Annex IV machinery under the Machinery Directive: list, procedures, notified body
Whether press brake, vehicle servicing lift or light curtain: if a product is listed in Annex IV of Machinery Directive 2006/42/EC, stricter rules apply to its conformity assessment. This article shows the complete list of the 23 categories, explains with a decision tree when you may assess conformity yourself and when a notified body is mandatory, and what changes with the EU Machinery Regulation from 2027.
What does Annex IV mean legally?
The Machinery Directive 2006/42/EC generally leaves conformity assessment to the manufacturer: whoever places a machine on the market assesses for themselves whether it meets the essential health and safety requirements (EHSRs), without an external body. For the categories listed in Annex IV the legislator makes an exception: here the hazard potential is so high that Article 12(3) and (4) prescribe stricter procedures.
Typical for Annex IV categories is the operator’s immediate proximity to the danger zone: many entries apply expressly only with manual loading, manual unloading or manual feed. A fully automatic press line without manual insertion therefore does not fall under item 9; the same press with a manual loading station does. Such distinguishing criteria (also stroke, speed or fall height) decide the classification in the individual case and should be checked against the official wording.
Important: Annex IV does not only cover complete machinery. Safety components such as protective devices designed to detect the presence of persons, logic units to ensure safety functions and roll-over and falling-object protective structures (ROPS/FOPS) are on the list too, as are removable mechanical transmission devices including their guards.
Annex IV machinery: the complete list of the 23 categories
The following overview groups all 23 categories by topic. The official wording of Annex IV is always decisive. The distinguishing criteria mentioned (e.g. manual loading) are part of the definition and decide whether your product is covered.
Wood and meat working (items 1 to 8)
- 1Circular saws (single- or multi-blade) for working with wood and material with similar physical characteristics or for working with meat and material with similar physical characteristics
- 2Hand-fed surface planing machines for woodworking
- 3Thicknessers for one-side dressing with manual loading and/or unloading for woodworking
- 4Band-saws with manual loading and/or unloading for working with wood or meat and material with similar physical characteristics
- 5Combined machines of the types referred to in items 1 to 4 and 7 for working with wood
- 6Hand-fed tenoning machines with several tool holders for woodworking
- 7Hand-fed vertical spindle moulding machines for working with wood and material with similar physical characteristics
- 8Portable chainsaws for woodworking
Metal, plastics and rubber processing (items 9 to 11)
- 9Presses, including press-brakes, for the cold working of metals, with manual loading and/or unloading, whose movable working parts may have a travel exceeding 6 mm and a speed exceeding 30 mm/s
- 10Injection or compression plastics-moulding machinery with manual loading or unloading
- 11Injection or compression rubber-moulding machinery with manual loading or unloading
Underground working and refuse collection (items 12 and 13)
- 12Machinery for underground working: locomotives and brake-vans, and hydraulic-powered roof supports
- 13Manually loaded trucks for the collection of household refuse incorporating a compression mechanism
Power transmission, lifting of loads and persons (items 14 to 18)
- 14Removable mechanical transmission devices including their guards
- 15Guards for removable mechanical transmission devices
- 16Vehicle servicing lifts
- 17Devices for the lifting of persons or of persons and goods involving a hazard of falling from a vertical height of more than three metres
- 18Portable cartridge-operated fixing and other impact machinery
Safety components (items 19 to 23)
- 19Protective devices designed to detect the presence of persons, e.g. light curtains, laser scanners, pressure-sensitive mats
- 20Power-operated interlocking movable guards designed to be used as safeguards in machinery referred to in items 9, 10 and 11
- 21Logic units to ensure safety functions, e.g. configurable safety controllers
- 22Roll-over protective structures (ROPS)
- 23Falling-object protective structures (FOPS)
Check the classification carefully when in doubt
The distinguishing criteria are legally decisive: a press with a 5 mm stroke does not fall under item 9, a person-lifting device with a 2.5 m fall height not under item 17. Document the result of the check in the technical file, even if it is negative.
Decision tree: which conformity assessment procedure applies?
Article 12 of the Machinery Directive regulates the procedure in three tiers. Two questions are decisive: Is the machine listed in Annex IV? And if so: was it built fully in accordance with harmonised standards that cover all the relevant EHSRs?
