MDR 2017/745 Specialist

EU MDR compliance patterns for medical device classification, technical documentation, and clinical evidence.

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Table of Contents

• Device Classification Workflow
• Technical Documentation
• Clinical Evidence
• Post-Market Surveillance
• EUDAMED and UDI
• Reference Documentation
• Tools

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Device Classification Workflow

Classify device under MDR Annex VIII:

• Identify device duration (transient, short-term, long-term)
• Determine invasiveness level (non-invasive, body orifice, surgical)
• Assess body system contact (CNS, cardiac, other)
• Check if active device (energy dependent)
• Apply classification rules 1-22
• For software, apply MDCG 2019-11 algorithm
• Document classification rationale
• Validation: Classification confirmed with Notified Body

Classification Matrix

| Factor | Class I | Class IIa | Class IIb | Class III |

|--------|---------|-----------|-----------|-----------|

| Duration | Any | Short-term | Long-term | Long-term |

| Invasiveness | Non-invasive | Body orifice | Surgical | Implantable |

| System | Any | Non-critical | Critical organs | CNS/cardiac |

| Risk | Lowest | Low-medium | Medium-high | Highest |

Software Classification (MDCG 2019-11)

| Information Use | Condition Severity | Class |

|-----------------|-------------------|-------|

| Informs decision | Non-serious | IIa |

| Informs decision | Serious | IIb |

| Drives/treats | Critical | III |

Classification Examples

Example 1: Absorbable Surgical Suture

• Rule 8 (implantable, long-term)
• Duration: > 30 days (absorbed)
• Contact: General tissue
• Classification: Class IIb

Example 2: AI Diagnostic Software

• Rule 11 + MDCG 2019-11
• Function: Diagnoses serious condition
• Classification: Class IIb

Example 3: Cardiac Pacemaker

• Rule 8 (implantable)
• Contact: Central circulatory system
• Classification: Class III

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Technical Documentation

Prepare technical file per Annex II and III:

• Create device description (variants, accessories, intended purpose)
• Develop labeling (Article 13 requirements, IFU)
• Document design and manufacturing process
• Complete GSPR compliance matrix
• Prepare benefit-risk analysis
• Compile verification and validation evidence
• Integrate risk management file (ISO 14971)
• Validation: Technical file reviewed for completeness

Technical File Structure

ANNEX II TECHNICAL DOCUMENTATION
├── Device description and UDI-DI
├── Label and instructions for use
├── Design and manufacturing info
├── GSPR compliance matrix
├── Benefit-risk analysis
├── Verification and validation
└── Clinical evaluation report

GSPR Compliance Checklist

| Requirement | Evidence | Status |

|-------------|----------|--------|

| Safe design (GSPR 1-3) | Risk management file | ☐ |

| Chemical properties (GSPR 10.1) | Biocompatibility report | ☐ |

| Infection risk (GSPR 10.2) | Sterilization validation | ☐ |

| Software requirements (GSPR 17) | IEC 62304 documentation | ☐ |

| Labeling (GSPR 23) | Label artwork, IFU | ☐ |

Conformity Assessment Routes

| Class | Route | NB Involvement |

|-------|-------|----------------|

| I | Annex II self-declaration | None |

| Is/Im | Annex II + IX/XI | Sterile/measuring aspects |

| IIa | Annex II + IX or XI | Product or QMS |

| IIb | Annex IX + X or X + XI | Type exam + production |

| III | Annex IX + X | Full QMS + type exam |

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Clinical Evidence

Develop clinical evidence strategy per Annex XIV:

• Define clinical claims and endpoints
• Conduct systematic literature search
• Appraise clinical data quality
• Assess equivalence (technical, biological, clinical)
• Identify evidence gaps
• Determine if clinical investigation required
• Prepare Clinical Evaluation Report (CER)
• Validation: CER reviewed by qualified evaluator

Evidence Requirements by Class

| Class | Minimum Evidence | Investigation |

|-------|------------------|---------------|

| I | Risk-benefit analysis | Not typically required |

| IIa | Literature + post-market | May be required |

| IIb | Systematic literature review | Often required |

| III | Comprehensive clinical data | Required (Article 61) |

Clinical Evaluation Report Structure

CER CONTENTS
├── Executive summary
├── Device scope and intended purpose
├── Clinical background (state of the art)
├── Literature search methodology
├── Data appraisal and analysis
├── Safety and performance conclusions
├── Benefit-risk determination
└── PMCF plan summary

