What Are Clinical Trials of Medical Devices?

Clinical trials of medical devices are structured scientific processes involving human participants to confirm the safety, effectiveness, and performance of a device under real clinical conditions. According to MDR 2017/745, they are termed “clinical investigations” and are an integral part of the clinical evaluation required to obtain CE marking. This requirement especially applies to innovative devices and those in higher-risk classes.

Why Are Clinical Trials Required?

Demonstrating safety and effectiveness based on clinical data is a core requirement of MDR certification. These data form the basis not only for market approval but also for post-market surveillance (PMS) and PMCF. Clinical investigations also support the technical documentation and clinical evaluation, impacting PSUR reports.

Types of Clinical Investigations for Medical Devices

  • Efficacy and safety investigations – validate intended use and assess risk profile.
  • Feasibility studies – planned based on a feasibility analysis of patients, sites, and resources.
  • IVD performance studies – follow the guidelines for IVD performance investigations, focusing on diagnostic parameters such as sensitivity and specificity.
  • PMCF studies – post-market clinical follow-up investigations.

Roles of Sponsor, Investigator, and CRO

The sponsor is responsible for designing, funding, conducting, and overseeing the clinical investigation—typically the manufacturer. The investigator leads the study at the site and ensures patient safety. The Contract Research Organization (CRO) is a third party the sponsor may delegate tasks to—such as monitoring, audits, and data management—under ISO 14155 documentation.

Planning a Clinical Investigation

Planning begins with the protocol, including inclusion/exclusion criteria, endpoints, statistical analysis strategy, and timeline. The study must comply with clinical investigation design principles, including endpoint definitions, population criteria, and statistical methodology.

Study Registration and EUDAMED

Every clinical investigation must be registered in EUDAMED and submitted to the national competent authority (URPL in Poland). Required documents include the protocol, investigator’s brochure, risk management plan, informed consent forms, and liability insurance. The study may only commence after ethics committee approval and absence of objections from the authority.

Site Selection and Audit

Site selection depends on team experience, patient availability, and GCP compliance. A qualification audit must precede site activation, evaluating infrastructure, staff, documentation systems, and ISO 14155 compliance. Selection must follow site requirements.

Investigator Qualifications

Investigators must have appropriate professional qualifications and current GCP training. Training documentation should be retained by the sponsor and verified before trial initiation.

Clinical Investigation Conduct

This includes patient recruitment, site visits, protocol adherence, and data management using EDC systems. Data integrity, subject protection, and adverse event analysis are monitored by the sponsor and CRO. Monitoring is a key component of quality oversight, aligned with GCP, MDR, and ISO 14155.

Incident Reporting and Corrective Actions

In the event of a serious incident (SAE/SUSAR), the sponsor must report it to authorities within 7 days (MDR Article 80) and implement CAPA, which may require protocol or ICF updates.

Statistical Analysis

Clinical data must be analyzed per a pre-defined statistical analysis plan (SAP). Analysis sets like FAS, PPS, and SAF must be selected, and missing data addressed per ISO 14155 and MDR requirements. Statistical accuracy impacts data interpretability.

Study Documentation

Required documents include the protocol, informed consent form (ICF), case report form (CRF), investigator’s brochure, monitoring lists, visit reports, adverse event logs, and the final study report. Proper medical writing is critical to meet MDR, GCP, and ISO 14155 standards.

Results Reporting and CIR

Upon study completion, the sponsor prepares the Clinical Investigation Report (CIR), detailing methods, results, adverse events, and conclusions. This is submitted to EUDAMED and the competent authority. A high-quality clinical investigation report influences notified body review outcomes.

Each study must be ethics committee-approved, and subjects must sign informed consent. The process must comply with MDR and the Declaration of Helsinki. Participants may withdraw at any time without giving reasons.

Clinical investigation outcomes support PMS and PMCF as defined in MDR Annex XIV. Lack of integration leads to rejection of the clinical evaluation.

How Pure Clinical Supports Clinical Investigations

Pure Clinical offers end-to-end support for clinical investigations in line with MDR, ISO 14155, and GCP:

  • Protocol and EUDAMED documentation development,
  • Feasibility analysis and site auditing,
  • Monitoring, data management, SAE/SUSAR reporting,
  • Preparation of final documentation and CIR,
  • Integration of results with PMS and PMCF.

Our team combines CRO expertise, operational know-how, and regulatory insight to support manufacturers in delivering the clinical evidence required by notified bodies.