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    "sections": [
      {
        "title": "MDR 2017/745 Specialist",
        "body": "EU MDR compliance patterns for medical device classification, technical documentation, and clinical evidence."
      },
      {
        "title": "Table of Contents",
        "body": "Device Classification Workflow\nTechnical Documentation\nClinical Evidence\nPost-Market Surveillance\nEUDAMED and UDI\nReference Documentation\nTools"
      },
      {
        "title": "Device Classification Workflow",
        "body": "Classify device under MDR Annex VIII:\n\nIdentify device duration (transient, short-term, long-term)\nDetermine invasiveness level (non-invasive, body orifice, surgical)\nAssess body system contact (CNS, cardiac, other)\nCheck if active device (energy dependent)\nApply classification rules 1-22\nFor software, apply MDCG 2019-11 algorithm\nDocument classification rationale\nValidation: Classification confirmed with Notified Body"
      },
      {
        "title": "Classification Matrix",
        "body": "FactorClass IClass IIaClass IIbClass IIIDurationAnyShort-termLong-termLong-termInvasivenessNon-invasiveBody orificeSurgicalImplantableSystemAnyNon-criticalCritical organsCNS/cardiacRiskLowestLow-mediumMedium-highHighest"
      },
      {
        "title": "Software Classification (MDCG 2019-11)",
        "body": "Information UseCondition SeverityClassInforms decisionNon-seriousIIaInforms decisionSeriousIIbDrives/treatsCriticalIII"
      },
      {
        "title": "Classification Examples",
        "body": "Example 1: Absorbable Surgical Suture\n\nRule 8 (implantable, long-term)\nDuration: > 30 days (absorbed)\nContact: General tissue\nClassification: Class IIb\n\nExample 2: AI Diagnostic Software\n\nRule 11 + MDCG 2019-11\nFunction: Diagnoses serious condition\nClassification: Class IIb\n\nExample 3: Cardiac Pacemaker\n\nRule 8 (implantable)\nContact: Central circulatory system\nClassification: Class III"
      },
      {
        "title": "Technical Documentation",
        "body": "Prepare technical file per Annex II and III:\n\nCreate device description (variants, accessories, intended purpose)\nDevelop labeling (Article 13 requirements, IFU)\nDocument design and manufacturing process\nComplete GSPR compliance matrix\nPrepare benefit-risk analysis\nCompile verification and validation evidence\nIntegrate risk management file (ISO 14971)\nValidation: Technical file reviewed for completeness"
      },
      {
        "title": "Technical File Structure",
        "body": "ANNEX II TECHNICAL DOCUMENTATION\n├── Device description and UDI-DI\n├── Label and instructions for use\n├── Design and manufacturing info\n├── GSPR compliance matrix\n├── Benefit-risk analysis\n├── Verification and validation\n└── Clinical evaluation report"
      },
      {
        "title": "GSPR Compliance Checklist",
        "body": "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☐"
      },
      {
        "title": "Conformity Assessment Routes",
        "body": "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"
      },
      {
        "title": "Clinical Evidence",
        "body": "Develop clinical evidence strategy per Annex XIV:\n\nDefine clinical claims and endpoints\nConduct systematic literature search\nAppraise clinical data quality\nAssess equivalence (technical, biological, clinical)\nIdentify evidence gaps\nDetermine if clinical investigation required\nPrepare Clinical Evaluation Report (CER)\nValidation: CER reviewed by qualified evaluator"
      },
      {
        "title": "Evidence Requirements by Class",
        "body": "ClassMinimum EvidenceInvestigationIRisk-benefit analysisNot typically requiredIIaLiterature + post-marketMay be requiredIIbSystematic literature reviewOften requiredIIIComprehensive clinical dataRequired (Article 61)"
      },
      {
        "title": "Clinical Evaluation Report Structure",
        "body": "CER CONTENTS\n├── Executive summary\n├── Device scope and intended purpose\n├── Clinical background (state of the art)\n├── Literature search methodology\n├── Data appraisal and analysis\n├── Safety and performance conclusions\n├── Benefit-risk determination\n└── PMCF plan summary"
      },
