Regulatory ESSENTIAL



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

Apparatus; EMC; electromagnetic compatibility; fixed installation; Electrical equipment; Electronic; Electronic equipment; Electronical appliance

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Scope: This ESSENTIAL describes the regulatory requirements for the electromagnetic compatibility for devices according general EMC directive 2014/30/EU. (CE marking) Emission and immunity requirements are given. Special areas like automotive, ships and trains are not part of this legislation and this ESSENTIAL.

Stakeholders: Manufacturer, Importer
Legislation in force: The applicable hamonization legislation is the so-called Electromagnetic Compatibility Directive (EMC) 2014/30/EU which is mandatory since 20 April 2016 (Text with EEA relevance).

Application national: apparatus

Countries: Image for EEA European Economic Area (EU + Iceland, Lichtenstein, Norway),  
Comment on the comparability to EU legislation: Not applicable....
Status: Published 2020-03-29 by Torsten Sahm and Michael Loerzer
Last change 2024-11-11 by Ina May: Source for standards for conformity assessment, Electromagnetic Compatibility (EMC) - Devices
ROGER WILLCO ID: #r86w
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Scope of this ESSENTIAL
This ESSENTIAL describes the regulatory requirements for the electromagnetic compatibility for devices according general EMC directive 2014/30/EU. (CE marking)
Emission and immunity requirements are given.
Special areas like automotive, ships and trains are not part of this legislation and this ESSENTIAL.
'

Abbreviations
Here you will get textual information

Important abbreviations which are special for this legislation or theme.

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 license)

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

Hints
Here you will get related hyperlink(s)

Specific recommendations, information or most common mistakes

Scope of legislation
This ESSENTIAL describes the regulatory requirements for the apparatus as defined in Article 3 and the legal obligations for manufacturers.

Article 2:
1. This Directive shall apply to equipment as defined in Article 3.

Article 3:
1. For the purposes of this Directive, the following definitions shall apply:
(1) ‘equipment’ means any apparatus or fixed installation;
(2) ‘apparatus’ means any finished appliance or combination thereof made available on the market as a single functional unit, intended for the end-user and liable to generate electromagnetic disturbance, or the performance of which is liable to be affected by such disturbance;

2. For the purposes of this Directive, the following shall be considered as apparatus:
(1) ‘components’ or ‘sub-assemblies’ intended for incorporation into an apparatus by the end-user, which are liable to generate electromagnetic disturbance, or the performance of which is liable to be affected by such disturbance;
(2) ‘mobile installations’ defined as a combination of apparatus and, where applicable, other devices, intended to be moved and operated in a range of locations.'

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)?

Responsible actors
Here you will get a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO license)

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)

Penalty by this legislation
Here you will get textual information

What are the possible penalties (e. g. sales ban, fines) in the case of non-compliance?

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 textual information

Name of the authority for approval and/or registration

Market surveillance authority
Here you will get related hyperlink(s)

Name of the authority for 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 license)

Comment on the comparability to EU legislation
Here you will get textual information

Hints
Here you will get textual information

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]

Hints
Here you will get textual information

Specific recommendations, information or most common mistakes

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

Approval process (conformity assessment procedure)
Here you will get a image or chart

Means each legally required approval process prior placing on the market, importation or putting into service

Is the IECEE CB Scheme accepted by the authority/approval body?
Here you will get textual information

"[Yes/ No / no information available] [Text] Information (website)"

Conformance document(s) to show compliance to the authority
Here you will get linked document(s)

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

Hints
Here you will get textual information

Specific recommendations, information or most common mistakes

Hint to voluntary certification scheme
Here you will get textual information

If a important voluntary certification schemes exists, one link will be given. Important voluntary schemes are for example: UL, CSA, VCCI (Japan)

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"

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

National Standardisation Organisation
Here you will get related hyperlink(s)

Link to organisation

Are national standards based on IEC/ISO standards?
Here you will get textual information

Undetailed information

Is in-country testing legally required?
Here you will get textual information

Acceptance of foreign test reports
Here you will get textual information

Hints
Here you will get textual information

Specific recommendations, information or most common mistakes

Regulatory labelling, markings and user information

Regulatory label (mandatory)
Here you will get a image or chart

e. g. product label

Regulatory label (mandatory)
Here you will get a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO license)

e. g. product label

Regulatory e-labelling allowed?
Here you will get textual information

e. g. put the regulatory information and labels in a software menu

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 a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO license)

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

Digital user documentation allowed?
Here you will get textual information

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
Here you will get textual information

e. g. ANSI Z 535.4

Hints
Here you will get textual information

Specific recommendations, information or most common mistakes


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






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