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Mdr 745 Specialist

EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance. Covers Annex VIII classification rules, Annex II/III technical files, Annex XIV clinical evaluation, and EUDAMED integration.

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Target platform: OpenClaw
Install method: Manual import
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Prerequisites: OpenClaw
Primary doc: SKILL.md

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Download mode: Yavira redirect
Package format: ZIP package
Source platform: Tencent SkillHub
What's included: SKILL.md, references/clinical-evidence-requirements.md, references/mdr-classification-guide.md, references/technical-documentation-templates.md, scripts/mdr_gap_analyzer.py

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Release facts

Source: Tencent SkillHub
Verification: Indexed source record
Version: 2.1.1

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Publisher: alirezarezvani
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Documentation

ClawHub primary doc Primary doc: SKILL.md 27 sections Open source page

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

FactorClass IClass IIaClass IIbClass IIIDurationAnyShort-termLong-termLong-termInvasivenessNon-invasiveBody orificeSurgicalImplantableSystemAnyNon-criticalCritical organsCNS/cardiacRiskLowestLow-mediumMedium-highHighest

Software Classification (MDCG 2019-11)

Information UseCondition SeverityClassInforms decisionNon-seriousIIaInforms decisionSeriousIIbDrives/treatsCriticalIII

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

RequirementEvidenceStatusSafe 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

ClassRouteNB InvolvementIAnnex II self-declarationNoneIs/ImAnnex II + IX/XISterile/measuring aspectsIIaAnnex II + IX or XIProduct or QMSIIbAnnex IX + X or X + XIType exam + productionIIIAnnex IX + XFull 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

ClassMinimum EvidenceInvestigationIRisk-benefit analysisNot typically requiredIIaLiterature + post-marketMay be requiredIIbSystematic literature reviewOften requiredIIIComprehensive clinical dataRequired (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

ComponentRequirementFrequencyPMS PlanArticle 84Maintain currentPSURClass IIa and higherPer class schedulePMCF PlanAnnex XIV Part BUpdate with CERPMCF ReportAnnex XIV Part BAnnual (Class III)VigilanceArticles 87-92As events occur

PSUR Schedule

ClassFrequencyClass IIIAnnualClass IIb implantableAnnualClass IIbEvery 2 yearsClass IIaWhen necessary

Serious Incident Reporting

TimelineRequirement2 daysSerious public health threat10 daysDeath or serious deterioration15 daysOther 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

ModuleContentActorActorCompany registrationManufacturer, ARUDI/DeviceDevice and variant dataManufacturerCertificatesNB certificatesNotified BodyClinical InvestigationStudy registrationSponsorVigilanceIncident reportsManufacturerMarket SurveillanceAuthority actionsCompetent 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)

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

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

Selection Criteria

FactorConsiderationsDesignation scopeCovers your device typeCapacityTimeline for initial auditGeographic reachMarkets you need to accessTechnical expertiseExperience with your technologyFee structureTransparency, 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

Category context

Code helpers, APIs, CLIs, browser automation, testing, and developer operations.

Source: Tencent SkillHub

Largest current source with strong distribution and engagement signals.

Package contents

Included in package

4 Docs1 Scripts

SKILL.md Primary doc
references/clinical-evidence-requirements.md Docs
references/mdr-classification-guide.md Docs
references/technical-documentation-templates.md Docs
scripts/mdr_gap_analyzer.py Scripts