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.