Anwendungsbereich des Regulatory Essentials
This ESSENTIAL describes the regulatory requirements
of the EU Machinery Directive 2006/42/EC (MD) with all related amendments (2020)
for PARTLY COMPLETED MACHINERY (product category 2) and the legal obligations for manufacturers.
For machinery the "ESS EEA Machine Safety - Product Cat. 1" is applicable.
Manufacturer, Importer, B2C products, B2B products
Geltende Rechtsvorschriften:
The applicable hamonisation legislation is the so-called Machinery Directive (MD) 2006/42/EC which is mandatory since 2009-12-29.
Nationale Anwendungsebene:
partly completed machinery; declaration of incorporation, risk assessment, technical documentation; 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 Benjamin Kerger
Last change 2025-07-29 by Manfred Böhm: Market surveillance authority, Machine safety and guarding
Inhalt des Regulatory Essentials
| Scope of legislation |
This 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)?
|
| 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)
|
| 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?
|
| Exemption clauses |
Hier erhalten Sie textbasierte Informationen
Exempted devices/products or industry sectors.
|
| 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.
|
| 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?
|
| Authority |
Hier erhalten Sie textbasierte Informationen
Name of the authority for approval, registration, market surveillance and/or enforcement
|
| 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)
|
| Comment on the comparability to EU legislation |
Hier erhalten Sie textbasierte Informationen
|
| Hints |
Hier erhalten Sie textbasierte Informationen
Specific recommendations, information or most common mistakes
|
| 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.
|
| Local representative legally required? |
Hier erhalten Sie textbasierte Informationen
[Yes/No]
|
Equipment authorization (approval process)
|
| Approval process (conformity assessment procedure) |
Hier erhalten Sie textbasierte Informationen
Means each legally required approval process prior placing on the market, importation or putting into service
|
| 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)
|
| Conformance document validity and renewal |
Hier erhalten Sie textbasierte Informationen
Validity for Conformance document name mentioned. For mandatory certification validity is important.
|
| Which documents are required by an approval body? |
Hier erhalten Sie textbasierte Informationen
e .g. formal application
|
| 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)
|
| Specific requirements for testing |
Hier erhalten Sie textbasierte Informationen
e. g. is an accredited test lab. mandatory, limits, test samples, product description
|
| 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"
|
| 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
|
| Are national standards based on IEC/ISO standards? |
Hier erhalten Sie textbasierte Informationen
Undetailed information
|
| Acceptance of foreign test reports |
Hier erhalten Sie textbasierte Informationen
|
Regulatory labelling, markings and user information
|
| Regulatory label (mandatory) |
Hier erhalten Sie textbasierte Informationen
e. g. product label
|
| Regulatory e-labelling allowed? |
Hier erhalten Sie textbasierte Informationen
e. g. put the regulatory information and labels in a software menu
|
| Required information on the product and/or packaging |
Hier erhalten Sie textbasierte Informationen
e. g. address of the manufacturer/importer, serial number
|
| 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
|
| 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?
|
| 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
|
Allgemeine Informationen
European Economic Area (EU + Iceland, Lichtenstein, Norway)
Code, Kontinent, Wirtschaftsraum
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