Create EU MDR Project

INFO

The full narrative for this page — six evaluation pathways, Device Description as source of truth, and the rule that context files feed steps rather than CEP/CER generation — is currently maintained in the Chinese create-project guide. Read the Chinese clinical evaluation overview first. English translation will follow after that text is confirmed.

Overview

Create a project to start the EU MDR clinical evaluation workflow. After creation, the system guides you through 10 steps to generate CEP, CER, and DCR documents.

Steps

1. Click "Projects" in bottom navigation
2. Click "+ New Project"
3. Fill in project information:
   • Project name
   • Regulatory framework: EU MDR
   • Device name, classification (I/IIa/IIb/III)
   • Manufacturer name
   • Product description
4. Click "Create"

Project Dashboard

After creation, the dashboard shows:

• Project information
• Task list (add multiple workflow tasks)
• Document pipeline

Prerequisite: Device Description

Important Pre-step

Before starting the clinical evaluation workflow, it is recommended to complete the Device Description first. Structured information from the Device Description is automatically injected into multiple CEP/CER document sections (features, principles of operation, intended purpose, etc.), ensuring accuracy and consistency.

The Device Description module allows you to fill in structured device information:

• Features & Functions -- Technical features and core capabilities
• Configurations & Variants -- Different models and options
• Accessories -- Accompanying accessories and components
• Previous Generations / Similar Devices -- Prior versions and market equivalents
• Principles of Operation -- Technical working principles

How to fill:

• Manually fill each field
• Click "AI Fill" to automatically extract device information from uploaded context files

Context Files

Upload reference documents for AI to use:

• IFU / Technical specifications
• Design documents
• Existing clinical data
• Equivalent device information
• PDF / Word / Excel supported

TIP

Upload detailed device information documents. AI will extract key information for analysis in subsequent steps.

Available Tasks

Click "+ Add Task" to select a workflow:

Task Type	Description	Plans
Clinical Evaluation	10-step EU MDR CE workflow	All
Risk Management	ISO 14971 compliant RM	All
GSPR Compliance	Annex I compliance check	Pro/Max
PMS Plan	Post-market surveillance plan	Pro/Max
PMCF Plan	Clinical follow-up plan	Pro/Max
CE Update	Clinical evaluation update	Pro/Max
PMCF Report	PMCF evaluation report	Pro/Max
PSUR	Periodic safety update report	Pro/Max
Evidence Registry	Evidence traceability	Pro/Max
V&V Execution	Verification & validation	Pro/Max

Next Step

After creating a project, completing Device Description, and adding a Clinical Evaluation task, start the 10-step workflow:

→ Device Info (Step 1)