The Role of Documentation in MDR-Compliant Clinical Investigations
Proper documentation is the backbone of every clinical investigation. Under MDR (EU 2017/745) and ISO 14155, medical device manufacturers are required to maintain a comprehensive set of documents to demonstrate the safety and clinical performance of their devices. These documents ensure that the investigation is conducted ethically, scientifically, and in line with all applicable regulations.
As a Contract Research Organization (CRO), MDS supports manufacturers through every step of this process—ensuring that all documentation is accurate, complete, and ready for submission to ethics committees and regulatory authorities.
Key Documents in a Clinical Investigation
A successful clinical investigation depends on a set of essential documents, each playing a distinct and critical role:
The Clinical Investigation Plan (CIP) outlines the study’s methodology, objectives, inclusion/exclusion criteria, and data analysis strategy. It acts as the roadmap for your clinical trial, aligning every step of the investigation with regulatory and ethical requirements.
The Investigator’s Brochure (IB) compiles all available clinical and non-clinical data about the investigational device. It provides investigators with detailed information about how the device functions, its intended use, and its risk profile.
The Informed Consent Form (ICF) ensures that participants fully understand the purpose of the investigation, its potential risks and benefits, and their rights as study subjects. It must be signed before participation begins, reflecting voluntary and informed agreement.
Case Report Forms (CRFs) or electronic Case Report Forms (eCRFs) are used to capture clinical data during the study. These forms ensure accurate and consistent documentation of all findings in accordance with the CIP.
Why Documentation Matters
Each document contributes to the overall integrity and compliance of the clinical investigation. Without clear, properly maintained documentation, a study may fail to meet regulatory expectations, delaying approvals and placing the entire project at risk. Moreover, well-prepared documentation supports the transparency, reproducibility, and ethical standards that define good clinical practice.
How MDS Supports Clinical Documentation
At MDS, we assist medical device companies in preparing and managing all required documents for their clinical investigations. Our team ensures that every document:
- Meets current MDR and ISO 14155 standards
- Is aligned with the approved clinical protocol
- Is audit-ready and traceable throughout the study lifecycle
We take on the complexity so you can focus on the clinical and commercial success of your device.
In our next post
We’ll be taking a look at site selection, regulatory approvals, and monitoring—all critical components in preparing and executing a successful clinical investigation!