---
title: "When is a notified body needed under the EU Machinery Regulation?"
canonical_url: "https://www.sorena.io/artifacts/eu/machinery-regulation/faq/notified-bodies"
source_url: "https://www.sorena.io/artifacts/eu/machinery-regulation/faq/notified-bodies"
author: "Sorena AI"
description: "FAQ on when Machinery Regulation Annex I products need a notified body, how to find designated bodies, and what manufacturers still own."
published_at: "2026-05-09"
updated_at: "2026-05-09"
keywords:
  - "EU Machinery Regulation"
  - "Regulation (EU) 2023/1230"
  - "Annex I machinery"
  - "notified bodies"
  - "conformity assessment"
---
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# When is a notified body needed under the EU Machinery Regulation?

FAQ on when Machinery Regulation Annex I products need a notified body, how to find designated bodies, and what manufacturers still own.

*FAQ* *EU*

## Machinery Regulation FAQ Notified Bodies

Regulation (EU) 2023/1230 uses Annex I categories and conformity-assessment modules to decide when third-party assessment is required.

Use this FAQ to separate Annex I Part A, Annex I Part B, and non-Annex I machinery, then confirm any notified body through the EU Single Market Compliance Space listing.

A notified body is needed when the Machinery Regulation route chosen or required under Article 25 involves EU type-examination, full quality assurance, or unit verification. Annex I Part A products cannot use standalone internal production control. Annex I Part B products may use internal production control only when the product is designed and constructed under harmonised standards or common specifications specific to that category and covering all relevant essential health and safety requirements.

## When does Annex I require a notified body?

Start with Annex I. Part A covers categories that must use one of the third-party routes in Article 25(2): EU type-examination followed by conformity to type, full quality assurance, or unit verification. Those routes involve a notified body.

Part B gives manufacturers more room, but not always a self-assessment route. Article 25(3) allows internal production control only when the machinery or related product is designed and constructed in accordance with harmonised standards or common specifications specific to that category and covering all relevant essential health and safety requirements. If that coverage is missing or only partial, the manufacturer must use EU type-examination, full quality assurance, or unit verification.

If the product is not listed in Annex I, Article 25(4) points to internal production control. A notified body may still be useful commercially or technically, but the Regulation route itself is not the reason unless another applicable EU act requires it.

- Annex I Part A includes removable mechanical transmission devices and guards, vehicle servicing lifts, portable cartridge-operated fixing and impact machinery, certain machine-learning safety components, and machinery embedding such systems for safety functions.
- Annex I Part B includes listed woodworking and meat-processing saws, certain presses, moulding machinery, underground machinery, refuse trucks with compression mechanisms, lifting devices over 3 m fall hazard, protective devices, safety logic units, ROPS, and FOPS.
- Substantial modification can put the person making the modification into the manufacturer role, including the duty to apply the relevant Article 25 route.

Sources for this answer:

- [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Article 25 and Annex I define the conformity-assessment routes that determine whether a notified body is required.
- [European Commission machinery sector page](https://single-market-economy.ec.europa.eu/sectors/mechanical-engineering/machinery_en?ref=sorena.io) - Commission sector page identifying Machinery Regulation (EU) 2023/1230 and the official machinery-law context.

## How should a manufacturer find a notified body?

Use the EU Single Market Compliance Space notified-bodies search by legislation. Select Regulation (EU) 2023/1230 on machinery, then check bodies notified for the legislation and the relevant conformity-assessment activity before approaching one.

Do not treat a general certificate, test lab report, or consultant statement as a notified-body approval. The body should be notified for the machinery legislation and the assessment route you need, and its identification number should match the body named in the certificate, quality-system decision, unit-verification certificate, or EU declaration entry.

Keep a dated lookup record because notification scope can change. If a notified body is suspended, restricted, withdrawn, or ceases activity, the Regulation assigns follow-up handling to notifying authorities, but the manufacturer still needs a usable conformity record for the product.

- Search the Single Market Compliance Space by legislation and choose Regulation (EU) 2023/1230 on machinery.
- Check the notified body's legal name, identification number, country, legislation, and assessment scope against the module being used.
- Retain the lookup date, body profile, certificate or decision reference, and the product models or category covered.

