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Architecture
1. Introduction and Goals
2. Architecture Constraints
3. Context and Scope
4. Solution Strategy
5. Building Block View
6. Runtime View
7. Deployment View
8. Crosscutting Concepts
9. Architecture Decisions
10. Quality Requirements
11. Risks and Technical Debt
12. Glossary
The arrival bundle format
Decisions (ADRs)
Decisions (ADRs)
ADR-0001: Content-Addressed Document Storage with PostgreSQL as Source of Truth
ADR-0002: Single Instance with Scope Hierarchy and Copy-on-Derive
ADR-0003: Fixed Life Cycle States with Configurable Review Processes
ADR-0004: Global Catalogs for Roles and Document Types with Per-Scope Activation
ADR-0005: Modular Monolith
ADR-0006: Three-Layer Search with In-Database Index and Pluggable LLM
ADR-0007: Angular Frontend with Server-Side-Only Enforcement
ADR-0008: Flyway Migrations and jOOQ Codegen from the Migrated Schema
ADR-0009: RLS Enforcement via a Session-Scoped Authorized Scope Set
ADR-0010: Self-Managed QMS via an Internal Mandator
ADR-0011: Authentication via OIDC SSO with Server-Side (BFF) Sessions
ADR-0012: Permission-Based Authorization and System Bootstrap
ADR-0013: User Identity Lifecycle
ADR-0014: Electronic Signatures (Part 11 / Annex 11-Capable)
ADR-0015: Document Effectivity, Periodic Review & Validity
ADR-0016: Data Retention, Disposal & Privacy (FADP / GDPR)
ADR-0017: Multi-Part Version Content
ADR-0018: Non-Functional Targets (Capacity, Availability, Security)
ADR-0019: Notifications & Tasks
ADR-0020: Internationalization (Content Language, Time Zones, Formatting)
ADR-0021: General Typed Document Relationships
ADR-0022: Read-Acknowledgement & Questionnaires
ADR-0023: Migration / Import — Current Released State
ADR-0024: Draft / In-Review Cancellation
ADR-0025: Disposal & Erasure Mechanics (Storage, Index, Backups)
ADR-0026: RLS Runtime Safety — Connection-Pool Scope Isolation
ADR-0027: RLS Boundary — Content-Plane vs Control-Plane
ADR-0028: Stateless Encrypted Token-State Cookie (no server-side session store)
ADR-0029: Document Content Model — Draft-Freeze, Content-Table RLS, Append-Only Audit
ADR-0030: Review & Life-Cycle Realization Model
ADR-0031: Released-base readability enforcement & copy-on-derive mechanics
ADR-0032: Frontend realization — Quinoa, Angular Material, i18n & E2E
ADR-0033: CSRF control for the BFF session — SameSite + JSON content-type
ADR-0034: Notification realization — in-process domain events + system-context fan-out
ADR-0035: Fan-out contract as shipped — gate semantics, count disclosure, audit protocol
ADR-0036: Repository layer — services carry rules, repositories carry jOOQ
ADR-0037: Task scheduler — in-process tick, advisory-lock election, SQL sweep
ADR-0038: Periodic-review realization — derived due date, policy-gated confirmation
ADR-0039: Sweep & periodic-review contract as shipped — grants, guards, addressing
ADR-0040: Disposal-due surfacing — closure-anchored retention, scope-level legal hold
ADR-0041: Email channel & notification i18n — notification-as-outbox, structured messages
ADR-0042: Disposal execution — document tombstoning, single-actor hard-gated destruction
ADR-0043: Disposal blob deletion is post-commit, GC-backstopped
ADR-0044: Search FTS baseline — event-indexed, RLS-scoped search_index
ADR-0045: Image Attachments as Content Parts (Rich-Content Slice R2)
ADR-0046: Four-Eyes — Submitter Excluded from Approval
ADR-0047: Four-Eyes — Submitter-Only Exclusion
ADR-0048: Document Organization — Folder Tree per Scope
ADR-0049: Content Model Round 2 — Type Categories, Template Instantiation, Trace Relations, Completeness Rules
ADR-0050: Live Frontend — SSE State Push, CodeMirror 6, Draft Presence
ADR-0051: In-Text Document Links (doc: Scheme)
ADR-0052: Addressees & Read-Acknowledgement (REQ-TRN Realization)
ADR-0053: Addressees Per Document + Process Owner (amends ADR-0052 K-1)
ADR-0054: Process Owner Is a Role (amends ADR-0053 P-3)
ADR-0055: WYSIWYG Editing Mode over Markdown (editor step R4)
ADR-0056: Visual-Editor Chrome via Milkdown Crepe (gated adoption)
ADR-0057: Content Record Is the ProseMirror Document Tree; Markdown Becomes a Derived Projection
ADR-0058: PM_DOC Is the Only Content Format (pre-production cut; amends ADR-0057 §5)
ADR-0059: Editor Engine Switches to TipTap (spike-gated; supersedes the Milkdown/Crepe choice)
ADR-0060: Backup & Restore — Scripted Ordered Backup with Automated Restore Rehearsal
ADR-0061: CSV — Generated Validation Package per Release
ADR-0062: SBOM — CycloneDX over the Production Layers, Validated Against the Artifact
ADR-0063: User Identity Binds on Subject Only (Issuer Becomes Provenance)
ADR-0064: Per-Document Workflow Role Bindings (Author / Reviewer / Releaser), Enforced
ADR-0065: Diagrams — Excalidraw as the Manual Layer, Mermaid Stays for Text-First/UML
