Early regulatory planning significantly reduces delays and compliance risks.

Our approach to conformity assessment in Ukraine

We provide end-to-end regulatory support for manufacturers entering the Ukrainian market, including:

  • regulatory strategy and device classification;

  • selection of optimal conformity assessment route;

  • Authorized Representative services in Ukraine;

  • preparation and review of technical documentation;

  • interaction with conformity assessment bodies;

  • audit support and resolution of non-conformities;

  • issuance of Declaration of Conformity.

Our focus is on predictable timelines, regulatory clarity, and practical market access, not formal compliance only.

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