Sources for this answer:

- [Single Market Compliance Space - notified bodies by legislation](https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/by-legislation?ref=sorena.io) - EU listing used to find bodies notified to carry out conformity assessments for Regulation (EU) 2023/1230 on machinery.
- [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Articles 26 to 42 cover notification, notified-body requirements, identification numbers, and notified-body obligations.

## What does the notified body assess?

Under Module B, the notified body examines the technical design, reviews technical documentation, checks representative specimens where required, and issues or refuses an EU type-examination certificate. The manufacturer then uses Module C to keep production in conformity with the approved type.

Under Module H, the notified body assesses the manufacturer's quality system, including design controls, product quality responsibilities, examinations, tests, records, and monitoring. It also performs surveillance through audits and may make unexpected visits.

Under Module G, the notified body examines and tests the individual machinery or related product, or has tests carried out, and issues a certificate for the examinations and tests performed. This is not a blanket approval for future variants.

- Module B output: EU type-examination certificate, evaluation report, and any additions or review actions tied to the approved type.
- Module H output: quality-system approval decision, audit reports, visit reports, test reports where applicable, and decisions on quality-system changes.
- Module G output: certificate for the unit and the notified body's identification number on the approved machinery or related product.

Sources for this answer:

- [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Annexes VII, IX, and X define what notified bodies examine under Modules B, H, and G.
- [Single Market Compliance Space - notified bodies by legislation](https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/by-legislation?ref=sorena.io) - Official lookup starting point for finding machinery notified bodies before using a third-party route.

## What must the manufacturer still own?

A notified-body certificate is not the whole compliance file. The manufacturer must still demonstrate that the product meets the applicable essential health and safety requirements in Annex III, draw up technical documentation, issue the EU declaration of conformity, affix the CE marking, and keep required records available for market surveillance.

Technical documentation should show the intended use, risk assessment, applicable EHSRs, protective measures, residual risks, drawings, standards or common specifications applied, other technical specifications used for uncovered requirements, test and inspection results, and production controls.

Changes matter after the first assessment. The manufacturer must account for changes in design, production, characteristics, harmonised standards, technical specifications, or common specifications. For Module B, modifications affecting conformity or certificate validity require additional notified-body approval.

- Keep the Annex I classification and Article 25 route rationale with the technical file.
- Keep the standards or common-specifications coverage map, including any partial application or uncovered EHSRs.
- Keep notified-body certificates, decisions, audit reports, test reports, and correspondence linked to the exact model, type, unit, or quality system.
- Reassess the route after material design, software, safety-function, production, supplier, standard, or intended-use changes.

Sources for this answer:

- [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Articles 10, 20, 21, 24, 25 and Annex IV define manufacturer duties, presumption of conformity, declarations, CE marking, route selection, and technical documentation.
- [European Commission harmonised standards for machinery](https://single-market-economy.ec.europa.eu/single-market/goods/european-standards/harmonised-standards/machinery-md_en?ref=sorena.io) - Commission machinery standards page used to check harmonised-standard references relevant to Machinery Directive/Machinery Regulation transition work.

## Primary sources

- [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Primary legal source for Annex I categories, Article 25 conformity routes, notified-body modules, manufacturer duties, declarations, CE marking, and technical documentation.
  - Quote: "Conformity assessment procedures for machinery and related products"
- [Single Market Compliance Space - notified bodies by legislation](https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/by-legislation?ref=sorena.io) - Official EU notified-body search by legislation, including Regulation (EU) 2023/1230 on machinery.
  - Quote: "find Bodies notified to carry out conformity assessments"
- [European Commission machinery sector page](https://single-market-economy.ec.europa.eu/sectors/mechanical-engineering/machinery_en?ref=sorena.io) - Commission machinery-sector context page for Machinery Regulation (EU) 2023/1230, market surveillance, and notified-body information.
  - Quote: "Machinery Regulation (EU) 2023/1230"
- [European Commission harmonised standards for machinery](https://single-market-economy.ec.europa.eu/single-market/goods/european-standards/harmonised-standards/machinery-md_en?ref=sorena.io) - Commission machinery harmonised-standards page used for checking standards references and presumption-of-conformity context.
  - Quote: "harmonised standards for machinery"