ADR-0066: WITHDRAW — the Author Side May Reclaim a Version from Review
ADR-0067: Review Comments — Anchored, Immutable, Resolvable
ADR-0068: Confluence/Jira QMS Import — Staged, Read-Only, Repeatable
ADR-0069: Arbitrary File Attachments — Download-Only Confinement
ADR-0070: Training Questionnaires — Versioned, Auto-Scored, Release-Gated
ADR-0071: Training Plans — Document Obligations + External Trainings & Certifications
ADR-0072: Diagrams — Self-Hosted draw.io Replaces Excalidraw
ADR-0073: Per-Scope QMS Configuration Surface
ADR-0074: PDF Export of Released Documents — Server-Side via Apache FOP over the Canonical Projection
ADR-0075: Source History Import — Continuity Without Forged Audit
ADR-0076: Periodic-review status visibility (completing MVP gap #2)
ADR-0077: Requirement Items — Keyed Blocks Inside Controlled Documents
ADR-0078: Generalized Trace Items (Traceability Model — Stage A)
ADR-0079: Risk & Risk-Control Items (Traceability Model — Stage B)
ADR-0080: Traceability Workspace — Hub, Sub-Pages, and Role-Gated Views
ADR-0081: Draft-Only Trace-Structure Changes, Server-Enforced
ADR-0082: Table-Shaped Risk Authoring over Risk Blocks
ADR-0083: The TD Dossier — a Versioned, Cross-Scope, Regulatory-Structured Deliverable
ADR-0084: Validation & Regulatory Axes (Traceability Model — Stage C)
ADR-0085: Relation-Layer Consolidation — One Trace Vocabulary, One Surface
ADR-0086: Requirement Traceability Chains — End-to-End Path View + Flat Path Export
ADR-0087: The Scope Traceability Report — One Derived Overview Artifact, Never a Controlled Document
ADR-0088: Verification Evidence Classes — Planned vs. Verified, Derived at the Read Layer
ADR-0089: Recurring Obligations — Periodic Tasks With Record Evidence, Not Calendar Series
ADR-0090: Release & Versioning Policy — Deliberate Releases, One Auditor-Facing Number
ADR-0091: Release Modes — Single-Person Record Release With a Structural Four-Eyes Floor
ADR-0092: Orphan-Blob Garbage Collection With a Quarantine Bin
ADR-0093: One Scope Context — the Toolbar Switcher Is the Only Scope Selector
ADR-0094: Calendar-Anchored Obligation Schedules (Clamped, Never Too Late)
ADR-0095: Key-Rule Governance — Free Until First Use, Then Frozen
ADR-0096: Transition Permissions — Always Visible, Deny Unless Granted
ADR-0097: A Governed Provisioning Surface — MANAGE_SCOPES
ADR-0098: Org Chart × Role System — Marriage at the Evidence Level, Never in Authorization
ADR-0099: The User Manual is an In-App Topic Reference, Not a Document
ADR-0100: LQMS Is the Living Quality Management System
ADR-0101: The Executable Validation Journey (PQ Evidence That Cannot Drift)
ADR-0102: Typed Template Variables (text | date | number — and Deliberately No Enum)
ADR-0103: npm audit Joins the Verification Gate as a Second Standing Input
ADR-0104: The Issued Dossier Is a Persisted Artifact of Record — and Clones to a New Draft
ADR-0105: Navigation Information Architecture — Group by Moment-of-Use
ADR-0106: The Client Reflection Follows Assignments, Not Only Content Reach
ADR-0107: The Audit Append Gate Follows Assignment Reach, Not Content Reach
ADR-0108: Mandator Membership — Invite-Accept, with Pre-Assigned Responsibilities
ADR-0109: Organization Founding Is Its Own Process
ADR-0110: The Audit Trail Is Not a Read Model
ADR-0111: The Imported-Person Model, and Project Portability's First Doctrines
ADR-0112: The Element-Kind Catalog — Semantics in the Model, Not Only in the Code
ADR-0113: Project Arrival Import — Records Arrive as They Are, People Arrive as They Were
ADR-0114: The Operating Model Arrives — Roles as Functions, Names as Words, People as This Instance's Decision
ADR-0115: Collaborative Draft Editing — Two Carets, One Truth, Honest Credit
ADR-0116: The System Maintenance Surface — the App Backs Itself Up, the Host Keeps One Dumb Job
ADR-0117: Role Documentation — a Link, a Finding, Per-Source Recognizers; Substitution Rejected
ADR-0118: The Offline QMS Copy — the Repo Carries the Audit Pack, Not a Second Renderer
ADR-0119: Module-Internal Package Structure — Capabilities First, Layers Second, the Root Is the Surface
ADR-0120: The Shared Kernel — the Domain-Exception Vocabulary Leaves the Authorization Module
ADR-0121: The Project Administrator Role — Per-Scope Administration With Read Access, Seeded in the Base Catalog
ADR-0122: Organization-Level Administration — the Cascade Stays, Becomes Visible, and Founds Projects
ADR-0123: Draft Save-Points — Every Save Restorable, Kept for the Life of the Version
ADR-0124: The Birth Path Completes Without Borrowing Content Clothes
ADR-0125: The Export Twin — Export Emits an Arrival Bundle
ADR-0126: Project Dissolution — the Un-Birth of an Unused Scope
ADR-0127: The Base-QMS Layers — One Library, Derived Adaptations, Local Records
ADR-0128: The GLOBAL Cascade Carries Administration, Never Content