      {
        "title": "Qualified Evaluator Requirements",
        "body": "Medical degree or equivalent healthcare qualification\n4+ years clinical experience in relevant field\nTraining in clinical evaluation methodology\nUnderstanding of MDR requirements"
      },
      {
        "title": "Post-Market Surveillance",
        "body": "Establish PMS system per Chapter VII:\n\nDevelop PMS plan (Article 84)\nDefine data collection methods\nEstablish complaint handling procedures\nCreate vigilance reporting process\nPlan Periodic Safety Update Reports (PSUR)\nIntegrate with PMCF activities\nDefine trend analysis and signal detection\nValidation: PMS system audited annually"
      },
      {
        "title": "PMS System Components",
        "body": "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"
      },
      {
        "title": "PSUR Schedule",
        "body": "ClassFrequencyClass IIIAnnualClass IIb implantableAnnualClass IIbEvery 2 yearsClass IIaWhen necessary"
      },
      {
        "title": "Serious Incident Reporting",
        "body": "TimelineRequirement2 daysSerious public health threat10 daysDeath or serious deterioration15 daysOther serious incidents"
      },
      {
        "title": "EUDAMED and UDI",
        "body": "Implement UDI system per Article 27:\n\nObtain issuing entity code (GS1, HIBCC, ICCBBA)\nAssign UDI-DI to each device variant\nAssign UDI-PI (production identifier)\nApply UDI carrier to labels (AIDC + HRI)\nRegister actor in EUDAMED\nRegister devices in EUDAMED\nUpload certificates when available\nValidation: UDI verified on sample labels"
      },
      {
        "title": "EUDAMED Modules",
        "body": "ModuleContentActorActorCompany registrationManufacturer, ARUDI/DeviceDevice and variant dataManufacturerCertificatesNB certificatesNotified BodyClinical InvestigationStudy registrationSponsorVigilanceIncident reportsManufacturerMarket SurveillanceAuthority actionsCompetent Authority"
      },
      {
        "title": "UDI Label Requirements",
        "body": "Required elements per Article 13:\n\nUDI-DI (device identifier)\n UDI-PI (production identifier) for Class II+\n AIDC format (barcode/RFID)\n HRI format (human-readable)\n Manufacturer name and address\n Lot/serial number\n Expiration date (if applicable)"
      },
      {
        "title": "MDR Classification Guide",
        "body": "references/mdr-classification-guide.md contains:\n\nComplete Annex VIII classification rules (Rules 1-22)\nSoftware classification per MDCG 2019-11\nWorked classification examples\nConformity assessment route selection"
      },
      {
        "title": "Clinical Evidence Requirements",
        "body": "references/clinical-evidence-requirements.md contains:\n\nClinical evidence framework and hierarchy\nLiterature search methodology\nClinical Evaluation Report structure\nPMCF plan and evaluation report guidance"
      },
      {
        "title": "Technical Documentation Templates",
        "body": "references/technical-documentation-templates.md contains:\n\nAnnex II and III content requirements\nDesign History File structure\nGSPR compliance matrix template\nDeclaration of Conformity template\nNotified Body submission checklist"
      },
      {
        "title": "MDR Gap Analyzer",
        "body": "# Quick gap analysis\npython scripts/mdr_gap_analyzer.py --device \"Device Name\" --class IIa\n\n# JSON output for integration\npython scripts/mdr_gap_analyzer.py --device \"Device Name\" --class III --output json\n\n# Interactive assessment\npython scripts/mdr_gap_analyzer.py --interactive\n\nAnalyzes device against MDR requirements, identifies compliance gaps, generates prioritized recommendations.\n\nOutput includes:\n\nRequirements checklist by category\nGap identification with priorities\nCritical gap highlighting\nCompliance roadmap recommendations"
      },
      {
        "title": "Selection Criteria",
        "body": "FactorConsiderationsDesignation scopeCovers your device typeCapacityTimeline for initial auditGeographic reachMarkets you need to accessTechnical expertiseExperience with your technologyFee structureTransparency, predictability"
      },
      {
        "title": "Pre-Submission Checklist",
