New EMC (2014/30/UE)Ursula Zanichelli

Milan, 1 April 2016

01.04.2016 NEW EMC DIRECTIVE2

• Scope• Structure• A look into the chapters• Harmonized standards• Technical documentation• Declaration of Conformity

Summary

01.04.2016 NEW EMC DIRECTIVE3

• 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 internalproduction 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 documentationanalisys 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 numberrequired 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

nemko.com/it

Grazie!