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Regulatory ESSENTIAL
Europ. Economi. - Machine Safety - Product Cat. 2 Partly Completed Machinery

Modular information package with all the essential information for compliant products in your target market.
Conveniently read online at Product-Compliance-Portal ROGER WILLCO.

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Stakeholders:      Manufacturer     
Application: partly completed machinery; declaration of incorporation, risk assessment, technical documentation; Directive 2006/42/EC
Countries: Image for EEA European Economic Area (EU + Iceland, Lichtenstein, Norway),  
#r86u  
Status: Published 2022-01-05 by Torsten Sahm and Michael Loerzer
Last change 2024-05-02 by Ina May: Hints, Machine safety and guarding
   
Price 365 day licence for 430.70 € net         Buy this REGULATORY ESSENTIAL >>

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Subject Areas of this Essential:


Machine safety and guarding

Scope of this ESSENTIAL
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.'

Hints
here you will get a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO licence)

Specific recommendations, information or most common mistakes

Analysis of regulatory requirements

Legislation in force for this PCT
here you will get a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO licence)

Are legal provisions regulates the product compliance topic? If yes, what is the reference (title, number)?

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.
'

Responsible actors
here you will get textual information

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)
here you will get textual information

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)

Exemption clauses
here you will get textual information

Exempted devices/products or industry sectors.

Sub-federal legislation of states/counties
here you will get textual information

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
here you will get textual information

Has the country signed a Free Trade Agreement (FTA) or a Mutual recognition agreement (MRA) with EU?

Authority
here you will get related hyperlink(s)

Name of the authority for approval, registration, market surveillance and/or enforcement

Link/Reference to other reference document(s)
here you will get a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO licence)

Hints
here you will get textual information

Specific recommendations, information or most common mistakes

Hints
here you will get related hyperlink(s)

Specific recommendations, information or most common mistakes

Route to compliance

Formal and administrative requirements

Registration at related authority required?
here you will get textual information

Product registration? Manufacturer registration? Importer / Representative registration? if required.

Local representative legally required?
here you will get textual information

[Yes/No]

Equipment authorization (approval process)

Approval process (conformity assessment procedure)
here you will get textual information

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
here you will get textual information

e. g. SDoC, technical documentation (for 10 years), filled-in approval forms (e. g. ACMA in AUT)

Conformance document validity and renewal
here you will get textual information

Validity for Conformance document name mentioned. For mandatory certification validity is important.

Which documents are required by an approval body?
here you will get textual information

e .g. formal application

Is a factory inspection legally required
here you will get textual information

Testing & Standards

Specific requirements for testing
here you will get textual information

e. g. is an accredited test lab. mandatory, limits, test samples, product description

General information to the application of standards
here you will get textual information

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?
here you will get textual information

Source for standards for conformity assessment
here you will get related hyperlink(s)

Acceptance of foreign test reports
here you will get textual information

Regulatory labelling, markings and user information

Regulatory label (mandatory)
here you will get textual information

e. g. product label

Required information on the product and/or packaging
here you will get textual information

e. g. address of the manufacturer/importer, serial number

User instructions language(s)
here you will get textual information

Regulated by the legal provisions

User instruction requirements and specific compliance notes
here you will get textual information

Form, sentence inside, simple text. E. g. FCC/ISED compliance information, SAR information, battery, environmental information like waste

Warnings, symbols
here you will get textual information

e. g. ANSI Z 535.4

General Information:

   European Economic Area (EU + Iceland, Lichtenstein, Norway)

Code, ContinentEEA,
Economic Area
Official Language24 official languages
Standard Institute
HS Codemember

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