SIDDHARTHA CONSULTANCY SERVICES

Add: B-7&8, Ganesh Nagar, Pandav Nagar Complex, New Delhi-92 www.scsuniversal.com

CE MARKING
Services Offered by SCS:
 Liaison with notified bodies and competent authorities in EC.
 Auditing against MDD and essential requirements.
 Assisting with clinical investigations to meet multi-national requirements and conformance
with EN 540 and US FDA GCP requirements.
 Arrange representative in the EC.
 Assist in Vigilance reporting.
 Assist in registration of distributed products with competent authorities in each EC country.
 Customer Complaint handling in EC.
 Process Validations (IQ/OQ/PQ/PPQ)
 Software Validations.
 Packaging & Shelf Life Validations.
 Failure Modes & Effects Analysis .
 Quality Systems Audits.
 CE Technical File Generation.
 Statistical Methodologies & Training.
 Measurement Systems Validation.
 Sterilization Validations.
 Biocompatibility Testing.
 GMP Compliant Manufacturing Systems.
 Environmental Clean room Controls.

We are a consulting firm
based in New Delhi India
having high profile team of
Certified Lead Auditors for
(ISO 9001, ISO 14001,
OHSAS 18001, ISO 22000,
and ISO 27001, CE Marking
Having wide & variety of
professional experience
and exposure to latest best
practices followed globally.
Our objective is to adding
value to those enterprises
looking to drive-up
business. At SCS we
provide business solutions
to meet the vast majority
of company needs around
business improvement,
hassle-free operations,
excellence, and growth
The quality services we deal are as follows.
• ISO 9001 - Quality Management System
• ISO 14001 - Environment Management System
• OHSAS 18001 - Occupational Health & Safety
• ISO 22000, BRC, HACCP - Food Safety Management
• ISO/TS 16949 Global Automotive Management System
• ISO 27001 - Information security Management System
• SDLC, CMMi – Software Development Life Cycle
• Design Management / CE Marking
At SCS we believe in offering high-quality integrated
services to fulfil our customers’ requirements and
expectations. Our unmatched resources and
understanding of global economics translate into
consistent quality of customer services.
Our aim is to turn knowledge in to reality for the benefit of
our customers, our people and our societies.
SCS has team of qualified Consultants which include
Engineers with Management Backgrounds with vast
Industrial Expertise.
Our Values: Hard and dedicated team work coupled with
integrity & Commitments towards People and Societies.
We believe in change.
We are thankful to give us an opportunity to introduce you
the roadmap for effective mapping of your existing system
to CE Marking for wide acceptability to Europe market. You
can see above services offered for CE marking overview
along with scope and activity plan for Documentation,
Training and implementation.
We will appreciate your response in order to explain you in
detail about our proposal, but if you have any question in
the mean time, you can reach us.
Sincerely yours,
Gajendra Khare
Director- Siddhartha Consultancy Services
Mobile- 09971090494, gkhare@scsuniversal.com
gajendra.khare@gmail.com
Add: B-7&8, Ganesh Nagar,Pandav Nagar Complex New
Delhi-92 . www.scsuniversal.com
CE Marking
CE Mark is the gateway for the companies who want to
export to Europe. The European community has
implemented a system to protect the health of consumers
and user of manufactured products. CE Mark assures the
user of a product that it conforms to the requirements of
relevant directive of European union and harmonized
European standard. The License is granted by agencies
notified by European Union.
WHAT DO YOU NEED TO KNOW TO GET AN ACCURATE
OVERVIEW OF THE COSTS OF CE MARKING?
You need to clarify the following points before opt for CE
Marking:
- Which CE directive or CE directives apply/applies to
the product?
- Which standards apply to the product? And do
these standards have the status of European
harmonized standards or not?
- Which certification procedure or procedures
apply/applies?
With this information you can compare quotes from
service providers such as test laboratories, certification
bodies and consultants and ensure that will provide the
same service
BUT THERE IS MORE.
To determine the costs of CE certification you also should
take into account the following aspects:
a. Are you required to involve a 3rd party certification
body, or are you allowed to do self-certification?
The biggest myth about CE marking is:
"To get CE marking, products must be tested and certified
by a third party certification body".
This myth has cost a lot of companies a lot of money. In
almost 90% of the cases, the CE marking regulations allow
products to be self-certified for CE marking. In other words,
you can do the CE marking yourself and you are not
required to have the product certified by a third party
certification body. Obviously, CE marking self-certification
can save your company a lot of time and money.
You too can learn to do CE self-certification. With the CE
Marking Navigation System is easy.
b. Is it possible for you to do in-house testing/inspections,
