This presentation discusses CE marking and the process of implementing it. CE marking shows that a product has met EU health, safety, and environmental requirements. The presentation outlines the key directives, conformity assessment procedures, notified bodies, and steps to affix the CE mark. It also discusses assessing medical devices and deciding on rules based on factors like invasiveness and intended use. Attendees are encouraged to provide feedback to help improve future presentations.

1. Welcome to presentation
by
NETPECKERS CONSULTING (P) LTD.
An ISO 9001:2000 compliant organization
On
Advantages, importance & procedure of implementing
CE Marking DURATION 25 MINUTES.

2. CE stands for
Conformance Europa
www.netpeckers.net

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

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.
www.netpeckers.net

5. Medical Device Directive
! Active implantable devices
! Medical devices
! Disposables
! Accessories
! Lab instruments & gadgets
www.netpeckers.net

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

7. www.netpeckers.net

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 www.netpeckers.net

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
www.netpeckers.net

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+ Assessment
of
Conformity
Product of for FPC
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
www.netpeckers.net

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)
www.netpeckers.net

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
www.netpeckers.net

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.
www.netpeckers.net

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.
www.netpeckers.net

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
Principal Consultant
san@netpeckers.net
M-9426077684
An ISO 9001:2000 complaint organization
www.netpeckers.net