> ## Documentation Index
> Fetch the complete documentation index at: https://docs.roboticks.io/llms.txt
> Use this file to discover all available pages before exploring further.

# EU MR 2023/1230 Conformity Assessment

> Full workflow for EU MR 2023/1230 (self-propelled machinery) conformity. Risk assessment, harmonised standards stack, technical file, Declaration of Conformity — and Roboticks's role in each.

# EU MR 2023/1230 Conformity Assessment

This is the meta-pattern that wraps every product-specific pattern when shipping into the EU. It covers the full conformity assessment workflow under the **EU Machinery Regulation 2023/1230** (applies January 20, 2027), with emphasis on **self-propelled machinery** — AMRs, mobile manipulators, autonomous service robots — where the substantial-modification, AI-component, and cybersecurity provisions land hardest.

Read alongside the product-specific pattern for your machinery class ([industrial robot](/compliance/industrial-robot-iso-10218), [cobot](/compliance/cobot-iso-ts-15066), [AMR](/compliance/amr-iso-3691-4)).

<Warning>
  **Roboticks is audit-readiness tooling, not a certified toolchain.** We assemble the evidence your notified body, certification body, or QA process ingests. We do not replace tool qualification (DO-178C, ISO 26262-8 TCL) and we do not issue conformity assessments. Verify the regulatory interpretations on this page against the standard text and your accredited assessor.
</Warning>

## Scenario

You ship machinery into the EU after January 20, 2027. You need to claim conformity under EU MR 2023/1230 and (for Annex I high-risk machinery) involve a notified body. The conformity assessment culminates in a **Declaration of Conformity (DoC)** that you issue and CE-marking you affix.

## The conformity-assessment workflow

```mermaid theme={null}
%%{init: {"theme": "neutral", "themeVariables": {"primaryColor": "#4040ff"}} }%%
flowchart TB
    RA["Risk assessment<br/>(ISO 12100)"] --> Harm["Harmonised standards selection"]
    Harm --> Derive["Requirement derivation<br/>(Roboticks)"]
    Derive --> Verify["Verification<br/>(Roboticks)"]
    Verify --> Pack["Evidence pack<br/>(Roboticks)"]
    Pack --> TF["Technical file<br/>(Annex IV)"]
    Tools["Tools, drawings,<br/>instructions, supplier certs"] --> TF
    TF --> NB["Notified body<br/>(Annex IX or X)"]
    TF --> DoC["Declaration of Conformity"]
    DoC --> CE["CE marking"]
```

## Prerequisites

| Element                                       | Owner                               | Roboticks role                                                       |
| --------------------------------------------- | ----------------------------------- | -------------------------------------------------------------------- |
| Risk assessment per ISO 12100                 | Safety engineer                     | Ingests hazard list as `hazards.yaml`; links requirements to hazards |
| Harmonised standards selection                | Compliance lead + safety engineer   | Pinned in Roboticks; tracked by the publication feed                 |
| Requirement derivation                        | Engineering + compliance            | Native Roboticks function                                            |
| Verification                                  | Engineering                         | Native Roboticks function                                            |
| Design drawings and engineering documentation | Mechanical / electrical engineering | Attach to pack as supplementary; not authored by Roboticks           |
| Instructions for use                          | Technical writing                   | Off-platform; reference from pack                                    |
| Supplier certifications for safety components | Component suppliers                 | Reference in `architecture.yaml`                                     |
| Quality management system documentation       | Quality function (ISO 9001)         | Off-platform                                                         |
| Notified body engagement (Annex I machinery)  | Compliance                          | They ingest the evidence pack as part of the technical file          |
| Declaration of Conformity                     | Compliance / company officer        | Off-platform; pack provides verification evidence                    |
| CE marking                                    | Compliance                          | Off-platform                                                         |

## The harmonised standards stack

The exact stack depends on machinery class. For most robotics applications:

| Standard                      | Coverage                                        |
| ----------------------------- | ----------------------------------------------- |
| **ISO 12100**                 | Risk assessment methodology                     |
| **EN ISO 13849-1**            | PL determination, Categories                    |
| **IEC 62061**                 | SIL CL determination (alternative to ISO 13849) |
| **ISO 10218-1:2025**          | Industrial robots (manufacturer side)           |
| **ISO 10218-2:2025**          | Industrial robot systems (integrator side)      |
| **ISO/TS 15066**              | Cobot PFL                                       |
| **ISO 3691-4**                | Driverless industrial trucks / AMRs             |
| **IEC 61496**                 | Protective equipment (scanners, light curtains) |
| **EN 60204-1**                | Electrical equipment of machinery               |
| **EU AI Act** (Reg 2024/1689) | AI safety components (from 2 August 2027)       |

Conformance to harmonised standards confers a **presumption of conformity** to the corresponding EHSRs of EU MR 2023/1230. The presumption is rebuttable; the notified body assessment is the rebuttal opportunity.

