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

All medical devices intended for placing on the Ukrainian or EU market must undergo clinical evaluation. This does not always mean conducting a clinical trial — in most cases, it is enough to collect existing evidence of safety and performance from literature, standards, and use experience.

What is Clinical Evaluation?

Clinical Evaluation Report (CER) is a document summarizing all clinical evidence demonstrating 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 — the key guideline for CER structure and content.

Who Needs a CER?

• Manufacturers registering a Class 1, 2a, 2b, or 3 device;

• Importers submitting the manufacturer’s technical documentation;

• Software manufacturers;

• Manufacturers without their own clinical trials.

Clinical evaluation is especially important if the device has a new intended use, modified design, or functions affecting patient safety.

What Does Clinical Evaluation Include?

• Determining intended use and risk class;

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

• Equivalence analysis (or its absence);

• Summarizing published data;

• Assessing benefit-risk ratio;

• Concluding on market acceptability.

PMS and PMCF — What About Ukraine?

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

Ukraine currently lacks clear national requirements for such reports. However, European and international manufacturers usually include these elements in their technical files following their own practice and standards (e.g. ISO 13485 or ISO 14155).

Ukrainian manufacturers and importers should also consider PMS/PMCF, especially if they plan to enter foreign markets or want to build a complete technical dossier.

How We Help

We are not a clinical facility or medical center conducting full-scale clinical trials.

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

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

We help:

• Assess whether existing data is sufficient for a CER without new trials;

• Conduct systematic searches and analysis (PubMed, WHO, guidance);

• Adapt the report to MDR, MEDDEV, and Technical Regulation No. 753 requirements;

• Justify the absence of PMCF where applicable;

• Prepare a CER for submission by an importer or Authorized Representative.

Approximate prices — see the “Prices” section.

Summary

Clinical evaluation is not just a formality but the foundation of the technical documentation. Even without your own clinical trials, you can prepare a full CER accepted in Ukraine and the EU.

We help you develop the optimal strategy, regardless of device risk class.