mdr-745-specialist

MDR 2017/745 Specialist

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

---

Table of Contents

• 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:

1. Identify device duration (transient, short-term, long-term)
2. Determine invasiveness level (non-invasive, body orifice, surgical)
3. Assess body system contact (CNS, cardiac, other)
4. Check if active device (energy dependent)
5. Apply classification rules 1-22
6. For software, apply MDCG 2019-11 algorithm
7. Document classification rationale
8. 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:

1. Create device description (variants, accessories, intended purpose)
2. Develop labeling (Article 13 requirements, IFU)
3. Document design and manufacturing process
4. Complete GSPR compliance matrix
5. Prepare benefit-risk analysis
6. Compile verification and validation evidence
7. Integrate risk management file (ISO 14971)
8. 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:

1. Define clinical claims and endpoints
2. Conduct systematic literature search
3. Appraise clinical data quality
4. Assess equivalence (technical, biological, clinical)
5. Identify evidence gaps
6. Determine if clinical investigation required
7. Prepare Clinical Evaluation Report (CER)
8. 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:

1. Develop PMS plan (Article 84)
2. Define data collection methods
3. Establish complaint handling procedures
4. Create vigilance reporting process
5. Plan Periodic Safety Update Reports (PSUR)
6. Integrate with PMCF activities
7. Define trend analysis and signal detection
8. 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:

1. Obtain issuing entity code (GS1, HIBCC, ICCBBA)
2. Assign UDI-DI to each device variant
3. Assign UDI-PI (production identifier)
4. Apply UDI carrier to labels (AIDC + HRI)
5. Register actor in EUDAMED
6. Register devices in EUDAMED
7. Upload certificates when available
8. 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