## Project setup

<Steps>
  <Step title="Pin EU MR 2023/1230 and the harmonised stack">
    ```bash theme={null}
    rbtk standard template apply industrial-robot-eu  # or cobot-eu, amr-eu
    rbtk standard pin eu-mr-2023-1230 --project acme/firmware
    ```
  </Step>

  <Step title="Ingest the risk assessment">
    Hazard list → `roboticks/hazards.yaml`. See [ISO 12100](/standards/iso-12100).
  </Step>

  <Step title="Author requirements derived from EHSRs">
    For machinery-specific obligations not fully covered by the harmonised stack, derive requirements directly from EU MR 2023/1230 Annex III EHSRs. See [EU MR 2023/1230](/standards/eu-mr-2023-1230#example-derived-requirement).
  </Step>

  <Step title="Author cybersecurity and AI requirements">
    EU MR 2023/1230's cybersecurity provisions (EHSR 1.1.9) and AI provisions (EHSR 1.1.6, 1.2.1) require explicit requirement-and-test coverage. The harmonised stack does not fully cover them; derive directly from the Regulation.
  </Step>
</Steps>

## Technical file structure

Annex IV of EU MR 2023/1230 prescribes what the technical file must contain. The mapping to Roboticks:

| Annex IV requirement                               | Roboticks contribution                                                  |
| -------------------------------------------------- | ----------------------------------------------------------------------- |
| **Risk assessment**                                | `hazards.yaml`, rendered in the evidence pack PDF                       |
| **List of EHSRs and harmonised standards applied** | Pinned-standards section of the pack                                    |
| **Design and manufacturing drawings**              | Attach as supplementary artefacts; not authored                         |
| **Description of safety functions**                | `architecture.yaml`, rendered in the pack                               |
| **Calculations and test results**                  | Test-results section, coverage section, MCAPs (referenced)              |
| **Software safety analysis**                       | Coverage, SARIF, requirement-test traceability                          |
| **Quality management system documentation**        | Off-platform; reference in DoC                                          |
| **Components used (with certifications)**          | `architecture.yaml`; referenced supplier certs                          |
| **Instructions for use**                           | Off-platform; reference in DoC                                          |
| **Cybersecurity analysis (new under 2023/1230)**   | SBOM, SARIF, fuzz-test evidence                                         |
| **AI safety analysis (new under 2023/1230)**       | AI-related requirements with their test evidence; MCAPs of AI behaviour |

The evidence pack is the **verification evidence** portion of the technical file — typically the most voluminous portion, and the one notified bodies most scrutinise. The non-verification portions are off-platform; you assemble them around the pack.

## Conformity-assessment routes

For Annex I high-risk machinery (the list includes safety components, machinery embodying machine-learning, etc.), the notified body involvement is mandatory. The routes:

* **Annex IX — EU-type examination + production-conformity surveillance** — notified body examines the type, then audits production-monitoring evidence annually.
* **Annex X — Full quality assurance** — notified body audits the quality management system and design dossier.

Roboticks evidence packs feed both routes. For Annex IX, the pack supports both the EU-type examination (the design dossier) and the surveillance audits (post-release production-conformity evidence). For Annex X, the pack supports the design-dossier examination.

For machinery not in Annex I, **self-assessment** is the route. The pack is your internal evidence; you issue the DoC on your own determination.

## Cutting the conformity release

When you are ready to declare conformity:

<Steps>
  <Step title="Cut the conformity release">
    `rbtk release cut --tag conformity-2027-01-20 --commits …`. Use a tagging convention that makes conformity releases identifiable.
  </Step>

  <Step title="Run full verification">
    Every required test, against the pinned commit set. Resolve every gap. Acknowledged gaps must have documented rationale.
  </Step>

  <Step title="Generate the evidence pack">
    All three formats; include screenshots if available.
  </Step>

  <Step title="Assemble the technical file around it">
    Off-platform. Drawings, instructions, supplier certs, risk-assessment narrative.
  </Step>

  <Step title="Engage the notified body (if Annex I)">
    Hand over the pack via the [customer-handoff procedure](/evidence/customer-handoff).
  </Step>

  <Step title="On notified-body sign-off, issue the DoC and affix CE">
    Off-platform; the pack is the verification-evidence record.
  </Step>

  <Step title="Mark the release shipped">
    `rbtk release ship conformity-2027-01-20`. The 10-year retention clock starts.
  </Step>
</Steps>

## Surveillance and re-conformity

Under Annex IX, annual production-conformity surveillance is the norm. Roboticks supports this by:

* Producing evidence packs for every release shipped during the surveillance period.
* Maintaining the hash chain so the assessor can verify the historical integrity in a single command.
* Surfacing standard amendments that occurred during the surveillance period and the re-conformity actions taken.

When a pinned standard amends, follow [Re-conformity on amendment](/compliance/re-conformity-on-amendment).

## Next steps

<CardGroup cols={2}>
  <Card title="EU MR 2023/1230 standard" icon="flag" href="/standards/eu-mr-2023-1230">
    The Regulation reference.
  </Card>

  <Card title="Industrial robot pattern" icon="industry" href="/compliance/industrial-robot-iso-10218">
    Product-specific layer for industrial robots.
  </Card>

  <Card title="AMR pattern" icon="truck" href="/compliance/amr-iso-3691-4">
    Product-specific layer for AMRs.
  </Card>

  <Card title="Re-conformity workflow" icon="rotate" href="/compliance/re-conformity-on-amendment">
    Handling amendments after the conformity release.
  </Card>
</CardGroup>