Clinical Investigations and Performance Studies for Medical Devices and IVDs in Estonia

1. Clinical Evaluation and Investigations (Medical Devices - MDR)

Clinical evaluation is required to verify safety, performance, and clinical benefits, forming part of technical documentation before market placement. If existing data is insufficient, a clinical investigation is mandatory. Clinical investigations involve systematic studies on human subjects to assess safety or performance. Certain types (pre-CE marking, outside intended purpose, or substantial modifications) require an application to the State Agency of Medicines. Others (PMCF with additional burden) require notification. Source: Estonian State Agency of Medicines Clinical and Performance Studies Page https://www.ravimiamet.ee/en/medical-devices/medical-devices/clinical-and-performance-evaluation-and-studies

2. Performance Evaluation and Studies (IVDs - IVDR)

Performance evaluation justifies clinical evidence for conformity with safety and performance requirements. Performance studies are required if data is insufficient. Performance studies establish or confirm device performance. Applications are required for interventional studies, those with additional risks, companion diagnostics (except left-over samples only), or substantial modifications. Notifications apply to certain PMCF or left-over sample studies. Source: Estonian State Agency of Medicines Clinical and Performance Studies Page https://www.ravimiamet.ee/en/medical-devices/medical-devices/clinical-and-performance-evaluation-and-studies

3. Submission and Review Process

Submit a single application or notification to the State Agency of Medicines, which coordinates scientific and ethical evaluations. Ethical review is conducted by the Ethics Committee for Clinical Investigations (effective 1 October 2025). Fees include a state fee and an agency fee (details on Fees page). Source: Estonian State Agency of Medicines Clinical and Performance Studies Page https://www.ravimiamet.ee/en/medical-devices/medical-devices/clinical-and-performance-evaluation-and-studies

4. Reporting Obligations

Sponsors must submit a clinical/performance study report within one year of study end (or three months after early termination/halt in Estonia), accompanied by a layperson summary. Source: Estonian State Agency of Medicines Clinical and Performance Studies Page https://www.ravimiamet.ee/en/medical-devices/medical-devices/clinical-and-performance-evaluation-and-studies

5. National and EU Guidance

National requirements in Medical Devices Act §§ 21¹–22² supplement MDR/IVDR. Follow MDCG and European Commission guidance. Source: Estonian State Agency of Medicines Clinical and Performance Studies Page https://www.ravimiamet.ee/en/medical-devices/medical-devices/clinical-and-performance-evaluation-and-studies MDCG Guidance: https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en