Qualified Evaluator Requirements

• Medical degree or equivalent healthcare qualification
• 4+ years clinical experience in relevant field
• Training in clinical evaluation methodology
• Understanding of MDR requirements

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Post-Market Surveillance

Establish PMS system per Chapter VII:

• Develop PMS plan (Article 84)
• Define data collection methods
• Establish complaint handling procedures
• Create vigilance reporting process
• Plan Periodic Safety Update Reports (PSUR)
• Integrate with PMCF activities
• Define trend analysis and signal detection
• Validation: PMS system audited annually

PMS System Components

| Component | Requirement | Frequency |

|-----------|-------------|-----------|

| PMS Plan | Article 84 | Maintain current |

| PSUR | Class IIa and higher | Per class schedule |

| PMCF Plan | Annex XIV Part B | Update with CER |

| PMCF Report | Annex XIV Part B | Annual (Class III) |

| Vigilance | Articles 87-92 | As events occur |

PSUR Schedule

| Class | Frequency |

|-------|-----------|

| Class III | Annual |

| Class IIb implantable | Annual |

| Class IIb | Every 2 years |

| Class IIa | When necessary |

Serious Incident Reporting

| Timeline | Requirement |

|----------|-------------|

| 2 days | Serious public health threat |

| 10 days | Death or serious deterioration |

| 15 days | Other serious incidents |

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EUDAMED and UDI

Implement UDI system per Article 27:

• Obtain issuing entity code (GS1, HIBCC, ICCBBA)
• Assign UDI-DI to each device variant
• Assign UDI-PI (production identifier)
• Apply UDI carrier to labels (AIDC + HRI)
• Register actor in EUDAMED
• Register devices in EUDAMED
• Upload certificates when available
• Validation: UDI verified on sample labels

EUDAMED Modules

| Module | Content | Actor |

|--------|---------|-------|

| Actor | Company registration | Manufacturer, AR |

| UDI/Device | Device and variant data | Manufacturer |

| Certificates | NB certificates | Notified Body |

| Clinical Investigation | Study registration | Sponsor |

| Vigilance | Incident reports | Manufacturer |

| Market Surveillance | Authority actions | Competent Authority |

UDI Label Requirements

Required elements per Article 13:

• [ ] UDI-DI (device identifier)
• [ ] UDI-PI (production identifier) for Class II+
• [ ] AIDC format (barcode/RFID)
• [ ] HRI format (human-readable)
• [ ] Manufacturer name and address
• [ ] Lot/serial number
• [ ] Expiration date (if applicable)

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Reference Documentation

MDR Classification Guide

references/mdr-classification-guide.md contains:

• Complete Annex VIII classification rules (Rules 1-22)
• Software classification per MDCG 2019-11
• Worked classification examples
• Conformity assessment route selection

Clinical Evidence Requirements

references/clinical-evidence-requirements.md contains:

• Clinical evidence framework and hierarchy
• Literature search methodology
• Clinical Evaluation Report structure
• PMCF plan and evaluation report guidance

Technical Documentation Templates

references/technical-documentation-templates.md contains:

• Annex II and III content requirements
• Design History File structure
• GSPR compliance matrix template
• Declaration of Conformity template
• Notified Body submission checklist

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Tools

MDR Gap Analyzer

# Quick gap analysis
python scripts/mdr_gap_analyzer.py --device "Device Name" --class IIa

JSON output for integration
python scripts/mdr_gap_analyzer.py --device "Device Name" --class III --output json

Interactive assessment
python scripts/mdr_gap_analyzer.py --interactive

Analyzes device against MDR requirements, identifies compliance gaps, generates prioritized recommendations.

Output includes:

• Requirements checklist by category
• Gap identification with priorities
• Critical gap highlighting
• Compliance roadmap recommendations

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Notified Body Interface

Selection Criteria

| Factor | Considerations |

|--------|----------------|

| Designation scope | Covers your device type |

| Capacity | Timeline for initial audit |

| Geographic reach | Markets you need to access |

| Technical expertise | Experience with your technology |

| Fee structure | Transparency, predictability |

Pre-Submission Checklist

• [ ] Technical documentation complete
• [ ] GSPR matrix fully addressed
• [ ] Risk management file current
• [ ] Clinical evaluation report complete
• [ ] QMS (ISO 13485) certified
• [ ] Labeling and IFU finalized
• [ ] Validation: Internal gap assessment complete