## Topic Guides

- [Declaration of Conformity vs Declaration of Incorporation | Machinery Regulation FAQ](/artifacts/eu/machinery-regulation/faq/doc-and-doi.md): FAQ on when machinery needs an EU Declaration of Conformity and when partly completed machinery needs an EU Declaration of Incorporation under Regulation (EU) 2023/1230.
- [Directive 2006/42/EC to Machinery Regulation transition](/artifacts/eu/machinery-regulation/transition-from-directive-2006-42-ec.md): Transition guide for moving EU machinery files from Directive 2006/42/EC to Regulation (EU) 2023/1230, focused on the 20 January 2027 changeover, pipeline products, declarations, standards, technical documentation, software, cybersecurity, and digital instructions.
- [EU Machinery Regulation Applicability Test](/artifacts/eu/machinery-regulation/applicability-test.md): Test whether a product is machinery, a related product, partly completed machinery, a safety component, substantially modified, excluded, or covered by overlapping EU product laws.
- [EU Machinery Regulation compliance](/artifacts/eu/machinery-regulation/compliance.md): Machinery Regulation compliance checklist covering scope, EHSR risk assessment, technical documentation, instructions, conformity assessment, EU declarations, CE marking, software, transition, and market surveillance.
- [EU Machinery Regulation compliance checklist](/artifacts/eu/machinery-regulation/checklist.md): Checklist for Regulation (EU) 2023/1230 covering scope, EHSR risk assessment, technical documentation, instructions, conformity assessment, EU declarations, CE marking, digital duties, transition, and market surveillance.
- [EU Machinery Regulation deadlines and compliance calendar](/artifacts/eu/machinery-regulation/deadlines-and-compliance-calendar.md): Calendar for Regulation (EU) 2023/1230 dates, Directive 2006/42/EC transition, release documentation gates, standards monitoring, and substantial-modification reviews.
- [EU Machinery Regulation FAQ](/artifacts/eu/machinery-regulation/faq.md): Answers to Machinery Regulation questions on scope, partly completed machinery, Annex I categories, Article 25 conformity assessment, digital instructions, software, cybersecurity, transition, CE files, and overlap with other EU product laws.
- [EU Machinery Regulation Partly Completed Machinery](/artifacts/eu/machinery-regulation/partly-completed-machinery.md): What counts as partly completed machinery under Regulation (EU) 2023/1230, what documents travel with it, and where the final assembler takes over.
- [EU Machinery Regulation requirements](/artifacts/eu/machinery-regulation/requirements.md): Requirements under Regulation (EU) 2023/1230: machinery scope, EHSR risk assessment, technical documentation, instructions, conformity assessment, EU declaration, CE marking, software evidence, transition, and surveillance.
- [EU Machinery Regulation Safety Components](/artifacts/eu/machinery-regulation/safety-components.md): Definition, scope, conformity assessment, technical documentation, declaration, CE marking, and grounded examples for safety components under Regulation (EU) 2023/1230.
- [EU Machinery Regulation scope and machine categories](/artifacts/eu/machinery-regulation/scope-and-machine-categories.md): Scope guide for Regulation (EU) 2023/1230 covering machinery, related products, partly completed machinery, Annex I categories, exclusions, substantial modification, and category evidence.
- [EU Machinery Regulation substantial modification decision workflow](/artifacts/eu/machinery-regulation/substantial-modification-workflow.md): Workflow for assessing substantial modification under Regulation (EU) 2023/1230: change facts, hazard and risk impact, manufacturer obligations, conformity assessment, CE marking, and evidence.
- [EU Machinery Regulation vs LVD](/artifacts/eu/machinery-regulation/machinery-vs-lvd.md): Compare the EU Machinery Regulation and Low Voltage Directive boundary for machinery EHSRs, electrical risks, excluded electrical products, CE documentation, and evidence reuse.
- [EU Machinery Regulation vs Market Surveillance Regulation: compliance comparison](/artifacts/eu/machinery-regulation/machinery-vs-msr.md): Compare Machinery Regulation product compliance duties with EU MSR market surveillance duties, authority requests, online sales, corrective action and evidence records.
