# EU MDR 2017/745 Submission Guide

## MDR Classification and Conformity Assessment Routes

### Class I Devices
- **Self-certification** under Annex II
- **Technical documentation** requirements per Annex II
- **Declaration of Conformity** mandatory
- **UDI registration** required

### Class IIa Devices
- **Notified Body involvement** for Annex III Module C2 + Annex V
- **Quality management system** assessment
- **Technical documentation** review
- **Ongoing surveillance** requirements

### Class IIb Devices
- **Notified Body certification** under Annex III Module B + C or D
- **Type examination** or **Full quality assurance** route
- **Design examination** requirements
- **Production surveillance** obligations

### Class III Devices
- **Comprehensive Notified Body assessment**
- **Type examination** + production surveillance OR
- **Full quality assurance** system approach
- **Design dossier** requirements per Annex II

## Key MDR Submission Requirements

### 1. Technical Documentation (Annex II)
- Device description and intended purpose
- Risk management documentation (ISO 14971)
- Clinical evidence per Annex XIV
- Post-market surveillance plan
- Performance evaluation reports

### 2. Quality Management System (Annex I, Chapter II)
- ISO 13485 compliant QMS
- Design controls implementation
- Risk management integration
- Clinical evaluation procedures
- Post-market surveillance system

### 3. Clinical Evidence Requirements
- **Clinical evaluation plan** per Annex XIV
- **Literature review** and gap analysis
- **Clinical investigation** if required
- **Post-market clinical follow-up** plan
- **Clinical evaluation report** updating

### 4. UDI System Implementation
- **UDI-DI assignment** and registration
- **UDI-PI requirements** for higher risk devices
- **EUDAMED registration** obligations
- **Labeling compliance** with UDI requirements

## Submission Timeline Framework

### Pre-Submission Phase (6-12 months)
1. **Gap analysis** against MDR requirements
2. **Classification confirmation** with regulatory experts
3. **Notified Body selection** and preliminary discussions
4. **Clinical evidence strategy** development
5. **UDI strategy** and EUDAMED preparation

### Submission Preparation (3-6 months)
1. **Technical documentation** compilation
2. **QMS documentation** review and update
3. **Clinical evaluation** completion
4. **Risk management** file finalization
5. **Notified Body application** submission

### Review and Certification (6-18 months)
1. **Initial assessment** by Notified Body
2. **Questions and clarifications** response
3. **Audit activities** coordination
4. **Certificate issuance** and market access
5. **Post-market obligations** activation

## Critical Success Factors

- **Early engagement** with chosen Notified Body
- **Robust clinical evidence** strategy and execution
- **Comprehensive risk management** throughout lifecycle
- **Proactive post-market surveillance** system
- **Regular monitoring** of regulatory updates and guidance

## Common Pitfalls to Avoid

- **Insufficient clinical evidence** planning
- **Late Notified Body engagement**
- **Inadequate post-market surveillance** systems
- **Poor documentation quality** and traceability
- **Underestimating timeline** and resource requirements
