Clinical Evaluation of Medical Devices in Ukraine: Are Clinical Trials Really Necessary?

All medical devices intended for placing on the market in Ukraine or the EU must undergo clinical evaluation. This does not necessarily mean conducting clinical trials — in most cases, it is sufficient to gather existing evidence of safety and performance based on scientific literature, regulatory standards, and real-world use.

What is clinical evaluation?

A Clinical Evaluation Report (CER) is a document summarizing all available clinical data that confirms the safety and performance of a medical device according to its intended purpose.

Requirements for CER are defined in:

• Technical Regulation No. 753 (classification and conformity assessment),

• MDR 2017/745 (Annex XIV),

• MEDDEV 2.7/1 Rev.4 — a key guidance document for CER structure and content.

Who needs a CER?

• Manufacturers placing Class I, IIa, IIb or III devices on the market;

• Importers submitting technical documentation on behalf of manufacturers;

• Developers of medical software;

• Manufacturers without their own clinical trials.

Clinical evaluation is especially important for devices with new indications, modified design, or features affecting patient safety.

What does the CER include?

• Defining intended use and risk class of the device;

• Systematic literature review (PubMed, WHO, EUDAMED);

• Equivalence analysis (or justification of its absence);

• Summary of relevant clinical data;

• Benefit-risk assessment;

• Final conclusion regarding conformity.

PMS and PMCF: What’s the status in Ukraine?

Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) are mandatory components of clinical evaluation under MDR.

In Ukraine, there are currently no strict local requirements for PMS or PMCF. However, European and international manufacturers usually include these elements in their technical files based on global practices and standards (e.g., ISO 13485, ISO 14155).

Ukrainian manufacturers and importers should also consider PMS and PMCF, especially when planning to enter EU markets or build a comprehensive technical dossier.

How we can help

We are not a clinical facility or hospital authorized to conduct full-scale clinical trials.

However, we specialize in preparing Clinical Evaluation Reports (CER) based on literature data, equivalence analysis, and post-market experience.

We also work directly with foreign manufacturers planning to enter the Ukrainian market or prepare documentation under MDR.

We help:

• Assess whether available data is sufficient to prepare a CER without additional studies;

• Conduct scientific literature searches (PubMed, WHO, etc.);

• Adapt reports in line with MDR, MEDDEV, and Technical Regulation No. 753;

• Provide justifications for the absence of PMCF, where appropriate;

• Prepare CERs for submission by importers or authorized representatives.

Approximate pricing is available in the Services & Prices section.

Summary

Clinical evaluation is not a formality — it’s the foundation of a solid technical file. Even if you don’t have your own clinical trials, a well-prepared CER can meet the requirements in both Ukraine and the EU.

We’ll help you find the best strategy — no matter the risk class of your device.