- [EU Machinery Regulation: autonomous mobile and collaborative machinery](/artifacts/eu/machinery-regulation/autonomous-mobile-and-collaborative-machinery.md): Grounded guide to Regulation (EU) 2023/1230 requirements for autonomous mobile machinery, human-machine interaction, controls, software, cybersecurity, risk assessment, technical documentation, and conformity routes.
- [EU Machinery Regulation: when does a modification constitute substantial modification?](/artifacts/eu/machinery-regulation/substantial-modification.md): Guide to substantial modification under Regulation (EU) 2023/1230: change triggers, risk assessment, EHSRs, technical documentation, conformity assessment, CE marking, and records.
- [EU Machinery Risk Assessment Method](/artifacts/eu/machinery-regulation/risk-assessment-method.md): How to document an EU Machinery Regulation risk assessment: ISO 12100 hazard identification, EHSR mapping, risk reduction, residual risk, software, cybersecurity, and technical-file evidence.
- [How to map Annex III EHSRs under the EU Machinery Regulation | Machinery Regulation FAQ](/artifacts/eu/machinery-regulation/faq/annex-iii-ehsr.md): FAQ on mapping Annex III essential health and safety requirements to hazards, risk reduction, software controls, technical documentation, and Annex I classification under Regulation (EU) 2023/1230.
- [Machinery CE documentation template for Regulation (EU) 2023/1230](/artifacts/eu/machinery-regulation/machinery-ce-documentation-template.md): Template fields for Machinery Regulation CE documentation: product identity, scope, EHSR risk assessment, standards, tests, instructions, EU declaration, CE marking, notified body route, software, cyber, and substantial modification checks.
- [Machinery Regulation and EU AI Act overlap for AI-enabled safety functions](/artifacts/eu/machinery-regulation/faq/ai-act-overlap.md): FAQ on Machinery Regulation overlap with the EU AI Act for self-evolving or machine-learning safety functions, Annex I categories, standards work, and technical documentation boundaries.
- [Machinery Regulation Annex I conformity route workflow](/artifacts/eu/machinery-regulation/annex-i-route-workflow.md): Classify machinery against Annex I Part A and Part B, choose the Article 25 conformity assessment route, and assemble the technical evidence file.
- [Machinery Regulation Annex I high-risk categories](/artifacts/eu/machinery-regulation/annex-i-and-high-risk-machinery.md): Explain what Annex I does under Regulation (EU) 2023/1230, which listed machinery categories trigger special conformity routes, and what evidence to keep.
- [Machinery Regulation category and scope checks](/artifacts/eu/machinery-regulation/category-and-scope-workflow.md): Check whether a product is machinery, a related product, partly completed machinery, a safety component, excluded from scope, or listed in Annex I under Regulation (EU) 2023/1230.
- [Machinery Regulation conformity assessment and CE marking](/artifacts/eu/machinery-regulation/conformity-assessment-and-ce.md): EU Machinery Regulation guide to Article 25 conformity assessment routes, Annex I machinery categories, technical documentation, EU declarations, CE marking, and instructions.
- [Machinery Regulation cybersecurity evidence FAQ](/artifacts/eu/machinery-regulation/faq/cybersecurity.md): What cybersecurity evidence connected or software-enabled machinery should keep for protection against corruption, safety-related control systems, and machinery risk assessment.
- [Machinery Regulation digital instructions](/artifacts/eu/machinery-regulation/digital-instructions.md): EU Machinery Regulation guide to digital instructions for use: access marking, print and download access, paper copies, non-professional safety information, languages, and records.
- [Machinery Regulation penalties and enforcement](/artifacts/eu/machinery-regulation/penalties-and-fines.md): EU Machinery Regulation enforcement guide covering Member State penalty rules, corrective action, market surveillance powers, and cross-border authority cooperation.
- [Machinery Regulation related products scope guide](/artifacts/eu/machinery-regulation/related-products.md): Classify EU Machinery Regulation related products, including interchangeable equipment, safety components, lifting accessories, lifting chains, ropes, webbing, and removable transmission devices.