ADR-0129: Role Identity from a GLOBAL Assignment Acts in GLOBAL Alone
ADR-0130: Break-Glass — the Project Administrator's Escalation Is a First-Class, Witnessed, Self-Expiring Act
ADR-0131: Role Substitution as Declared Adoption Edges — Emergency Cover Is Governed, Own-Name, Timed Staffing
ADR-0132: Dual-Hat Reviewer Satisfaction Is a Declared Policy Choice — the Strict Floor Stays the Default
ADR-NNNN:
</span> </a> </li> </ul> </nav> </li> <li class="md-nav__item md-nav__item--nested"> <input class="md-nav__toggle md-toggle " type="checkbox" id="__nav_5" > <div class="md-nav__link md-nav__container"> <a href="../../requirements/" class="md-nav__link "> <span class="md-ellipsis"> Requirements </span> </a> <label class="md-nav__link " for="__nav_5" id="__nav_5_label" tabindex="0"> <span class="md-nav__icon md-icon"></span> </label> </div> <nav class="md-nav" data-md-level="1" aria-labelledby="__nav_5_label" aria-expanded="false"> <label class="md-nav__title" for="__nav_5"> <span class="md-nav__icon md-icon"></span> Requirements </label> <ul class="md-nav__list" data-md-scrollfix> <li class="md-nav__item"> <a href="../../requirements/stakeholder_requirements/" class="md-nav__link"> <span class="md-ellipsis"> Stakeholder Requirements </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/gap-analysis/" class="md-nav__link"> <span class="md-ellipsis"> Requirements Gap Analysis </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_admin/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Administration, Permissions & Onboarding </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_api_ui/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: API & User Interface </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_audit_reporting/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Audit Trail & Regulatory Reporting </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_auth/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Authentication & Session </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_backup/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Backup & Restore </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_catalogs/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Catalogs, Roles & Users </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_data_protection/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Data Protection, Retention & Disposal </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_documents/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Documents, Versions & Storage </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_dossiers/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Technical Documentation Dossiers </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_effectivity/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Effectivity, Periodic Review & Validity </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_gspr/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Regulatory Conformity (GSPR / Essential Principles) </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_i18n/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Internationalization </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_lifecycle/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Life Cycle & Reviews </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_memberships/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Mandator Membership & Invitations </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_migration/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Migration & Import </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_nfr/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Non-Functional </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_notifications/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Notifications & Tasks </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_obligations/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Recurring Obligations </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_relationships/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Document Relationships </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_risk/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Risk Management (ISO 14971 Hazards & Controls) </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_sbom/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Software Bill of Materials & Supply-Chain Assurance </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_search/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Search </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_separation/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Scopes, Mandators & Separation </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_signatures/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Electronic Signatures </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_training/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Read-Acknowledgement & Questionnaires </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_users/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: User Identity & Lifecycle </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_validation/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Design Validation & the Validation Traceability Axis </span> </a> </li> </ul> </nav> </li> <li class="md-nav__item md-nav__item--nested"> <input class="md-nav__toggle md-toggle " type="checkbox" id="__nav_6" > <div class="md-nav__link md-nav__container"> <a href="../../process/" class="md-nav__link "> <span class="md-ellipsis"> Process (IEC 62304) </span> </a> <label class="md-nav__link " for="__nav_6" id="__nav_6_label" tabindex="0"> <span class="md-nav__icon md-icon"></span> </label> </div> <nav class="md-nav" data-md-level="1" aria-labelledby="__nav_6_label" aria-expanded="false"> <label class="md-nav__title" for="__nav_6"> <span class="md-nav__icon md-icon"></span> Process (IEC 62304) </label> <ul class="md-nav__list" data-md-scrollfix> <li class="md-nav__item"> <a href="../../process/configuration_management_plan/" class="md-nav__link"> <span class="md-ellipsis"> Configuration Management Plan </span> </a> </li> <li class="md-nav__item"> <a href="../../process/problem_resolution/" class="md-nav__link"> <span class="md-ellipsis"> Problem Resolution Process </span> </a> </li> <li class="md-nav__item"> <a href="../../process/risk_management/" class="md-nav__link"> <span class="md-ellipsis"> Risk Management </span> </a> </li> <li class="md-nav__item"> <a href="../../process/software_development_plan/" class="md-nav__link"> <span class="md-ellipsis"> Software Development Plan </span> </a> </li> <li class="md-nav__item"> <a href="../../process/verification_plan/" class="md-nav__link"> <span class="md-ellipsis"> Verification Plan </span> </a> </li> </ul> </nav> </li> <li class="md-nav__item md-nav__item--nested"> <input class="md-nav__toggle md-toggle " type="checkbox" id="__nav_7" > <label class="md-nav__link" for="__nav_7" id="__nav_7_label" tabindex="0"> <span class="md-ellipsis"> Operations </span> <span class="md-nav__icon md-icon"></span> </label> <nav class="md-nav" data-md-level="1" aria-labelledby="__nav_7_label" aria-expanded="false"> <label class="md-nav__title" for="__nav_7"> <span class="md-nav__icon md-icon"></span> Operations </label> <ul class="md-nav__list" data-md-scrollfix> <li class="md-nav__item"> <a href="../../operations/genesis-installation/" class="md-nav__link"> <span class="md-ellipsis"> Genesis: Birthing an LQMS Installation with a Base Library </span> </a> </li> <li class="md-nav__item"> <a href="../../operations/deployment/" class="md-nav__link"> <span class="md-ellipsis"> LQMS Deployment Guide </span> </a> </li> <li class="md-nav__item"> <a href="../../operations/server-deployment/" class="md-nav__link"> <span class="md-ellipsis"> LQMS Server Deployment (single Linux host, public HTTPS) </span> </a> </li> </ul> </nav> </li> <li class="md-nav__item md-nav__item--nested"> <input class="md-nav__toggle md-toggle " type="checkbox" id="__nav_8" > <div class="md-nav__link md-nav__container"> <a href="../../traceability/" class="md-nav__link "> <span class="md-ellipsis"> Traceability </span> </a> <label class="md-nav__link " for="__nav_8" id="__nav_8_label" tabindex="0"> <span class="md-nav__icon md-icon"></span> </label> </div> <nav class="md-nav" data-md-level="1" aria-labelledby="__nav_8_label" aria-expanded="false"> <label class="md-nav__title" for="__nav_8"> <span class="md-nav__icon md-icon"></span> Traceability </label> <ul class="md-nav__list" data-md-scrollfix> <li class="md-nav__item"> <a href="../../traceability/matrix/" class="md-nav__link"> <span class="md-ellipsis"> Requirements Traceability Matrix </span> </a> </li> </ul> </nav> </li> <li class="md-nav__item md-nav__item--nested"> <input class="md-nav__toggle md-toggle " type="checkbox" id="__nav_9" > <div class="md-nav__link md-nav__container"> <a href="../../validation/" class="md-nav__link "> <span class="md-ellipsis"> Validation (tool lane) </span> </a> <label class="md-nav__link " for="__nav_9" id="__nav_9_label" tabindex="0"> <span class="md-nav__icon md-icon"></span> </label> </div> <nav class="md-nav" data-md-level="1" aria-labelledby="__nav_9_label" aria-expanded="false"> <label class="md-nav__title" for="__nav_9"> <span class="md-nav__icon md-icon"></span> Validation (tool lane) </label> <ul class="md-nav__list" data-md-scrollfix> <li class="md-nav__item"> <a href="../../validation/templates/ai-authorship-posture/" class="md-nav__link"> <span