New LVD (2014/35/UE)Ursula Zanichelli

Milan, 1 April 2016

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• Purposes of the change• Scope and structure• Major changes• A look into the chapters• Harmonized standards• Technical documentation• Declaration of Conformity

Summary

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• Clarify the definitions and obligations of economic operators on the EU market • Especially for the manufacturer and

importer. • Manufacturer has the sole duty of

conformity assessment of the product.

• Use of a more comprehensive measure to trace the product supply chain • Both manufacturers and importers

shall be identified easily.

• Enhance the market surveillance activity to prohibit a non-compliant product or a product which presents a risk.

Purposes of the change

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• The Low Voltage Directive covers electrical equipment with a voltage between 50 and 1000 V for alternating current and between 75 and 1500 V for direct current.

• Applies to equipment when placed on the market : new electrical equipment made by a manufacturer established in the Union or Electrical equipment, whether new or second-hand, imported from a third country

• Voltage ratings refer to the voltage of the electrical input or output, not to voltages that may appear inside the equipment.

• For most electrical equipment, the health aspects of emissions of Electromagnetic Fields are also under the domain of the Low Voltage Directive.

Scope and structure

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• Introductory information

• 5 Chapters, each covering a topic General Provisions Obligations of Economic Operators Conformity of the Electrical Equipment Union Market Surveillance, control of electrical Equipment Entering the Union

Market, and Union Safeguard Procedure Committee, Transitional, and Final Provisions

• Additional 6 informational annexes

Scope and structure

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• Scope Change: The LVD now includes protection of health of people, animals and property. It covers mechanical or chemical risks in addition to the electrical risks. Risk assessment and analysis is a major part of the change.

• Market Surveillance has now been added to ensure stricter compliance

• Responsibility for preparation of CE marking documentation, and the EU declaration of Conformity (DoC) now relies solely on the manufacturer.

• There is no conformity assessment procedure in this Directive which requires the intervention of a notified body.

• Technical docs and EU declaration to be kept for 10 years

Major changes

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• Defines each economic operator Manufacturer Authorized representative Importer Distributor

• Activities Making available on the market Placing on the market Conformity assessment Withdrawal Recall

• CE Marking By which the manufacturer indicates that the equipment is in conformity

Chapter 1 - New definitions

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• Any economic operator Who places the equipment on the market under his own trade name or trade

mark or Who modifies the equipment where compliance may be impacted

• Manufacturer is responsible for the compliance and to issue the EU DoC

Who is the manufacturer?

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• Manufacturers Requirements for series production (to remain in conformity) Register of complaints Register of non-conforming equipment and recalls Inform distributors

• Technical documentation kept for 10 years by each responsible operator

Chapter 2 – Obligations of Economic Operators

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• Articles 6 – 11 - Extended obligations for manufacturers, representatives, importers and distributors to improve traceability of products:

Type, batch or serial number or other element of identification Name, registered trade name or trade mark and postal address of

manufacturer For imports, name, registered trade name or trade mark and postal

address of importer Note that (8), encourages the use of a website address in addition to

a postal address

Chapter 2 – Obligations of Economic Operators

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• Specified requirements on the conformity assessment procedure

First, apply the harmonized standards which have been published in the OJ

In case of absence of harmonized standards, safety requirements of IEC standards

If for the product no IEC standards are available, application of suitable national standards

Chapter 3 - Conformity

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• Articles 16 & 17 Removed the requirement of support from notified body

No conformity assessment procedure requires the intervention of a Notified Body

• EU DoC shall be translated into each Member State language where the equipment is placed on the market

Chapter 3 - Conformity

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• More detailed requirement of market surveillance

• Exchange of information on non-conforming product among Member states

• Compliant equipment which still presents a risk to the health or safety persons, or to domestic animals, or to property must be made to prevent that risk

Chapter 4 – Market surveillance

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• Committee Procedure Establishes a Committee on Electrical Equipment • Penalties Defers to Member States • Transition Allows current Directive to be used until April 20, 2016 • Repeal Directive 2006/95/EC repealed on April 20, 2016 • Entry into force 20 days after publishing

Chapter 5 - Provisions

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• Annex I - Resistant to non-mechanical influences to avoid endangering persons, domestic animals, and property

• Annex II - Equipment outside of the scope : custom built evaluation kits destined for professionals to be used solely at research and development facilities for such purposes are now exempt from the Low Voltage Directive

• Annex III - Additional requirements for preparation of technical documentation for “adequate analysis and assessment of the risk(s)”

• Annex IV – Title, number of the declaration (optional), identification of the product for traceability, no need for the year of the CE marking, new directive number

• Annex VI - Correlation Table Correlates between 2006 and 2014 Directives

Annexes

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• The EN harmonized standards in the Official Journal don’t change as a result of the recast directive, so the technical requirements used previously will remain the same going forward.  However, all harmonized standards are regularly updated as they evolve to adapt to new technology.  It’s the manufacturer’s obligation to review the Official Journal on a regular basis and ensure their products remain compliant with the most current revision of the harmonized standards.

Harmonized Standards

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• No substantial changes, only risk assessment

Technical documentation

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• Name and address of the manufacturer or his representative

• Description of the equipment• Reference to harmonized standards• Reference to the specifications with which conformity is

declared (when necessary)• Identification of the signatory (manufacturer or authorized

representative)• Last two digits of the year of CE marking

EC declaration - OLD

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• EU DECLARATION OF CONFORMITY (No xxxx *optional*)• Model/product type, batch or serial number• Name and address of manufacturer or representative• «This declaration of conformity is issued under the sole responsibility

of the manufacturer»• Object of the declaration (i.e. Coloured image)• «The object of the declaration described above is in conformity with

the relevant Union harmonization legislation»• Reference to harmonized standards• Additional information:

Signed for and on behalf of:(place and date of issue):(name, function) (signature):

EU declaration - NEW

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Grazie!