Case 1 · Art. 12(2)
Machine is NOT listed in Annex IV
The manufacturer carries out the conformity assessment with internal checks on the manufacture per Annex VIII entirely on their own. This applies to the vast majority of all machinery.
No notified body required.
Case 2 · Art. 12(3)
Annex IV machine built fully in accordance with harmonised standards
Prerequisite: harmonised standards exist that cover all the relevant EHSRs of the machine, and the machine was manufactured in accordance with them. The manufacturer then has the choice of three procedures:
- internal checks on the manufacture per Annex VIII (without a notified body),
- EC type-examination per Annex IX plus internal checks per Annex VIII section 3, or
- full quality assurance per Annex X.
The notified body is therefore an option here, not an obligation. This is often misunderstood in practice.
Case 3 · Art. 12(4)
Annex IV machine without (full) application of standards
If harmonised standards were not applied or only partly applied, do not cover all the relevant EHSRs or simply do not exist, only two procedures remain, both with a notified body:
- EC type-examination per Annex IX plus internal checks per Annex VIII section 3, or
- full quality assurance per Annex X.
Even a deliberate deviation from a relevant type-C standard can mean the switch from case 2 to case 3.
In practice this means: the question “Do we need a notified body?” can only be answered once the Annex IV classification and the standards situation are settled. How the presumption of conformity via harmonised standards works is explained in our step-by-step guide to CE marking.
Notified body for machinery: role, selection, NANDO database
A notified body is an independent test organisation notified by a member state. For Annex IV machinery it takes on two tasks depending on the procedure: in the EC type-examination (Annex IX) it examines a representative specimen of the machine together with the technical documentation and certifies conformity with the Directive. In full quality assurance (Annex X) it assesses and monitors the manufacturer’s quality assurance system for design, manufacture and testing.
An EC type-examination certificate is not valid indefinitely: under Annex IX section 9.3 the manufacturer must request a review of its validity every five years; the notified body renews it only if the type still corresponds to the current state of the art. Modifications to the approved type must be reported to the body.
Which bodies are notified for which products is shown in the European Commission’s public NANDO database (New Approach Notified and Designated Organisations). There you filter by legal act, Directive 2006/42/EC or, in future, Regulation (EU) 2023/1230, and see the exact scope of notification for each body. When selecting, check:
Scope of notification: Is the body notified precisely for your Annex IV category and the desired procedure (Annex IX or X)? From 2027 additionally: is there already a notification for Machinery Regulation (EU) 2023/1230?
Sector experience: A body that regularly tests your product type knows the relevant type-C standards and typical findings. That shortens the procedure.
Capacity and dates: Type-examinations need lead time. Ask about processing times early and plan them into the project schedule.
Language and availability: Test reports, queries and audits run more smoothly when the body communicates in your working language.
Responsibility stays with the manufacturer
Even with a type-examination certificate, the manufacturer declares conformity themselves and affixes the CE marking on their own responsibility. The notified body examines. It relieves the manufacturer of neither the risk assessment nor product liability. The same applies to software tools: CE-Copilot supports classification and documentation but does not replace a notified body.
Transition to the Machinery Regulation 2027: Annex IV becomes Annex I (Parts A and B)
From 20 January 2027 the EU Machinery Regulation (EU) 2023/1230 replaces the Machinery Directive. The list of particularly hazardous machinery moves from Annex IV to Annex I of the Regulation and is split into two parts with consequences of different severity (Article 25 of the Regulation):
Annex I Part A: notified body always mandatory (6 categories)
For Part A products the previous “standards privilege” disappears: internal production control is no longer permitted, even if harmonised standards are applied in full. Only procedures involving a notified body remain: EU type-examination (module B) followed by conformity to type (module C), full quality assurance (module H) or the new unit verification (module G). Part A comprises:
- removable mechanical transmission devices,
- guards for removable mechanical transmission devices,
- vehicle servicing lifts,
- portable cartridge-operated fixing and other impact machinery,
- safety components with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions,
- machinery that embeds systems of this kind, provided the systems were not placed on the market independently (only in respect of those systems).
Annex I Part B: logic as before (19 categories)
Part B takes over the remaining categories of the former Annex IV, from woodworking machinery through presses and injection moulding machines to the safety components. Here the familiar rule remains: whoever applies all the relevant harmonised standards in full and thereby covers all the relevant requirements may continue to self-assess with internal production control (module A). Otherwise a notified body must be involved (module B+C, H or G).