class="md-ellipsis"> AI-Authorship Posture — How LQMS Is Built, and Why the Validation Evidence Does Not Rest on It (TEMPLATE) </span> </a> </li> <li class="md-nav__item"> <a href="../../validation/templates/intended-use/" class="md-nav__link"> <span class="md-ellipsis"> Intended-Use Specification — LQMS as a QMS / Document-Control Tool (TEMPLATE) </span> </a> </li> <li class="md-nav__item"> <a href="../../validation/templates/tool-risk-assessment/" class="md-nav__link"> <span class="md-ellipsis"> Tool-Risk Assessment — LQMS as a QMS Tool (TEMPLATE) </span> </a> </li> </ul> </nav> </li> <li class="md-nav__item md-nav__item--active md-nav__item--nested"> <input class="md-nav__toggle md-toggle " type="checkbox" id="__nav_10" checked> <label class="md-nav__link" for="__nav_10" id="__nav_10_label" tabindex="0"> <span class="md-ellipsis"> Regulatory </span> <span class="md-nav__icon md-icon"></span> </label> <nav class="md-nav" data-md-level="1" aria-labelledby="__nav_10_label" aria-expanded="true"> <label class="md-nav__title" for="__nav_10"> <span class="md-nav__icon md-icon"></span> Regulatory </label> <ul class="md-nav__list" data-md-scrollfix> <li class="md-nav__item md-nav__item--active"> <input class="md-nav__toggle md-toggle" type="checkbox" id="__toc"> <label class="md-nav__link md-nav__link--active" for="__toc"> <span class="md-ellipsis"> MDR Annex I — GSPR authoring skeleton (paraphrased) </span> <span class="md-nav__icon md-icon"></span> </label> <a href="./" class="md-nav__link md-nav__link--active"> <span class="md-ellipsis"> MDR Annex I — GSPR authoring skeleton (paraphrased) </span> </a> <nav class="md-nav md-nav--secondary" aria-label="Table of contents"> <label class="md-nav__title" for="__toc"> <span class="md-nav__icon md-icon"></span> Table of contents </label> <ul class="md-nav__list" data-md-component="toc" data-md-scrollfix> <li class="md-nav__item"> <a href="#chapter-i--general-requirements-clauses-19" class="md-nav__link"> <span class="md-ellipsis"> Chapter I — General requirements (clauses 1–9) </span> </a> </li> <li class="md-nav__item"> <a href="#chapter-ii--requirements-regarding-design-and-manufacture-clauses-1022" class="md-nav__link"> <span class="md-ellipsis"> Chapter II — Requirements regarding design and manufacture (clauses 10–22) </span> </a> </li> <li class="md-nav__item"> <a href="#chapter-iii--information-supplied-with-the-device-clause-23" class="md-nav__link"> <span class="md-ellipsis"> Chapter III — Information supplied with the device (clause 23) </span> </a> </li> <li class="md-nav__item"> <a href="#notes" class="md-nav__link"> <span class="md-ellipsis"> Notes </span> </a> </li> </ul> </nav> </li> </ul> </nav> </li> <li class="md-nav__item md-nav__item--nested"> <input class="md-nav__toggle md-toggle " type="checkbox" id="__nav_11" > <div class="md-nav__link md-nav__container"> <a href="../../user-guide/" class="md-nav__link "> <span class="md-ellipsis"> User guide </span> </a> <label class="md-nav__link " for="__nav_11" id="__nav_11_label" tabindex="0"> <span class="md-nav__icon md-icon"></span> </label> </div> <nav class="md-nav" data-md-level="1" aria-labelledby="__nav_11_label" aria-expanded="false"> <label class="md-nav__title" for="__nav_11"> <span class="md-nav__icon md-icon"></span> User guide </label> <ul class="md-nav__list" data-md-scrollfix> <li class="md-nav__item"> <a href="../../user-guide/tutorial/" class="md-nav__link"> <span class="md-ellipsis"> Tutorial — from zero to a released document </span> </a> </li> <li class="md-nav__item"> <a href="../../user-guide/administration/" class="md-nav__link"> <span class="md-ellipsis"> Administering an LQMS Installation </span> </a> </li> <li class="md-nav__item"> <a href="../../user-guide/diagrams/" class="md-nav__link"> <span class="md-ellipsis"> Diagrams </span> </a> </li> <li class="md-nav__item"> <a href="../../user-guide/documents-lifecycle/" class="md-nav__link"> <span class="md-ellipsis"> Documents & the Lifecycle </span> </a> </li> <li class="md-nav__item"> <a href="../../user-guide/exports/" class="md-nav__link"> <span class="md-ellipsis"> PDF Exports & the Audit Pack </span> </a> </li> <li class="md-nav__item"> <a href="../../user-guide/obligations/" class="md-nav__link"> <span class="md-ellipsis"> Recurring Obligations </span> </a> </li> <li class="md-nav__item"> <a href="../../user-guide/project-context/" class="md-nav__link"> <span class="md-ellipsis"> The Project Context & App Version </span> </a> </li> <li 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invitations, acceptance, and what they change </span> </a> </li> <li class="md-nav__item"> <a href="../../user-guide/topics/provisioning-birth-path/" class="md-nav__link"> <span class="md-ellipsis"> How a new organization and project are born </span> </a> </li> <li class="md-nav__item"> <a