CTD vs MDR: Documentation Requirements Compared

Introduction

The pharmaceutical and medical device industries have distinct regulatory frameworks with different documentation requirements. Understanding the differences between the Common Technical Document (CTD) for pharmaceuticals and the Medical Device Regulation (MDR) technical documentation is essential for companies working across both sectors.

Common Technical Document (CTD) for Pharmaceuticals

The CTD is an internationally harmonized format for preparing regulatory submissions for pharmaceutical products. It consists of five modules:

• Module 1: Regional administrative information
• Module 2: Common Technical Document summaries
• Module 3: Quality (Chemistry, Manufacturing, and Controls)
• Module 4: Nonclinical study reports
• Module 5: Clinical study reports

MDR Technical Documentation for Medical Devices

Under the EU Medical Device Regulation (MDR 2017/745), manufacturers must compile comprehensive technical documentation that demonstrates conformity with regulatory requirements. The structure includes:

• Device description and specifications
• Information supplied by the manufacturer
• Design and manufacturing information
• General safety and performance requirements
• Benefit-risk analysis and risk management
• Product verification and validation
• Clinical evaluation
• Post-market surveillance

Comparative Analysis

Clinical Evidence Requirements

CTD: Requires extensive clinical trial data with detailed Clinical Study Reports following ICH E3 guidelines. Emphasis on randomized controlled trials demonstrating efficacy and safety.

MDR: Clinical evaluation can include clinical investigations, literature reviews, and post-market clinical follow-up. Equivalence to existing devices may be demonstrated in some cases.

Quality Documentation

CTD Module 3: Detailed chemistry, manufacturing, and controls information including drug substance and drug product specifications, manufacturing processes, and stability data.

MDR: Design and manufacturing information including materials, manufacturing processes, quality management system, and compliance with harmonized standards (e.g., ISO 13485).

Risk Management

CTD: Risk management integrated into Module 2.5 (Clinical Overview) and Module 2.7 (Clinical Summary) as part of benefit-risk assessment.

MDR: Comprehensive risk management file required following ISO 14971, with detailed risk analysis, evaluation, and control measures as a standalone section.

Post-Market Requirements

CTD: Post-marketing data included in periodic safety update reports (PSURs) and risk management plans (RMPs), submitted separately from the initial CTD.

MDR: Post-market surveillance plan and post-market clinical follow-up plan must be included in the initial technical documentation and continuously updated.

Similarities

• Both require comprehensive safety and performance data
• Both emphasize risk-benefit analysis
• Both require quality management system documentation
• Both need to demonstrate compliance with applicable standards
• Both require ongoing post-market monitoring

Practical Implications

For Combination Products

Products that combine drugs and devices (e.g., drug-eluting stents, prefilled syringes) must address requirements from both frameworks. The primary mode of action determines which regulation takes precedence, but documentation must satisfy both sets of requirements.

For Companies Working Across Sectors

Organizations operating in both pharmaceutical and medical device sectors should:

• Develop expertise in both regulatory frameworks
• Establish separate but coordinated documentation processes
• Leverage common elements (e.g., quality systems, risk management)
• Ensure teams understand the distinct requirements