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CE Marking, Radio & Medical Updates
CE Marking has changed –what do you need to know?Steve HayesGeneral Manager
CE Marking – basically the same but different
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’
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
• 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.
EMC
Conducted
Radiated
ATEX
Machinery Directive
Radio Equipment Directive
Measuring Instrument Directive
Medical Directive
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
Steps to Compliance
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
Risk
Why has ‘risk’ been introduced into CE Marking?
Types of Risk
Risk of product
non-compliance
Design/Production
Risk assessmentDesign phase
Product presenting
a riskMarket surveillance/
enforcement
Hierarchy in EU terminology
Getting to the CE Mark
Certification
Technical Files
Testing + Test Reports
Test Plans
Compliance Strategies
Ris
k
Directives have changed – Why? - the NLF objectives
The CE Mark
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
Radio Equipment Directive – odd one out?
The remaining directives
The details
When does CE Marking apply?
Actors in the supply chain
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
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
Standards
BSDIN/VDE
IECISO
EN
Production
Technical Documentation
Risk analysis
Drawings
Descriptions
Standards used (or other
technical specifications)
similarities
Test reports Design calculationsDoC
NB Type Cert
EU Declaration of Conformity
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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