href="../../user-guide/topics/review-policies/" class="md-nav__link"> <span class="md-ellipsis"> What a review policy controls, and what an empty grant means </span> </a> </li> <li class="md-nav__item"> <a href="../../user-guide/topics/setup-wizard-lanes/" class="md-nav__link"> <span class="md-ellipsis"> The setup wizard: the lanes, and what it writes </span> </a> </li> <li class="md-nav__item"> <a href="../../user-guide/topics/staffing-and-assignments/" class="md-nav__link"> <span class="md-ellipsis"> Staffing people into roles, and the accountable holder </span> </a> </li> <li class="md-nav__item"> <a href="../../user-guide/topics/technical-dossier/" class="md-nav__link"> <span class="md-ellipsis"> How do I assemble a technical dossier? </span> </a> </li> <li class="md-nav__item"> <a href="../../user-guide/trace-items/" class="md-nav__link"> <span class="md-ellipsis"> Trace Items — Requirements, Risks & Risk Controls </span> </a> </li> <li class="md-nav__item"> <a href="../../user-guide/trace-links/" class="md-nav__link"> <span class="md-ellipsis"> Trace Links & the Suspect Cycle </span> </a> </li> <li class="md-nav__item"> <a href="../../user-guide/traceability-workspace/" class="md-nav__link"> <span class="md-ellipsis"> The Traceability Workspace </span> </a> </li> <li class="md-nav__item"> <a href="../../user-guide/training/" class="md-nav__link"> <span class="md-ellipsis"> Training & Acknowledgements </span> </a> </li> </ul> </nav> </li> </ul> </nav> </div> </div> </div> <div class="md-sidebar md-sidebar--secondary" data-md-component="sidebar" data-md-type="toc" > <div class="md-sidebar__scrollwrap"> <div class="md-sidebar__inner"> <nav class="md-nav md-nav--secondary" aria-label="Table of contents"> <label class="md-nav__title" for="__toc"> <span class="md-nav__icon md-icon"></span> Table of contents </label> <ul class="md-nav__list" data-md-component="toc" data-md-scrollfix> <li class="md-nav__item"> <a href="#chapter-i--general-requirements-clauses-19" class="md-nav__link"> <span class="md-ellipsis"> Chapter I — General requirements (clauses 1–9) </span> </a> </li> <li class="md-nav__item"> <a href="#chapter-ii--requirements-regarding-design-and-manufacture-clauses-1022" class="md-nav__link"> <span class="md-ellipsis"> Chapter II — Requirements regarding design and manufacture (clauses 10–22) </span> </a> </li> <li class="md-nav__item"> <a href="#chapter-iii--information-supplied-with-the-device-clause-23" class="md-nav__link"> <span class="md-ellipsis"> Chapter III — Information supplied with the device (clause 23) </span> </a> </li> <li class="md-nav__item"> <a href="#notes" class="md-nav__link"> <span class="md-ellipsis"> Notes </span> </a> </li> </ul> </nav> </div> </div> </div> <div class="md-content" data-md-component="content"> <article class="md-content__inner md-typeset"> <a href="https://github.com/nburri/lqms/edit/main/docs/regulatory/mdr-annex-i-skeleton.md" title="Edit this page" class="md-content__button md-icon"> <svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 24 24"><path d="M10 20H6V4h7v5h5v3.1l2-2V8l-6-6H6c-1.1 0-2 .9-2 2v16c0 1.1.9 2 2 2h4zm10.2-7c.1 0 .3.1.4.2l1.3 1.3c.2.2.2.6 0 .8l-1 1-2.1-2.1 1-1c.1-.1.2-.2.4-.2m0 3.9L14.1 23H12v-2.1l6.1-6.1z"/></svg> </a> <h1 id="mdr-annex-i--gspr-authoring-skeleton-paraphrased">MDR Annex I — GSPR authoring skeleton (paraphrased)<a class="headerlink" href="#mdr-annex-i--gspr-authoring-skeleton-paraphrased" title="Permanent link">¶</a></h1> <blockquote> <p><strong>Purpose.</strong> An authoring aid for populating a scope's <strong>GSPR / applicability matrix</strong> document with <code>:::regulatory-ref</code> items (ADR-0084, Stage C / Wave 4). It lists the clause <strong>numbers + short house paraphrases</strong> of the General Safety and Performance Requirements (GSPRs) of <strong>Regulation (EU) 2017/745 (MDR), Annex I</strong>, so an author can create one <code>regulatory-ref</code> item per principle the scope claims and mark it <em>applicable</em> or <em>not-applicable (with justification)</em>.</p> <p><strong>This is NOT the regulation.</strong> Per the licensed-norms rule (ADR-0061 D-5, <code>conventions.md</code>), this file <strong>paraphrases</strong> the requirement structure with clause citations only; it reproduces no verbatim text beyond clause numbers and the public section titles. The authoritative wording is the MDR itself (Official Journal of the EU) — consult it, not this skeleton, when deciding applicability and drafting a justification. The tool ships the <code>regulatory-ref</code> <strong>type</strong> and (Wave 5) the conformity <strong>view</strong>; it never ships the regulation text as data.</p> <p><strong>How to use.