        "body": "Technical documentation complete\n GSPR matrix fully addressed\n Risk management file current\n Clinical evaluation report complete\n QMS (ISO 13485) certified\n Labeling and IFU finalized\n Validation: Internal gap assessment complete"
      }
    ],
    "body": "MDR 2017/745 Specialist\n\nEU MDR compliance patterns for medical device classification, technical documentation, and clinical evidence.\n\nTable of Contents\nDevice Classification Workflow\nTechnical Documentation\nClinical Evidence\nPost-Market Surveillance\nEUDAMED and UDI\nReference Documentation\nTools\nDevice Classification Workflow\n\nClassify device under MDR Annex VIII:\n\nIdentify device duration (transient, short-term, long-term)\nDetermine invasiveness level (non-invasive, body orifice, surgical)\nAssess body system contact (CNS, cardiac, other)\nCheck if active device (energy dependent)\nApply classification rules 1-22\nFor software, apply MDCG 2019-11 algorithm\nDocument classification rationale\nValidation: Classification confirmed with Notified Body\nClassification Matrix\nFactor\tClass I\tClass IIa\tClass IIb\tClass III\nDuration\tAny\tShort-term\tLong-term\tLong-term\nInvasiveness\tNon-invasive\tBody orifice\tSurgical\tImplantable\nSystem\tAny\tNon-critical\tCritical organs\tCNS/cardiac\nRisk\tLowest\tLow-medium\tMedium-high\tHighest\nSoftware Classification (MDCG 2019-11)\nInformation Use\tCondition Severity\tClass\nInforms decision\tNon-serious\tIIa\nInforms decision\tSerious\tIIb\nDrives/treats\tCritical\tIII\nClassification Examples\n\nExample 1: Absorbable Surgical Suture\n\nRule 8 (implantable, long-term)\nDuration: > 30 days (absorbed)\nContact: General tissue\nClassification: Class IIb\n\nExample 2: AI Diagnostic Software\n\nRule 11 + MDCG 2019-11\nFunction: Diagnoses serious condition\nClassification: Class IIb\n\nExample 3: Cardiac Pacemaker\n\nRule 8 (implantable)\nContact: Central circulatory system\nClassification: Class III\nTechnical Documentation\n\nPrepare technical file per Annex II and III:\n\nCreate device description (variants, accessories, intended purpose)\nDevelop labeling (Article 13 requirements, IFU)\nDocument design and manufacturing process\nComplete GSPR compliance matrix\nPrepare benefit-risk analysis\nCompile verification and validation evidence\nIntegrate risk management file (ISO 14971)\nValidation: Technical file reviewed for completeness\nTechnical File Structure\nANNEX II TECHNICAL DOCUMENTATION\n├── Device description and UDI-DI\n├── Label and instructions for use\n├── Design and manufacturing info\n├── GSPR compliance matrix\n├── Benefit-risk analysis\n├── Verification and validation\n└── Clinical evaluation report\n\nGSPR Compliance Checklist\nRequirement\tEvidence\tStatus\nSafe design (GSPR 1-3)\tRisk management file\t☐\nChemical properties (GSPR 10.1)\tBiocompatibility report\t☐\nInfection risk (GSPR 10.2)\tSterilization validation\t☐\nSoftware requirements (GSPR 17)\tIEC 62304 documentation\t☐\nLabeling (GSPR 23)\tLabel artwork, IFU\t☐\nConformity Assessment Routes\nClass\tRoute\tNB Involvement\nI\tAnnex II self-declaration\tNone\nIs/Im\tAnnex II + IX/XI\tSterile/measuring aspects\nIIa\tAnnex II + IX or XI\tProduct or QMS\nIIb\tAnnex IX + X or X + XI\tType exam + production\nIII\tAnnex IX + X\tFull QMS + type exam\nClinical Evidence\n\nDevelop clinical evidence strategy per Annex XIV:\n\nDefine clinical claims and endpoints\nConduct systematic literature search\nAppraise clinical data quality\nAssess equivalence (technical, biological, clinical)\nIdentify evidence gaps\nDetermine if clinical investigation required\nPrepare Clinical Evaluation Report (CER)\nValidation: CER reviewed by qualified evaluator\nEvidence Requirements by Class\nClass\tMinimum Evidence\tInvestigation\nI\tRisk-benefit analysis\tNot typically required\nIIa\tLiterature + post-market\tMay be required\nIIb\tSystematic literature review\tOften required\nIII\tComprehensive clinical data\tRequired (Article 61)\nClinical Evaluation Report Structure\nCER CONTENTS\n├── Executive summary\n├── Device scope and intended purpose\n├── Clinical background (state of the art)\n├── Literature search methodology\n├── Data appraisal and analysis\n├── Safety and performance