# Send Mdr 745 Specialist to your agent Hand the extracted package to your coding agent with a concrete install brief instead of figuring it out manually. ## Fast path - Download the package from Yavira. - Extract it into a folder your agent can access. - Paste one of the prompts below and point your agent at the extracted folder. ## Suggested prompts ### New install ```text I downloaded a skill package from Yavira. Read SKILL.md from the extracted folder and install it by following the included instructions. Tell me what you changed and call out any manual steps you could not complete. ``` ### Upgrade existing ```text I downloaded an updated skill package from Yavira. Read SKILL.md from the extracted folder, compare it with my current installation, and upgrade it while preserving any custom configuration unless the package docs explicitly say otherwise. Summarize what changed and any follow-up checks I should run. ``` ## Machine-readable fields ```json { "schemaVersion": "1.0", "item": { "slug": "mdr-745-specialist", "name": "Mdr 745 Specialist", "source": "tencent", "type": "skill", "category": "开发工具", "sourceUrl": "https://clawhub.ai/alirezarezvani/mdr-745-specialist", "canonicalUrl": "https://clawhub.ai/alirezarezvani/mdr-745-specialist", "targetPlatform": "OpenClaw" }, "install": { "downloadUrl": "/downloads/mdr-745-specialist", "sourceDownloadUrl": "https://wry-manatee-359.convex.site/api/v1/download?slug=mdr-745-specialist", "sourcePlatform": "tencent", "targetPlatform": "OpenClaw", "packageFormat": "ZIP package", "primaryDoc": "SKILL.md", "includedAssets": [ "SKILL.md", "references/clinical-evidence-requirements.md", "references/mdr-classification-guide.md", "references/technical-documentation-templates.md", "scripts/mdr_gap_analyzer.py" ], "downloadMode": "redirect", "sourceHealth": { "source": "tencent", "status": "healthy", "reason": "direct_download_ok", "recommendedAction": "download", "checkedAt": "2026-04-30T16:55:25.780Z", "expiresAt": "2026-05-07T16:55:25.780Z", "httpStatus": 200, "finalUrl": "https://wry-manatee-359.convex.site/api/v1/download?slug=network", "contentType": "application/zip", "probeMethod": "head", "details": { "probeUrl": "https://wry-manatee-359.convex.site/api/v1/download?slug=network", "contentDisposition": "attachment; filename=\"network-1.0.0.zip\"", "redirectLocation": null, "bodySnippet": null }, "scope": "source", "summary": "Source download looks usable.", "detail": "Yavira can redirect you to the upstream package for this source.", "primaryActionLabel": "Download for OpenClaw", "primaryActionHref": "/downloads/mdr-745-specialist" }, "validation": { "installChecklist": [ "Use the Yavira download entry.", "Review SKILL.md after the package is downloaded.", "Confirm the extracted package contains the expected setup assets." ], "postInstallChecks": [ "Confirm the extracted package includes the expected docs or setup files.", "Validate the skill or prompts are available in your target agent workspace.", "Capture any manual follow-up steps the agent could not complete." ] } }, "links": { "detailUrl": "https://openagent3.xyz/skills/mdr-745-specialist", "downloadUrl": "https://openagent3.xyz/downloads/mdr-745-specialist", "agentUrl": "https://openagent3.xyz/skills/mdr-745-specialist/agent", "manifestUrl": "https://openagent3.xyz/skills/mdr-745-specialist/agent.json", "briefUrl": "https://openagent3.xyz/skills/mdr-745-specialist/agent.md" } } ``` ## Documentation ### 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: 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 ## Trust - Source: tencent - Verification: Indexed source record - Publisher: alirezarezvani - Version: 2.1.1 ## Source health - Status: healthy - Source download looks usable. - Yavira can redirect you to the upstream package for this source. - Health scope: source - Reason: direct_download_ok - Checked at: 2026-04-30T16:55:25.780Z - Expires at: 2026-05-07T16:55:25.780Z - Recommended action: Download for OpenClaw ## Links - [Detail page](https://openagent3.xyz/skills/mdr-745-specialist) - [Send to Agent page](https://openagent3.xyz/skills/mdr-745-specialist/agent) - [JSON manifest](https://openagent3.xyz/skills/mdr-745-specialist/agent.json) - [Markdown brief](https://openagent3.xyz/skills/mdr-745-specialist/agent.md) - [Download page](https://openagent3.xyz/downloads/mdr-745-specialist)