In practical terms: manufacturers of vehicle servicing lifts, transmission devices or cartridge-operated fixing tools who rely on full application of standards today will need a notified body without exception from 20 January 2027. Because certificates and audit dates need lead time, this switch should not be postponed until 2027. Also new is unit verification (module G) as an option, interesting for special-purpose machinery built in quantities of one. Whether your product falls under Part A or Part B, you clarify in two steps in the interactive Part A/Part B quick check.
Common misconceptions about Annex IV
“Annex IV always means type-examination.”
Wrong (under the Machinery Directive). If harmonised standards covering all the relevant EHSRs are applied in full, internal checks on the manufacture suffice (Art. 12(3)). But be careful: for the six categories in Annex I Part A of the Machinery Regulation the sentence is true from 2027: there, the third party is mandatory without exception.
“Annex IV only concerns complete machines.”
Wrong. Five of the 23 categories are safety components (presence detection, interlocking guards, logic units, ROPS, FOPS); add to that removable mechanical transmission devices and their guards. Suppliers of such components are affected too.
“We apply most of the type-C standard, that is enough.”
Wrong. The choice under Art. 12(3) requires the full application of standards that cover all the relevant EHSRs. Any deviation, even a technically well-founded one, leads into the procedure under paragraph 4 with a notified body.
“The notified body awards the CE mark.”
Wrong. The manufacturer affixes the CE marking themselves after drawing up the EC Declaration of Conformity. The notified body certifies the type or the quality assurance system. Legal responsibility stays with the manufacturer.
“One type-examination, valid forever.”
Wrong. The validity of the EC type-examination certificate must be reviewed every five years (Annex IX section 9.3); it is renewed only if the type still corresponds to the state of the art. Changes to the product can also trigger a reassessment.
Practical tips for design engineers and CE officers
Bring the Annex IV check into the concept phase: Clarify the classification before the design is fixed. The procedure determines schedule and budget: a type-examination that only comes to light shortly before delivery costs months.
Always document the result: Record the Annex IV check with reasoning in the technical file. Even a negative result (“not covered by item 9, as no manual loading”) protects you when market surveillance asks.
Prove distinguishing criteria measurably: Stroke, speed, fall height, loading method: back up the values your classification relies on with design data.
Keep the application of standards complete: The choice under Art. 12(3) stands and falls with proof of full application of the standards. The presumption of conformity moreover applies only to harmonised standards listed in the Official Journal of the EU. Keep your list of standards current and watch for replacement editions.
Clarify Machinery Regulation exposure now: Check whether your product falls under Annex I Part A from 2027. If so: approach a notified body early and structure your documents according to the new modules.
CE-Copilot takes the first step off your desk: the AI standards finder automatically recognises whether your machine description falls into an Annex IV category and points out the applicable conformity assessment procedure, under the Machinery Directive as well as under Annex I Part A/B of the Machinery Regulation. In the declaration of conformity the procedure is then set explicitly: the procedure selector offers the routes permitted under Art. 12 of the Directive or Art. 25 of the Regulation, and whoever chooses type-examination is asked for the notified body, its identification number and the certificate number before the declaration counts as complete. The risk assessment per EN ISO 12100, the standards tracker for changes to standards and the declaration of conformity as PDF or Word build on that. Where an examination and certificate by a notified body is prescribed, this expressly does not replace it.
Conclusion: classification first, procedure second
Annex IV is not a blanket obligation to undergo type-examination but a switch: the classification decides which conformity assessment procedures are open to you, and the standards situation decides whether you may choose the leanest of them. Whoever clarifies both early and in writing avoids expensive surprises during the project.
With the Machinery Regulation from 20 January 2027 the situation tightens in specific places: for the six categories in Annex I Part A there is no way around the notified body any more. For all other Annex IV categories the proven logic remains: full application of standards remains the key to self-assessment.
Annex IV check built into the standards finder
Describe your machine: CE-Copilot recognises whether it falls into an Annex IV category, shows the applicable procedure under the Machinery Directive and the Machinery Regulation and guides you through the choice of procedure in the declaration of conformity, including the mandatory notified body details. It does not replace a notified body; it does the groundwork for one.