This presentation provides an overview of CE Marking and the process for manufacturers to obtain CE Marking certification through Netpeckers Consulting (P) Ltd. in order to export products to European countries. CE Marking standards like the Medical Device Directive and procedures for conformity assessment including technical file reviews and audits are discussed. Contact information is provided at the end for manufacturers to request a quotation to begin the CE Marking certification process.

1. Welcome to presentation
by
NETPECKERS CONSULTING (P) LTD.
An ISO 9001:2000 compliant organization
On
Advantages, importance & procedure of implementing
CE Marking

2. CE stands for
Conformance Europa

3. Is a product standard
For manufacturers interested in
exporting their products to any
country in European Union or
European Economic Area
(EEA)

4. How do you start
What is the type of product that
you have
As there are Directives defined for
category of products, Identify the
right Directive.

5. Medical Device Directive
Active implantable devices
Medical devices
Disposables
Accessories
Lab instruments & gadgets

6. CE Marking process @ Netpeckers Consulting (P) Ltd.
Certification inquiry /Request for proposal
Application form / Registration
Identify Directive Standard
Review Technical file
Compliance audit / Inspection & Testing
CE Notified /National Laboratory
Verification /Declaration of conformity/ Affix CE Mark
Certificate of compliance / Verification
Surveillance audit
Satisfied customer

8. Available Directives
Medical Devices (MDD)
New hot water boiler
Gas Appliances
Explosives for civil uses
Recreational craft
Non automatic weighing Instruments
Active implantable medical devices
Equipment for explosive atmosphere
Telecommunication terminal equipments
Satellite earth station for telecom
Lifts
House hold appliances (Energy efficient)
Pressure equipment devices
Low voltage equipment (LVD)
Simple pressure vessel
Safety for toys
Construction products (CPD)
Electromagnetic compatibility (EMC)
Machinery safety
Personnel Protection Equipment (PPE)
Marine equipments
Other industry

9. Conformity Assessment Procedure
Self Declaration Voluntary Certification Mandatory Certification
Manufacture CE Notified & Examination by CE
Performa Competent body Notified & Competent
Assessment Assessment body
Manufacturer’s Manufacturer’s Assessment by EC
Technical file technical file with EC body
body report
Manufacturer Technical file with EC
Issues declaration of EC body issues body report
conformity & affixes certificate & Approval
CE Marking mark EC Body issues
certificate & approval
Declaration of mark
conformity & Affixes
CE Marking by Declaration of
Manufacturer conformity & Affixes
CE Mark by
manufacture.

10. H Module system for selection
Design of the product
B
A
AA
C D E F G H

11. Legends
A – Internal control of production
B – EC Type examination
C – Conformity of type
D – Production quality assurance
E – Production quality management
F – Product verification
G – Unit verification
H – Full quality system

12. Pathway to affixing the CE
FPC
system
EC
1+ Initial Type Test
Certificate
of CE
Series by Conformity 0086
production Notified Body for Product
1
EC
Certificate
2+ of
Conformity
Product Assessment
for FPC
of
Factory & FPC
2 by
Notified Body
Individual
production
3 CE
Initial Type Test Manufacturer’s
4 by EC
manufacturer Declaration
of Conformity

13. Structure of bodies governing CE
Marking European Commission
Licensed Laboratory Notified body with number
Like Med cert 0482
Indian Partner like
ICS
Consulting Agency
Like Netpeckers Consulting (P) Ltd.
Organization

14. Technical file consists of
Quality management system docs. Like ISO
9001 : 2000
Review other standards applicable like
ISO 13485 – EN 46001-2-3
BIS 13488

15. Assessment procedure for MDD
Select from Non-active device(rule1,2,3,4)
Time of continuous use
Invasiveness (rule 5,6,7,8)
Active devices (9,10,11,12)
Special rules (13-18)

16. How to decide continuous use on
patient
Transient – less than 30 minutes
Short term – less than 30 days
Long term – more than 30 days

17. Type of Invasiveness
Non invasive
Invasive through body orifice
Surgical invasive
Implantable device
Class IA – Self certification
Annexure VII of MDD
Others need to be assessed on product &
company basis.

18. How do you start
Details needed are
– Filling the Quotation Request form
– Providing complete details about the production &
marketing of product
– Target countries in Europe to sell
– We assess & provide complete road map with
techno-commercial proposal for the same based
on information provided by you.

19. Thank you for joining in the presentation
Please fill in the feedback form
Which would help us to be more precise
In our efforts.
Sanjay Punjabi
Certified Auditor
san@netpeckers.net
M-9426077684
An ISO 9001:2000 complaint organization