conclusions\n├── Benefit-risk determination\n└── PMCF plan summary\n\nQualified Evaluator Requirements\nMedical degree or equivalent healthcare qualification\n4+ years clinical experience in relevant field\nTraining in clinical evaluation methodology\nUnderstanding of MDR requirements\nPost-Market Surveillance\n\nEstablish PMS system per Chapter VII:\n\nDevelop PMS plan (Article 84)\nDefine data collection methods\nEstablish complaint handling procedures\nCreate vigilance reporting process\nPlan Periodic Safety Update Reports (PSUR)\nIntegrate with PMCF activities\nDefine trend analysis and signal detection\nValidation: PMS system audited annually\nPMS System Components\nComponent\tRequirement\tFrequency\nPMS Plan\tArticle 84\tMaintain current\nPSUR\tClass IIa and higher\tPer class schedule\nPMCF Plan\tAnnex XIV Part B\tUpdate with CER\nPMCF Report\tAnnex XIV Part B\tAnnual (Class III)\nVigilance\tArticles 87-92\tAs events occur\nPSUR Schedule\nClass\tFrequency\nClass III\tAnnual\nClass IIb implantable\tAnnual\nClass IIb\tEvery 2 years\nClass IIa\tWhen necessary\nSerious Incident Reporting\nTimeline\tRequirement\n2 days\tSerious public health threat\n10 days\tDeath or serious deterioration\n15 days\tOther serious incidents\nEUDAMED and UDI\n\nImplement UDI system per Article 27:\n\nObtain issuing entity code (GS1, HIBCC, ICCBBA)\nAssign UDI-DI to each device variant\nAssign UDI-PI (production identifier)\nApply UDI carrier to labels (AIDC + HRI)\nRegister actor in EUDAMED\nRegister devices in EUDAMED\nUpload certificates when available\nValidation: UDI verified on sample labels\nEUDAMED Modules\nModule\tContent\tActor\nActor\tCompany registration\tManufacturer, AR\nUDI/Device\tDevice and variant data\tManufacturer\nCertificates\tNB certificates\tNotified Body\nClinical Investigation\tStudy registration\tSponsor\nVigilance\tIncident reports\tManufacturer\nMarket Surveillance\tAuthority actions\tCompetent Authority\nUDI Label Requirements\n\nRequired elements per Article 13:\n\n UDI-DI (device identifier)\n UDI-PI (production identifier) for Class II+\n AIDC format (barcode/RFID)\n HRI format (human-readable)\n Manufacturer name and address\n Lot/serial number\n Expiration date (if applicable)\nReference Documentation\nMDR Classification Guide\n\nreferences/mdr-classification-guide.md contains:\n\nComplete Annex VIII classification rules (Rules 1-22)\nSoftware classification per MDCG 2019-11\nWorked classification examples\nConformity assessment route selection\nClinical Evidence Requirements\n\nreferences/clinical-evidence-requirements.md contains:\n\nClinical evidence framework and hierarchy\nLiterature search methodology\nClinical Evaluation Report structure\nPMCF plan and evaluation report guidance\nTechnical Documentation Templates\n\nreferences/technical-documentation-templates.md contains:\n\nAnnex II and III content requirements\nDesign History File structure\nGSPR compliance matrix template\nDeclaration of Conformity template\nNotified Body submission checklist\nTools\nMDR Gap Analyzer\n# Quick gap analysis\npython scripts/mdr_gap_analyzer.py --device \"Device Name\" --class IIa\n\n# JSON output for integration\npython scripts/mdr_gap_analyzer.py --device \"Device Name\" --class III --output json\n\n# Interactive assessment\npython scripts/mdr_gap_analyzer.py --interactive\n\n\nAnalyzes device against MDR requirements, identifies compliance gaps, generates prioritized recommendations.\n\nOutput includes:\n\nRequirements checklist by category\nGap identification with priorities\nCritical gap highlighting\nCompliance roadmap recommendations\nNotified Body Interface\nSelection Criteria\nFactor\tConsiderations\nDesignation scope\tCovers your device type\nCapacity\tTimeline for initial audit\nGeographic reach\tMarkets you need to access\nTechnical expertise\tExperience with your technology\nFee structure\tTransparency, predictability\nPre-Submission Checklist\n Technical documentation complete\n GSPR matrix fully addressed\n Risk management file current\n Clinical evaluation report complete\n QMS (ISO 13485) certified\n Labeling and IFU finalized\n Validation: Internal gap assessment complete"
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