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.

Scales; automatic weighing instruments; non automatic weighing instruments; Measuring Instruments; Type approval; Pattern approval; legal metrology, metrology mark; WELMEC; OIML; gravity zone; verification
Scope: This ESSENTIAL describes the regulatory requirements for automatic weighing instruments (AWI) as defined in in Article 2 of 2014/32/EU, category MI-006.

Stakeholders: Manufacturer, Importer
Legislation in force: Article 2. Scope (of 2014/32/EU) 1. This Directive applies to the measuring instruments defined in the instrument-specific Annexes III to XII (hereinafter ‘instrument-specific Annexes’) concerning: - MI-001 water meters - MI-002 gas meters and volume conversion devices - MI-003 active electrical energy meters - MI-004 thermal energy meters - MI-005 measuring systems for continuous and dynamic measurement of quantities of liquids other than water - MI-006 automatic weighing instruments - MI-007 taximeters - MI-008 material measures - MI-009 dimensional measuring instruments - MI-010 exhaust gas analysers

Application national: European Economic Area, Automatic weighing instruments, Catchweigher, Checkweigher, (MI-006)

Countries: Image for EEA European Economic Area (EU + Iceland, Lichtenstein, Norway),  
Status: Published 2023-01-26 by Anette Dunkel-Reinboth and Michael Loerzer
Last change 2023-09-25 by Anette Dunkel-Reinboth: Scope of this ESSENTIAL, Metrology and legal metrology
ROGER WILLCO ID: #y66y
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Scope of this ESSENTIAL
This ESSENTIAL describes the regulatory requirements for automatic weighing instruments (AWI) as defined in in Article 2 of 2014/32/EU, category MI-006.'

Analysis of regulatory requirements

Measuring Device Type
Here you will get textual information

e. g. NAWI, AWI

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)?

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 related hyperlink(s)

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.

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 related hyperlink(s)

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]

Member of International Metrology Organizations
Here you will get textual information

e.g. OIML

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

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

Hints
Here you will get textual information

Specific recommendations, information or most common mistakes

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)

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

Acceptance of foreign test reports
Here you will get textual information

Country gravity zones
Here you will get related hyperlink(s)

Verification Regulation
Here you will get related hyperlink(s)

DE: Eichwesen

Regulatory labelling, markings and user information

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

e. g. product label

Specific Metrology Marking(s)
Here you will get a image or chart

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


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






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