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CE Marking, Radio & Medical Updates
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CE Marking has changed –what do you need to know?Steve HayesGeneral Manager
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CE Marking – basically the same but different
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Why do we have CE Marking?
• Health, Safety and Environmental Protection
• Single, harmonised set of technical requirements
• Free movement of goods and services – ‘level playing field’
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New directive numbers
Directive Scope
2014/28/EU Explosives for civil uses
2014/29/EU Simple pressure vessels
2004/108/EC 2014/30/EU Electromagnetic compatibility
2014/31/EU Non-automatic weighing instruments
2004/22/EC 2014/32/EU Measuring instruments
2014/33/EU Lifts
94/9/EC 2014/34/EU Equipment and protective systems intended for use in potentially explosive atmospheres
2006/95/EC 2014/35/EU Electrical equipment designed for use within certain voltage limits
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• Electric shock hazards
• Mechanical hazards
• Energy hazards
• Chemical hazards
• Radiation hazards
• Fire hazards
The Low Voltage Directive (LVD)
The Low Voltage Directive (LVD) applies to all electrical equipment designed for incorporation into other equipment or use in its own right with a voltage rating of between 50 and 1000V ac and 75 and 1500V dc.
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EMC
Conducted
Radiated
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ATEX
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Machinery Directive
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Radio Equipment Directive
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Measuring Instrument Directive
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Medical Directive
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The European Union (The EU)
28Countrie
s
5Candidat
e Countrie
s
15Non-EU Countrie
s
27Countrie
s
5Candidat
e Countrie
s
16Non-EU Countrie
s
Now Post-Brexit
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Steps to Compliance
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What's in a CE Marking directive?
Essential Requirements
Risk Analysis Evidence
• Technical Documentation
• DofC• NB Type Cert
Testing
Technical Rationale
Whereas: background/objectives
Annexes
Directive
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Risk
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Why has ‘risk’ been introduced into CE Marking?
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Types of Risk
Risk of product
non-compliance
Design/Production
Risk assessmentDesign phase
Product presenting
a riskMarket surveillance/
enforcement
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Hierarchy in EU terminology
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Getting to the CE Mark
Certification
Technical Files
Testing + Test Reports
Test Plans
Compliance Strategies
Ris
k
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Directives have changed – Why? - the NLF objectives
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The CE Mark
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Change of scope
EMCD – 2014/30/EULVD – 2014/35/EU
RED – 2014/53/EU
Wirelinetelecommunication
equipment
Broadcast receivers
EMCD – 2004/108/ECLVD – 2006/95/EC
R&TTED – 1999/5/EC
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Radio Equipment Directive – odd one out?
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The remaining directives
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The details
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When does CE Marking apply?
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Actors in the supply chain
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Complying with the EMCD
EMC assessment or
Application of HS
D.o.CTechnical
documentation
Optional Type Examination from
notified bodyProduct type
Application of ‘general
requirements’
Apparatus
Installation
Name of:manufacturer
importer
Type: xxx-yyyS/N: 123456
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Complying with the LVD
Application of harmonised
standard
D.o.CTechnical
documentation
Electrical equipment
Name of:manufacturer
importer
Type: xxx-yyyS/N: 123456
Notified Body no longer applies
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Standards
BSDIN/VDE
IECISO
EN
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Production
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Technical Documentation
Risk analysis
Drawings
Descriptions
Standards used (or other
technical specifications)
similarities
Test reports Design calculationsDoC
NB Type Cert
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EU Declaration of Conformity
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Conclusions
• If you haven’t reviewed your compliance against the new requirements, do so now!
• If you are involved in wireless/radio products – Listen to Simon’s talk!
• If you don’t know what you need to do – contact to us now!
• If you need help with any of the above or don’t have the resources available, we can help.
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