- [Machinery Regulation software and cybersecurity considerations](/artifacts/eu/machinery-regulation/software-and-cybersecurity-considerations.md): How Regulation (EU) 2023/1230 treats safety-related software, control systems, corruption protection, technical documentation, and cyber-safety risk evidence.
- [Machinery Regulation Technical Documentation and Technical File](/artifacts/eu/machinery-regulation/technical-documentation-and-technical-file.md): What to keep in the EU Machinery Regulation technical file: product identification, risk assessment, EHSR mapping, standards, tests, instructions, declarations, software evidence, retention, and notified-body records.
- [Machinery Regulation technical file acceptance workflow](/artifacts/eu/machinery-regulation/technical-file-acceptance-workflow.md): Release-gate workflow for accepting an EU Machinery Regulation technical file: scope, EHSR risk evidence, standards, tests, declarations, notified-body records, software, cyber, and signoff.
- [Machinery Regulation Timeline and Transition: practical guide](/artifacts/eu/machinery-regulation/timeline-and-transition.md): EU Machinery Regulation guide to Timeline and Transition with scope decisions, owner actions, evidence records, source-linked citations, and practical next steps.
- [Machinery Regulation vs EMC Directive](/artifacts/eu/machinery-regulation/machinery-vs-emc.md): Compare EU machinery safety duties with EMC duties for equipment, CE documentation, harmonised standards, declarations, and combined technical files.
- [Machinery Regulation vs EU AI Act: machinery safety overlap](/artifacts/eu/machinery-regulation/machinery-regulation-vs-eu-ai-act.md): A grounded comparison of the EU Machinery Regulation and EU AI Act for machinery with AI-enabled safety functions, software, cyber-safety and technical documentation overlap.
- [Machinery Regulation vs Machinery Directive](/artifacts/eu/machinery-regulation/machinery-regulation-vs-machinery-directive.md): Grounded comparison of Regulation (EU) 2023/1230 and Directive 2006/42/EC across legal form, timing, scope, digital instructions, cybersecurity, conformity assessment, documentation, and CE marking.
- [Machinery vs RED comparison](/artifacts/eu/machinery-regulation/machinery-vs-red.md): Compare EU Machinery Regulation and Radio Equipment Directive boundaries for machinery safety, radio equipment scope, CE documentation, and shared evidence.
- [What counts as machinery under Regulation (EU) 2023/1230?](/artifacts/eu/machinery-regulation/faq/machinery-definition.md): FAQ on the Machinery Regulation definition of machinery, including assemblies, drive systems, missing components, software, related products, partly completed machinery, safety components, and exclusions.
- [When can a software update affect Machinery Regulation compliance?](/artifacts/eu/machinery-regulation/faq/software-updates.md): FAQ on when machinery software updates can trigger Machinery Regulation review, including safety functions, substantial modification, corruption protection, instructions, and CE technical-file evidence.
- [When does used or modified machinery need a new conformity assessment? | Machinery Regulation FAQ](/artifacts/eu/machinery-regulation/faq/used-and-modified-machinery.md): FAQ on used and modified machinery under Regulation (EU) 2023/1230, including substantial modification, first EU use, technical documentation, and market surveillance evidence.
- [Which Article 25 conformity assessment module applies? | EU Machinery Regulation FAQ](/artifacts/eu/machinery-regulation/faq/article-25-modules.md): FAQ on Article 25 of Regulation (EU) 2023/1230: Module A, Module B plus C, Module H, Module G, Annex I triggers, notified body involvement, and technical file evidence.

*Recommended next step*

*Placement: after implementation section*

## Check your Machinery Regulation assessment route

Map the product to Annex I, confirm standards coverage, choose the Article 25 route, and keep notified-body records tied to the exact machinery model or unit.

- [Open Research Copilot](/solutions/research-copilot.md): Answer Machinery Regulation scope, route, and evidence questions with cited outputs.
- [Talk through implementation](/contact.md): Review Annex I classification, standards coverage, notified-body records, and manufacturer-owned evidence.


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