</strong> For each clause your device engages, author a <code>:::regulatory-ref</code> item with <code>source = mdr-annex-i</code>, <code>clause = <number></code>, <code>applicability = applicable | not-applicable</code>, and — for a not-applicable clause — a <code>justification</code> (an unjustified N/A is a hard gap in the conformity view, OQ-8). Author <code>complies-with</code> links from the satisfying requirements / design elements to the item.</p> </blockquote> <h2 id="chapter-i--general-requirements-clauses-19">Chapter I — General requirements (clauses 1–9)<a class="headerlink" href="#chapter-i--general-requirements-clauses-19" title="Permanent link">¶</a></h2> <table> <thead> <tr> <th>Clause</th> <th>Section title (public heading)</th> <th>House paraphrase (one line)</th> </tr> </thead> <tbody> <tr> <td>1</td> <td>General safety and performance</td> <td>The device performs as intended and is safe for its intended purpose under normal conditions.</td> </tr> <tr> <td>2</td> <td>Reduction of risks — risk management</td> <td>Risks are reduced as far as possible without adversely affecting the benefit-risk ratio.</td> </tr> <tr> <td>3</td> <td>Risk management system</td> <td>A documented, iterative risk management process runs across the device lifecycle.</td> </tr> <tr> <td>4</td> <td>Risk control measures</td> <td>Risk controls follow the safety priority order (inherent design → protection → information).</td> </tr> <tr> <td>5</td> <td>Use-related risks</td> <td>Risks linked to ergonomics, the use environment, and the intended user are addressed.</td> </tr> <tr> <td>6</td> <td>Lifetime and performance over time</td> <td>Characteristics and performance are not adversely affected over the device's stated lifetime.</td> </tr> <tr> <td>7</td> <td>Transport and storage</td> <td>The device withstands the intended transport and storage conditions.</td> </tr> <tr> <td>8</td> <td>Benefit-risk acceptability</td> <td>The overall benefit outweighs the residual risks under normal conditions of use.</td> </tr> <tr> <td>9</td> <td>Combination with other devices / articles</td> <td>Device combinations are safe and do not impair the specified performance.</td> </tr> </tbody> </table> <h2 id="chapter-ii--requirements-regarding-design-and-manufacture-clauses-1022">Chapter II — Requirements regarding design and manufacture (clauses 10–22)<a class="headerlink" href="#chapter-ii--requirements-regarding-design-and-manufacture-clauses-1022" title="Permanent link">¶</a></h2> <table> <thead> <tr> <th>Clause</th> <th>Section title (public heading)</th> <th>House paraphrase (one line)</th> </tr> </thead> <tbody> <tr> <td>10</td> <td>Chemical, physical and biological properties</td> <td>Materials, biocompatibility, and released substances are controlled for the intended use.</td> </tr> <tr> <td>11</td> <td>Infection and microbial contamination</td> <td>Infection and contamination risks (incl. sterility, single-use, cleaning) are controlled.</td> </tr> <tr> <td>12</td> <td>Devices incorporating a medicinal substance</td> <td>A device incorporating a medicinal substance as ancillary action meets the added obligations.</td> </tr> <tr> <td>13</td> <td>Materials of biological origin</td> <td>Tissues/cells/derivatives of human or animal origin are sourced and processed safely.</td> </tr> <tr> <td>14</td> <td>Construction and interaction with the environment</td> <td>Safe interaction with other devices, environment, fields, and normal-use conditions.</td> </tr> <tr> <td>15</td> <td>Devices with a measuring function</td> <td>Measuring functions are accurate, precise, and stable within stated limits.</td> </tr> <tr> <td>16</td> <td>Protection against radiation</td> <td>Radiation exposure to users/patients/others is minimized and controlled.</td> </tr> <tr> <td>17</td> <td>Electronic programmable systems — software</td> <td>Software is developed and validated per the state of the art (dev lifecycle, risk, security).</td> </tr> <tr> <td>18</td> <td>Active devices and devices connected to them</td> <td>Active devices manage energy/failure/alarm behaviour safely, incl. connected-device risks.</td> </tr> <tr> <td>19</td> <td>Active implantable devices</td> <td>Additional requirements specific to active implantable devices.</td> </tr> <tr> <td>20</td> <td>Protection against mechanical and thermal risks</td> <td>Mechanical, moving-part, vibration, noise, and surface-temperature risks are controlled.</td> </tr> <tr> <td>21</td> <td>Devices supplying energy or substances</td> <td>Delivery of energy or substances is accurate, controllable, and fault-protected.</td> </tr> <tr> <td>22</td> <td>Devices for use by lay persons</td> <td>Lay-user devices account for the user's skill and available means; self-test where relevant.