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New LVD (2014/35/UE)
Ursula Zanichelli
Milan, 1 April 2016
01.04.2016 NEW LVD2
• Purposes of the change
• Scope and structure
• Major changes
• A look into the chapters
• Harmonized standards
• Technical documentation
• Declaration of Conformity
Summary
01.04.2016 NEW LVD3
• 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
01.04.2016 NEW LVD4
• 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
01.04.2016 NEW LVD5
• 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
01.04.2016 NEW LVD6
• 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
01.04.2016 NEW LVD7
• 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
01.04.2016 NEW LVD8
• 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?
01.04.2016 NEW LVD9
• 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
01.04.2016 NEW LVD10
• 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
01.04.2016 NEW LVD11
• 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
01.04.2016 NEW LVD12
• 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
01.04.2016 NEW LVD13
• 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
01.04.2016 NEW LVD14
• 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
01.04.2016 NEW LVD15
• 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
01.04.2016 NEW LVD16
• 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
01.04.2016 NEW LVD17
• No substantial changes, only risk assessment
Technical documentation
01.04.2016 NEW LVD18
• 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
01.04.2016 NEW LVD19
• 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
nemko.com/it
Grazie!

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New LVD directive (2014/35/UE)

  • 1. New LVD (2014/35/UE) Ursula Zanichelli Milan, 1 April 2016
  • 2. 01.04.2016 NEW LVD2 • Purposes of the change • Scope and structure • Major changes • A look into the chapters • Harmonized standards • Technical documentation • Declaration of Conformity Summary
  • 3. 01.04.2016 NEW LVD3 • 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
  • 4. 01.04.2016 NEW LVD4 • 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
  • 5. 01.04.2016 NEW LVD5 • 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
  • 6. 01.04.2016 NEW LVD6 • 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
  • 7. 01.04.2016 NEW LVD7 • 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
  • 8. 01.04.2016 NEW LVD8 • 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?
  • 9. 01.04.2016 NEW LVD9 • 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
  • 10. 01.04.2016 NEW LVD10 • 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
  • 11. 01.04.2016 NEW LVD11 • 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
  • 12. 01.04.2016 NEW LVD12 • 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
  • 13. 01.04.2016 NEW LVD13 • 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
  • 14. 01.04.2016 NEW LVD14 • 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
  • 15. 01.04.2016 NEW LVD15 • 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
  • 16. 01.04.2016 NEW LVD16 • 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
  • 17. 01.04.2016 NEW LVD17 • No substantial changes, only risk assessment Technical documentation
  • 18. 01.04.2016 NEW LVD18 • 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
  • 19. 01.04.2016 NEW LVD19 • 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