Anwendungsbereich des Regulatory Essentials
This CRF describes the regulatory requirements of the EU Machinery Directive 2006/42/EC (MD) with all related amendments for the product category 1 (Complete Machinery) and the legal obligations for manufacturers.
For uncompleted machinery the "ESS EEA Machine Safety - Product Cat. 2" is applicable. For the purposes of the MD, machinery (product category 1) designates the products listed in Article 1 section 1 (a) to (f).
Manufacturer, Importer, B2C products, B2B products
Geltende Rechtsvorschriften:
The applicable hamonization legislation is the so-called Machinery Directive (MD) 2006/42/EC which is mandatory since 2009-12-29.
The last consolidated version is from 2019 and can be found with the link.
Machinery Directive (MD) is valid until 19 January 2027.
Successor: Machinery Regulation (EU) 2023/1230 (MR) valid from 20 January 2027.
No transition time.
Nationale Anwendungsebene:
machinery, interchangeable equipment, safety components, lifting accessories, chains ropes and webbing, removable mechanical transmission devices, CE marking, legal obligations, conformity assessment, declaration of conformity, technical documentaion, risk assessment, placing on the market, putting into service; Directive 2006/42/EC
European Economic Area (EU + Iceland, Lichtenstein, Norway)
Kommentar bezüglich der Vergleichbarkeit mit der EU-Gesetzgebung:
Published 2022-01-05 by Manfred Böhm and Torsten Sahm
Last change 2025-07-29 by Manfred Böhm: Market surveillance authority, Machine safety and guarding
Inhalt des Regulatory Essentials
| Legislation in force for this PCT |
Hier finden Sie ein thematisch passendes Dokument in ATERIOS
(Zugang nur mit erweiterter ATERIOS Lizenz)
Are legal provisions regulates the product compliance topic? If yes, what is the reference (title, number)?
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| Scope of legislation |
The Directive applies to the following products (article 1 section 1):
(a) machinery
(b) interchangeable equipment
(c) safety components
(d) lifting accessories
(e) chains ropes and webbing
(f) removable mechanical transmission devices and
(g) partly completed machinery.
'
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| Responsible actors |
Hier erhalten Sie textbasierte Informationen
Which actor(s) are responsible for compliance with the legal provisions: e. g.
- economic operators (manufacturer, importer, distributor, fulfilment service provider),
- user (commercial/industrial/professional),
- user (private, consumer)?
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| Regulatory market access conditions for the actor(s) |
Hier erhalten Sie textbasierte Informationen
What are the main regulatory requirements (e. g. conformity assessment fulfilment of essential requirements of Annex I 2006/42/EC) prior placing on the market, importation and putting into service (brief description)
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| Penalty by this legislation |
Hier erhalten Sie textbasierte Informationen
What are the possible penalties (e. g. sales ban, fines) in the case of non-compliance?
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| Exemption clauses |
Hier erhalten Sie textbasierte Informationen
Exempted devices/products or industry sectors.
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| Sub-federal legislation of states/counties |
Hier erhalten Sie textbasierte Informationen
E. g. by 2019 an Inter-Governmental Agreement (IGA) on governance of the Electrical Equipment Safety System (EESS) has been signed by Queensland, Victoria, Western Australia and Tasmania.
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| FTA/MRA status with EU |
Hier erhalten Sie textbasierte Informationen
Has the country signed a Free Trade Agreement (FTA) or a Mutual recognition agreement (MRA) with EU?