</td> </tr> </tbody> </table> <h2 id="chapter-iii--information-supplied-with-the-device-clause-23">Chapter III — Information supplied with the device (clause 23)<a class="headerlink" href="#chapter-iii--information-supplied-with-the-device-clause-23" title="Permanent link">¶</a></h2> <table> <thead> <tr> <th>Clause</th> <th>Section title (public heading)</th> <th>House paraphrase (one line)</th> </tr> </thead> <tbody> <tr> <td>23</td> <td>Label and instructions for use</td> <td>The information needed to identify and use the device safely is supplied with it.</td> </tr> <tr> <td>23.1</td> <td>General requirements for the information supplied</td> <td>Medium, format, location, and legibility of the supplied information are appropriate.</td> </tr> <tr> <td>23.2</td> <td>Information on the label</td> <td>The label carries the required identifying and safety particulars.</td> </tr> <tr> <td>23.3</td> <td>Information on the sterile packaging</td> <td>Sterile-barrier packaging carries the required sterility particulars.</td> </tr> <tr> <td>23.4</td> <td>Information in the instructions for use</td> <td>The IFU carries the required use, warning, residual-risk, and disposal particulars.</td> </tr> </tbody> </table> <h2 id="notes">Notes<a class="headerlink" href="#notes" title="Permanent link">¶</a></h2> <ul> <li><strong>Granularity.</strong> Author at whatever clause granularity the scope claims — a whole clause (e.g. <code>17</code>) or a sub-clause (e.g. <code>23.4</code>). The <code>clause</code> attribute is a free token, so the tool imposes no fixed depth.</li> <li><strong>Other regulations / standards.</strong> The same <code>regulatory-ref</code> type serves other sources (e.g. <code>source = iec-62304</code> for the software lifecycle standard's clauses); write a sibling skeleton per source as the need arises. MDR Annex I is the flagship conformity story (OQ-6a), authored first.</li> <li><strong>Renumbering caveat.</strong> Clause numbers follow the MDR as adopted; if a future corrigendum renumbers a section, update the <code>clause</code> token on the affected items (pre-1.0 content is freely restructurable).</li> </ul> </article> </div> <script>var target=document.getElementById(location.hash.slice(1));target&&target.name&&(target.checked=target.name.startsWith("__tabbed_"))</script> </div> <button type="button" class="md-top md-icon" data-md-component="top" hidden> <svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 24 24"><path d="M13 20h-2V8l-5.5 5.5-1.42-1.42L12 4.16l7.92 7.92-1.42 1.42L13 8z"/></svg> Back to top </button> </main> <footer class="md-footer"> <nav class="md-footer__inner md-grid" aria-label="Footer" > <a href="../../validation/templates/tool-risk-assessment/" class="md-footer__link md-footer__link--prev" aria-label="Previous: Tool-Risk Assessment — LQMS as a QMS Tool (TEMPLATE)"> <div class="md-footer__button md-icon"> <svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 24 24"><path d="M20 11v2H8l5.5 5.5-1.42 1.42L4.16 12l7.92-7.92L13.5 5.5 8 11z"/></svg> </div> <div class="md-footer__title"> <span class="md-footer__direction"> Previous </span> <div class="md-ellipsis"> Tool-Risk Assessment — LQMS as a QMS Tool (TEMPLATE) </div> </div> </a> <a href="../../user-guide/" class="md-footer__link md-footer__link--next" aria-label="Next: LQMS User Guide"> <div class="md-footer__title"> <span class="md-footer__direction"> Next </span> <div class="md-ellipsis"> LQMS User Guide </div> </div> <div class="md-footer__button md-icon"> <svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 24 24"><path d="M4 11v2h12l-5.5 5.5 1.42 1.42L19.84 12l-7.92-7.92L10.5 5.5 16 11z"/></svg> </div> </a> </nav> <div class="md-footer-meta md-typeset"> <div class="md-footer-meta__inner md-grid"> <div class="md-copyright"> <div class="md-copyright__highlight"> Built from <code>v0.9.56-4-g06c7f811</code> (commit <code>06c7f811</code>, 2026-09-09) — the same Markdown the repository ships. </div> </div> </div> </div> </footer> </div> <div class="md-dialog" data-md-component="dialog"> <div class="md-dialog__inner md-typeset"></div> </div> <script id="__config" type="application/json">{"base": "../..", "features": ["navigation.instant", "navigation.tracking", "navigation.top", "navigation.footer", "navigation.indexes", "toc.follow", "search.suggest", "search.highlight", "content.code.copy", "content.action.edit"], "search": "../../assets/javascripts/workers/search.6ce7567c.min.js", "translations": {"clipboard.copied": "Copied to clipboard", "clipboard.copy": "Copy to clipboard", "search.result.more.one": "1 more on this page", "search.result.more.other": "# more on this page", "search.result.none": "No matching documents", "search.result.one": "1 matching document", "search.result.other": "# matching documents", "search.result.placeholder": "Type to start searching", "search.result.term.missing": "Missing", "select.version": "Select version"}}</script> <script src="../../assets/javascripts/bundle.83f73b43.min.js"></script> </body> </html>