the red directive - nemko directive 25.01.… · r&tte implementation since 13th june 2017 all...
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The RED Directive
Roy Uggerud, Nemko Norway
25th January 2018
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R & TTE
Implementation
Since 13th June 2017
all equipment in the scope of
RED must meet the requirements
of 2014/53/EU.
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EU + EEA-EFTA States
• Liechtenstein
• Iceland
• Norway
• Switzerland
Also valid in
• Turkey
Where does RED apply?
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Scope of RED
Products that intentionally emit and/or receive radio
waves for the purpose of Radio Communication or
Radio Determination
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Radio Communication
Radio communication means communcation by means of radio waves
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Radio Determination
Radio determination means determination of the position,
velocity and/or other characteristics of an object.
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Change in scope from R&TTE to RED
R&TTE frequency range:
9 kHz- 3000 GHz
RED frequency range:
0 - 3000 GHz
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Broadcast Radio and TV receivers
(moved from EMCD to RED)
New products in RED
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Railway applications
Robotic lawnmowers
Animal fences
New products in RED < 9 kHz (moved from EMC to RED)
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Metal detectors
Stud finders
T-Coils
New products in RED < 9 kHz (moved from EMC to RED)
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Fixed line terminal equipment (Moved from R&TTE to EMC)
Radio amateur equipment
Military equipment
RED does not cover
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Maritime equipment (Wheelmark)
Airborne equipment
Custom build evaluation kits
RED does not cover
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Article 3.1(a): Health and Safety to persons
RED essential requirements
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Article 3.1(a): Health and SafetyCovers also some categories of animals
RED essential requirements, cont.
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Article 3.1b: EMC (Electromagnetic
compatibility)
RED essential requirements, cont.
➢ Emissions
➢ Immunity
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Article 3.2: Radio Spectrum
RED essential requirements, cont.
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RED essential requirements, cont.
17
Radio equipment falling under the scope of the RED are
excluded from both the Low Voltage Directive (LVD) and
Electromagnetic Compatibility Directive (EMCD):
Therefore the LVD and EMCD do not apply. However the
RED refers to the essential requirements of the LVD and
EMCD.
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Economic operators
MANUFACTURER (Art.10)
AUTHORIZED REPRESENTATIVE
(Art.11)
IMPORTER (Art.12)
DISTRIBUTOR (Art.13)
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Conformity Assessment procedure RED
Conformity assessment procedures - RED
Using harmonized standards
Module A
Internal Production Control
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Conformity assessment procedures - RED
Using harmonized standards
Module B
EU-Type Examination
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0470
Using harmonized standards
Module H
Full Quality Assurance
Conformity assessment procedures - RED
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Conformity Assessment procedure RED
Conformity assessment procedures - RED
Not using or partial use of harmonised standards
Module A
Internal Production Control
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Module B
EU-Type Examination
Not using or partial use of harmonised standards
Conformity assessment procedures - RED
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Conformity assessment procedures - RED
0470
Module H
Full Quality Assurance
Not using or partial use of harmonised standards
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Conformity assessment
• Manufacturer prepares TCF
• Manufacturer prepares DoC
• Manufacturer applies CE marking
• Manufacturer monitors and controls production
Module A
Internal Production
Control
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Conformity assessment
• Manufacturer prepares TCF
• Manufacturer engages NB
• Notified Body issues EU-type Examination certificate
• Manufacturer prepares DoC, applies CE marking, and control production
Modules B and C
EU-Type Examination and Internal Product
Control
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Conformity assessment
• Manufacturer operates an approved QMS
• Notified Body assesses QMS and initiates continuing surveillance
• Manufacturer prepares DoC and applies CE marking
Module H
Conformity based on Full
Quality Assurance
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• A general description of the product
• Drawings, diagrams, BOM
• Test reports• Radio spectrum
• EMC
• Health and safety
• Copy of the Risk Assessment document
• Copy of the manufacturer’s declaration
Technical Construction File (TCF)
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Marking
Manufacturer’s Trade Name/MarkFull postal address and contact of manufacturer
Product name/Model:
Batch/Serial No.:
Importer name
Full postal address and contact details of importer
0470 Only use NB no. if Full
Quality Assurance is used
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Marking when there are restrictions of use
On packaging
ES LU RO
CZ FR HU
SI DK HR
In user documentation
The alert symbol is no longer required!!
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Language
Language shall be easily
understood by authorities
Language shall be easily
understood by consumers
and end users
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Notified Body document under R&TTE
Notified
Body
Opinion
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Notified Body document under RED
33
EU-type
Examination
Certificate
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EU-Type Examination Certificate
➢Notified Body & Number
➢Manufacturer’s name & address
➢ Identification of the product
➢Conclusion of the examination
➢Requirements covered by the examination
➢Conditions for validity
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A notified body is an organization designated by an
EU country to assess the conformity of certain
products before being placed on the market.
What is a Notified Body?
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Challenges
• Standards not yet listed as harmonized in OJ, but the
most common ones are now listed.
• Limited amount of harmonized standards in OJ
• 156 standards (15.12.2017)
• Not possible to use Module A due to missing harmonized
standards
• R&TTE standards do not give presumption of conformity
to RED automatically
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• When there are no RED standards available, manufacturers
can use alternative conformity assessment procedures
through a Notified Body for their assessment.
• R&TTE standards
• Draft RED standards
• Other alternative conformity procedures
• When referring to R&TTE standards or draft RED standards
in the EU-Type Examination Certificate, the Commission
has recommended to put an expiry date on the certificate.
Time of urgency, how to act?
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25.01.2018 THE RED DIRECTIVE
Thank you!
38
Nemko AS
Roy Uggerud
TEL: +47 22 96 03 24
EMAIL: [email protected]
/nemko.com