CE marking in European market

1. By: AARTIVATSA
MPHARMA (DRA),2ND SEM
22390805

2. TABLEOF
CONTENT:
 Introduction
 CE Mark
 Classification of Medical Device
 Why CE Marking is required?
 How DoYou Benefit from CE Marking?
 CE Marking Directives.
 Affixation of the MarkingToYour Product.
 HowTo Get Certified?
 Technical Documentation
 Declaration of Conformity

3. Introduction:
 CE Marking is the symbol .The letters "CE" are the abbreviation of
French phrase "Conformité Européene" which literally means
"European Conformity".The term initially used was "EC Mark" and
it was officially replaced by "CE Marking" in the Directive
93/68/EEC in 1993. "CE Marking" is now used in all EU official
documents.
 The Directives outline the safety and performance requirements
for medical devices in the European Union (EU).
 The CE mark is a legal requirement to place a device on the market
in the EU

4. CE MARK:
The CE marking shall consist of the initials ‘CE’ taking the following
form:
 The various components of the CE marking must have substantially
the same vertical dimension, which may not be less than 5mm.

5. Classification
of Medical
Device:
 There are four types of Medical Device in EU:
1. Non-invasive Device
2. Invasive Device
3. Active Device
4. Special Rules

6. WhyCE
marking is
required?
 It is passport for product to enter EUROPE market.
 Implies conformance with all European Directives
 InspectionAuthorities
 Preempts all other marks for same requirements
 Not a quality mark!
 Measurement
 Affixing
 Labeling
 Consumer will consider CE marking On Product as an indication of
conformance to laid down minimum standards.

7. How DoYou
Benefit from
CE Marking?
The CE Marking allows the manufacturer to freely circulate their
product throughout the 30 countries of the European Economic
Area (EMA).
 The great benefit for manufacturers is that there is now only one
set of requirements and procedures to comply with in designing
and manufacturing a product for the entire EEA.
 The various and conflicting national regulations are eliminated.
 As a result, the product no longer needs to be adapted to the
specific requirements of the different member states of the EEA.
 In addition, it may be considered a benefit that by implementing
the requirements, the product will be safer for the user and this
may also reduce damage and liability claims.

8. Other than then legal
requirements to doso,
benefits ofCEmarking
include:
 Products can be compared across borders (harmonized product
and test standards).
 Testing independently undertaken by accredited third party.
 Some of the testing goes beyond traditional national
requirements.
 Product standards introduced to some countries where none
previously existed.
 Manufacturer's responsibility clearly defined.

9. CE Marking
Directives:
Directives Title of Directives
2006/95/EC LowVoltage
87/404/EEC Simple PressureVessels
88/378/EE Safety of toys
89/106/EEC Construction products
2004/108/EC ElectromagneticCompatibility
(EMC)
2006/42/EC Machinery
89/686/EEC Personal Protective equipment
(PPE)
90/384/EEC Non- automatic weighing
instruments
90/385/EEC Active implantable medical devices
90/396/EEC Appliances burning gaseous fuels

10. CE Marking
Directives:
Directives Title of Directive
92/42/EEC Efficiency requirements for new
hot- water boilers fired with liquid
or gaseous fuels
93/15/EEC Explosives for civil uses
93/42/EEC Medical Devices
94/9/EC Equipment explosive atmospheres
(ATEX)
94/25/EC Recreational craft
95/16/EC Lifts
97/23/EC Pressure Equipment
98/79/EC In vitro diagnostic medical devices
1999/5/EC Radio Equipment and
TelecommunicationsTerminal
Equipment
2000/9/EC Cable installations designed to carry
persons
2004/22/EC Measuring instruments

11. Affixation of
the Marking
ToYour
Product:
 The CE Marking must be affixed by the manufacture after
completion of the requirements of the relevant directive/s.
 CE marking must be affixed according to its legal format visibly,
legibly and indelibly.
 If a Notified Body was involved in the production control phase, its
identification number must also be displayed.

12. HowToGet
Certified?
 Identify the EU requirements for your product
 Check whether your product meets the specific requirements
 Check whether your product must be tested by a Notified Body.
 TestYour Product.
 Compile the technical dossier.
 Affix the CE Marking and draft a declaration of conformity.

14. Technical
Documentation:
 The technical documentation provides information on the
design, manufacture, and operation of a product and
must contain all the details necessary to demonstrate the
product conforms to the applicable requirements.

15. How to draw up
technical
documentation:
The technical documentation should include at least:
• your name and address, or those of any authorized representatives
• a brief description of the product
• identification of the product, for example, the product's serial number
• the name(s) and address(es) of the facilities involved in the design and
manufacture of the product
• the name and address of any notified body involved in assessing the
conformity of the product
• a statement of the conformity assessment procedure that has been
followed
• the EU declaration of conformity
• label and instructions of use
• a statement of relevant regulations to which the product complies
• identification of technical standards with which compliance is claimed
• list of parts
• test results

16. Declaration of
Conformity:
 An EU declaration of conformity (DoC) is a mandatory
document that you as a manufacturer or your authorised
representative need to sign to declare that your products
comply with the EU requirements. By signing the DoC you
take full responsibility for your product's compliance with
the applicable EU law.

17. How to draw up
a declaration of
conformity:
As a manufacturer, it is your responsibility to draw up the EU declaration of
conformity (DoC). It should contain the following information:
 your name and full business address or that of your authorised representative
 the product's serial number, model or type identification
 a statement, stating you take full responsibility
 means of identification of product allowing traceability – this can include an image
 the details of the notified body which carried out the conformity assessment
procedure (if applicable)
 the relevant legislation with which the product complies, as well as any harmonised
standards or other means used to prove compliance
 your name and signature
 the date the declaration was issued
 supplementary information (if applicable)
For imported products, the importer must ensure that the product is accompanied
by the DoC and must keep a copy of it for 10 years after the product has been placed
on the market.
You must translate the EU declaration of conformity into the language or languages
required by the EU country in which your product is sold.