What is a clinical investigation?

A clinical investigation is a systematic study conducted in human subjects to assess the safety, performance, and effectiveness of a medical device. Unlike clinical evaluation, which relies on existing data, clinical investigations generate new clinical evidence that supports regulatory submissions and ensures patient safety.
Clinical investigations are essential for high-risk devices, innovative technologies, or devices with new intended uses.

Regulatory context

EU MDR 2017/745: Articles 62–82 establish requirements for conducting clinical investigations, including planning, conduct, reporting, and post-investigation obligations.ISO 14155: International standard for Good Clinical Practice (GCP) in medical device studies, covering study design, monitoring, and reporting.MDCG Guidance: Provides practical instructions on study design, equivalence assessment, and clinical evidence requirements (e.g., MDCG 2020-6, MDCG 2020-13).FDA (21 CFR Part 812 – Investigational Device Exemption, IDE): Governs clinical investigations in the United States, defining procedures for study approval, conduct, and reporting.Swiss Ordinance on Clinical Trials with Medical Devices (ClinO-MD, SR 810.306): Implements the EU Medical Device Regulation (MDR) into Swiss law, detailing requirements for clinical investigations of medical devices.

Documentation required for approval

Clinical Investigation Plan (CIP)
Investigator’s Brochure (IB)
Monitoring plan
Information for subjects and Informed Consent Form (ICF)
Case Report Form (CRF)
Investigation site selection report (qualification and rationale for selection)
Instruction for Use (IFU)
Labelling
Investigator Commitment
Agreements between the Sponsor, the Principal Investigator, the Sites and other organizations involved
Insurance certificates, if applicable
List of investigation sites and principal investigators
CVs of principal investigators and other members of the investigation site team
Manufacturer's declaration that the product complies with all GSPRs except those related to clinical research (for investigations conducted in Europe with products without CE marking)

Objectives of clinical investigations

Clinical investigations aim to:
● Demonstrate safety of the device in its intended use.
● Confirm clinical performance or effectiveness.
● Provide evidence for regulatory approval or clearance.
● Inform risk-benefit assessments and post-market planning.

Challenges and best practices

How we can help

We provide comprehensive support for clinical investigations, including:
● Clinical Investigation Plan and other documents development.
● Monitoring and oversight of clinical trials.
● Clinical Investigation Report drafting and regulatory reporting.
● Guidance on MDR, ClinO-MD, and ISO 14155 compliance.
Our expertise ensures that your clinical studies are robust, compliant, and aligned with regulatory expectations.