The document outlines the new EMC Directive (2014/30/EU), detailing its structure, scope changes, and obligations for manufacturers and notified bodies. Key points include updates on conformity assessment procedures, technical documentation requirements, and the process for CE marking and declaration of conformity. Notable changes involve the transition of certain equipment categories to different regulations and the obligation for manufacturers to stay current with harmonized standards.

1. New EMC (2014/30/UE)
Ursula Zanichelli
Milan, 1 April 2016

2. 01.04.2016 NEW EMC DIRECTIVE2
• Scope
• Structure
• A look into the chapters
• Harmonized standards
• Technical documentation
• Declaration of Conformity
Summary

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• Does not apply to custom built evaluation kits destined for
professionals to be used solely at research and
developement facilities
• New RED 2014/53/EU has scope changes affecting EMC
Directive:
 Broadcast receivers move from EMC to RED
 Telecom terminal equipment moves from R&TTE to EMC
 Transmitters operating <9kHz move from EMC to RED
Scope

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• Introductory information
• 6 Chapters, each covering a topic
 General Provisions
 Obligations of Economic Operators  Same as LVD
 Conformity of the Equipment
 Notification of Conformity Assessment Bodies
 Union Market Surveillance, control of electrical Equipment Entering the Union
Market, and Union Safeguard Procedure  Same as LVD
 Committee, Transitional, and Final Provisions  Same as LVD
• Additional 6 informational annexes
Structure

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• Same new definitions as LVD
• Others
 Equipment
 Apparatus
 Fixed installation
 Electromagnetic compatibility
 Electromagnetic disturbance
 Immunity
 Safety purposes
 Electromagnetic environment
Chapter 1 - New definitions

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• No substantial changes compared to 2004/108/EC (for
manufacturers)
• Conformity Assessment Procedure: two options
Module A “Internal production control”
Module B “EU type examination” +
Module C “Conformity of type based on internal
production control”
Chapter 3 - Conformity

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Chapter 3 - Conformity

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• EMC assessment and technical documentation
(e.g. Harmonized standards)
• Manufacturing process and monitoring
• CE marking
• Declaration of Conformity
Annex II Module A – Internal production control

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EU-type examination (NB)
Manufacturer’s application
(Technical documentation)
Technical documentation
analisys from NB
Annex III Module B + Module C
Internal production control
(Manufacturer)
Manufacturing process and
monitoring
CE marking
Declaration of Conformity

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Chapter 4 – Notification
• New obligations: renotification required
• Notified body is a conformity assessment body
• Manufacturer selects a single Notified Body listed in
NANDO database
• No Notified Body number required for CE marking (no
involvement in production control), but name and number
required on Declaration of Conformity

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• NB monitors conformity
 Changes to state of art (i.e.harmonized standards)
 Manufacturer informs NB of product modifications
 NB asks manufacturer for corrective actions if product becomes non-conforming,
otherwise suspends or withdraws certificate
• NB informs Notifying Authority of:
 Certificates issued or withdrawn
 Refusal, restriction, suspension or withdrawal of certificates
 Changes to their notified scope or status
 Subcontracting (on request)
 Request for information by Market Surveillance Authorities
• NB informs other Notified Bodies of:
 Refusal, restriction, suspension or withdrawal of a certificate and, on request, positive
assessments and additions
Chapter 4 - Notified Body duties

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• Annex I - Essential requirements: unchanged
• Annex II - Internal production control: small changes
• Annex III -Module B, Module C: similar to old Annex III, but more
detailed
• Annex IV - EU declaration of conformity: changed
• Annex VI - Correlation Table Correlates between 2004 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
• Where applicable, the notified body’s name and number and intervention
• Additional information:
Aigned for and on behalf of:
(place and date of issue):
(name, function) (signature):
EU declaration - NEW

17. nemko.com/it
Grazie!