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| Authority |
Hier erhalten Sie textbasierte Informationen
Name of the authority for approval, registration, market surveillance and/or enforcement
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| Market surveillance authority |
Hier erhalten Sie zugehörige weiterführende Links
Name of the authority for market surveillance and/or enforcement
|
| Link/Reference to other reference document(s) |
Hier finden Sie ein thematisch passendes Dokument in ATERIOS
(Zugang nur mit erweiterter ATERIOS Lizenz)
|
| Link/Reference to other reference document(s) |
Hier finden Sie ein thematisch passendes Dokument in ATERIOS
(Zugang nur mit erweiterter ATERIOS Lizenz)
|
| Comment on the comparability to EU legislation |
Hier erhalten Sie textbasierte Informationen
|
| Hints |
Hier erhalten Sie zugehörige weiterführende Links
Specific recommendations, information or most common mistakes
|
Formal and administrative requirements
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| Registration at related authority required? |
Hier erhalten Sie textbasierte Informationen
Product registration?
Manufacturer registration?
Importer / Representative registration?
if required.
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| Local representative legally required? |
Hier erhalten Sie textbasierte Informationen
[Yes/No]
|
Equipment authorization (approval process)
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| Approval process (conformity assessment procedure) |
Hier erhalten Sie ein Foto oder Diagram
Means each legally required approval process prior placing on the market, importation or putting into service
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| Conformance document(s) to show compliance to the authority |
Hier erhalten Sie textbasierte Informationen
e. g. SDoC, technical documentation (for 10 years), filled-in approval forms (e. g. ACMA in AUT)
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| Conformance document validity and renewal |
Hier erhalten Sie textbasierte Informationen
Validity for Conformance document name mentioned. For mandatory certification validity is important.
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| Which documents are required by an approval body? |
Hier erhalten Sie textbasierte Informationen
e .g. formal application
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| Is a factory inspection legally required |
Hier erhalten Sie textbasierte Informationen
|
| Hint to voluntary certification scheme |
Hier erhalten Sie textbasierte Informationen
If a important voluntary certification schemes exists, one link will be given.
Important voluntary schemes are for example: UL, CSA, VCCI (Japan)
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| Specific requirements for testing |
Hier erhalten Sie textbasierte Informationen
e. g. is an accredited test lab. mandatory, limits, test samples, product description
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| General information to the application of standards |
Hier erhalten Sie textbasierte Informationen
e. g. China: GB standards are mandatory, EU: harmonized standards shall be published in the OJEU with respect to "presumption of conformity"
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| Is in-country testing legally required? |
Hier erhalten Sie textbasierte Informationen
|
| Source for standards for conformity assessment |
Hier erhalten Sie zugehörige weiterführende Links
|
| National Standardisation Organisation |
Hier erhalten Sie zugehörige weiterführende Links
Link to organisation
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| Are national standards based on IEC/ISO standards? |
Hier erhalten Sie textbasierte Informationen
Undetailed information
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| Acceptance of foreign test reports |
Hier erhalten Sie textbasierte Informationen
|
| Hints |
Hier erhalten Sie zugehörige weiterführende Links
Specific recommendations, information or most common mistakes
|
Regulatory labelling, markings and user information
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| Regulatory label (mandatory) |
Hier erhalten Sie ein Foto oder Diagram
e. g. product label
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| Required information on the product and/or packaging |
Hier erhalten Sie textbasierte Informationen
e. g. address of the manufacturer/importer, serial number
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| User instruction requirements and specific compliance notes |
Hier erhalten Sie textbasierte Informationen
Form, sentence inside, simple text.
E. g. FCC/ISED compliance information, SAR information, battery, environmental information like waste
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| Digital user documentation allowed? |
Hier erhalten Sie textbasierte Informationen
User instructions allowed by QR-Code/internet or digital medium or integrated in device with display?
Safety instruction allowed by QR-Code or digital medium?
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| Warnings, symbols |
Hier erhalten Sie textbasierte Informationen
e. g. ANSI Z 535.4
|
| User instructions language(s) |
Hier erhalten sie eine Tabelle
Regulated by the legal provisions
|
| Hints |
Hier erhalten Sie textbasierte Informationen
Specific recommendations, information or most common mistakes
|
Allgemeine Informationen
European Economic Area (EU + Iceland, Lichtenstein, Norway)
Code, Kontinent, Wirtschaftsraum
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