I’m not sure whether my project qualifies as a clinical trial, a medical experiment, or an observational study.

This is a very common situation — especially in innovative projects situated between clinical research and real-world practice, where the boundaries between a clinical trial, an experiment and an observational study can be unclear.

At Biostat®, we help sponsors, clinicians and researchers precisely determine the status and category of the project so that the correct regulatory pathway is selected from the outset, avoiding formal errors and accelerating the process of obtaining required approvals.

Every medical project can be assigned to one of several regulatory categories. We help identify whether your study is:

• A clinical trial of a medicinal product — conducted under EU Regulation 536/2014, requiring approval from both the Bioethics Committee and URPL. This applies to active substances, investigational medicinal products or new indications.
• A clinical investigation of a medical device — regulated by MDR 2017/745, requiring Bioethics Committee approval and notification to URPL. This includes both pre-market and post-market clinical follow-up studies.
• A medical research experiment — defined in the Polish Act on the Medical Profession. It verifies new diagnostic, therapeutic or preventive methods. Requires Bioethics Committee approval, but not URPL notification.
• An observational (non-interventional) study — conducted without altering the treatment process. Requires a Bioethics Committee opinion and full GDPR compliance, but does not require URPL approval.
• A survey-based project, registry or retrospective data analysis — typically follows a simplified regulatory pathway and often requires only a Bioethics Committee opinion if data are anonymised.

You only need to provide a short description of the study objective, target population and data to be collected. We then prepare a full classification and recommend the required regulatory pathway.
This prevents situations in which the application is “blocked” or returned by the Bioethics Committee or URPL due to incorrect classification.

As part of the service, we also precisely determine:

• the clinical trial phase (I–IV) — based on product development stage, study objective and participant profile,
• the medical device class (I–III) — according to Annex VIII of MDR 2017/745,
• whether the device study is pre-market or post-market (PMCF).

For borderline cases — e.g., uncertainty whether the study involves therapeutic intervention or only observation — we prepare a classification report or legal opinion. This document may be attached to the Bioethics Committee submission or presented during consultations with URPL.

Such an analysis is based on binding regulations (EU Regulation 536/2014, MDR 2017/745, Pharmaceutical Law Act, Medical Devices Act).
It provides formal confirmation of correct classification and facilitates the approval process.

In practice, this means you do not need to independently analyse legal definitions or interpret complex regulations.
Biostat® does it for you — providing a clear classification, recommended regulatory path and ready materials to speed up ethics and administrative approvals.