MDR 2017/745 Specialist Skill

MDR 2017/745 Specialist

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

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

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

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 |

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

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 |

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)

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

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

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

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