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Mdr 745 Specialist

Name: Mdr 745 Specialist
Rating: 4.2 (5 reviews)
Author: Alireza Rezvani

by Alireza Rezvani alirezarezvani/mdr-745-specialist multi-file Updated Jul 6, 2026

Classify medical devices under EU MDR 2017/745, build technical documentation, plan clinical evaluations, and manage post-market surveillance and EUDAMED integration.

SKILL.md

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, or Annex X + XI	QMS + tech doc assessment, or type exam + production
III	Annex IX, or Annex X + XI	Full QMS + product dossier, or type exam + production

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	Article 86 — Class IIa and higher	Per Art. 86(1) schedule below
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 (MDR Art. 86(1))
Class III	Updated at least annually
Class IIb (all, incl. implantable)	Updated at least annually
Class IIa	When necessary, at least every 2 years
Class I	No PSUR — PMS report instead (Art. 85)

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

---
name: mdr-745-specialist
description: Classify medical devices under EU MDR 2017/745, build technical documentation, plan clinical evaluations, and manage post-market surveillance and EUDAMED integration.
---

# MDR 2017/745 Specialist

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

---

## Table of Contents

- [Device Classification Workflow](#device-classification-workflow)
- [Technical Documentation](#technical-documentation)
- [Clinical Evidence](#clinical-evidence)
- [Post-Market Surveillance](#post-market-surveillance)
- [EUDAMED and UDI](#eudamed-and-udi)
- [Reference Documentation](#reference-documentation)
- [Tools](#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, or Annex X + XI | QMS + tech doc assessment, or type exam + production |
| III | Annex IX, or Annex X + XI | Full QMS + product dossier, or type exam + production |

---

## 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 | Article 86 — Class IIa and higher | Per Art. 86(1) schedule below |
| 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 (MDR Art. 86(1)) |
|-------|-----------------------------|
| Class III | Updated at least annually |
| Class IIb (all, incl. implantable) | Updated at least annually |
| Class IIa | When necessary, at least every 2 years |
| Class I | No PSUR — PMS report instead (Art. 85) |

### 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

```bash
# 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

alirezarezvani/claude-skills/tree/main/ra-qm-team/skills/mdr-745-specialist commit · 2fb75e1af3

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Classifies medical devices under EU MDR 2017/745 Annex VIII rules, including software per MDCG 2019-11, with examples and conformity assessment routes.

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Frequently asked questions

How do I install the Mdr 745 Specialist skill?

Run npx skillmds add alirezarezvani/mdr-745-specialist in your terminal (requires Node.js), paste this page's agent-chat prompt into Claude, Cursor, or any MCP-connected agent, or download the SKILL.md file and copy it into your agent's skills directory.

What does the Mdr 745 Specialist skill do?

Classify medical devices under EU MDR 2017/745, build technical documentation, plan clinical evaluations, and manage post-market surveillance and EUDAMED integration. It is listed under Docs & Writing, Research & Search, Security, Compliance & Privacy, Technical Writing on SkillMD.

Is Mdr 745 Specialist safe to use?

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Which AI agents work with Mdr 745 Specialist?

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Is Mdr 745 Specialist free to use?

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Who published Mdr 745 Specialist?

Alireza Rezvani (@alirezarezvani) published this skill. Their other Agent Skills are listed on their SkillMD profile.