or do you need to subcontract this?
Many of the required test and conformity assessments can
be performed by your company. Simply because it is a
visual inspection or because it does not require special
equipment and test equipment is available (or can be
obtained).
c. Do you want to combine CE marking with other
(private) certifications/markings (e.g. GS, TUV, NEMKO,
DEMKO, SEMKO etc. etc.)?
There are testing and certification bodies that are
accredited for various international markings and
certification schemes. With one basic test in combination
with some targeted additional test, your product can be
approved for many markets, and thus you can spread the
costs of certification over a bigger number of products.
d. Can you buy CE approved parts or components that
will make your own CE marking effort easier?
I can give you a practical example: one of my clients
manufacturers a small optical inspection tool (a small car
with a video camera) with a RF remote control module. The
RF module was purchased from a vendor, and it already
was CE approved. And as a result, my client did not have to
test his product against the RF standards.
e. Have you thought about the internal company
resources you require for the CE marking? Do these have
to be included in your budget?
What I mean here is the costs of the persons who will have
to dedicate time to the initial CE marking, and afterward to
keeping updated with the regulations and standards.
f. Have you taken into consideration that the existing
design may not pass the conformity assessments, and that
it needs to be modified? How much time and money does
it cost us to make design changes? How much does it cost
us to do the re-testing?
As you can see there are many things to consider. All
aspects mentioned above have an effect on the costs. In
most cases you can do a lot yourself, possibly with some
guidance and instructions, and thus saving a lot of money. as its 'intended purpose'. Only when
COUNTRIES
Risk analyses, the compilation of the Technical File, these factors are clear, the correct
conformity assessment against essential requirements of CE directives (yes, a product can be Netherlands
the directives and standards, the Declaration of covered by more than one CE
Conformity. These all can be done by you or your directive at the same time), Norway
colleagues, if you invest a little time in learning how to do European harmonized standards and
Portugal
it. certification procedure can be
determined. Poland
The biggest costs in CE certification are inherent to the In many cases the CE directives offer
time that test laboratories, certification bodies and two or more certification procedures Slovakia
consultants need to spend on your products. I think that by that may be used. The costs
looking at your product, you can already estimate that the associated with one or the other Slovenia
time investment for conformity assessment, risk analysis or procedure can vary, and thus this is Sweden
the compilation alone is at least a full day of work, and one of the aspects to keep in mind.
likely more. Multiply this with a reasonable hourly fee, Spain
The Medical Device Directive
For product testing alone you often need several days to (MDD): United
run the required test procedure. I have seen wear and tear The European medical device Kingdom
tests for construction products that take 1 month! directive makes it mandatory Greece
Sure, you may find laboratories and consultants in the as of 06/28/1998 to fulfill CE
market who claim they can do it for a very low fee. My certification requirements in Hungary
experience and the experience of my clients with these order to export medical
companies is that the provided services are very cheap as devices, of Class I, IIa, IIb, and Iceland
well. Please consider this: the CE marking is about III to any country within the
Ireland
providing evidence that the product complies with the European community. For U.S.
applicable requirements. In the case you have to involve a firms, the recommended Italy
test laboratory or certification body, it is better to use a strategy is to pursue the CE
well-established, reputable company than a cheap certification while the product Luxembourg
unknown company. Because when your product's CE is in the approval process by
Latvia
compliance is challenged, its acceptance by authorities and the FDA. The CE certification
your customers depends on the reliability of the (test) can be often achieved prior to Lithuania
certificate and report. the FDA's approval, thus
enabling the device to be sold Malta
My advice: if you want to save money and time on CE in Europe and generating
Austria
certification, do as much as you can by yourself yourself. substantial revenues. The
Don't depend entirely on third parties and consultants. requirements for CE Belgium
Perform the conformity assessment. Prepare the Technical certification are very strict but
File. Carefully prepare your product for compliance testing, if the product is in advanced Cyprus
if you cannot conduct it yourself. But trust me: you can clinical investigation or IDE
Czech
achieve a lot yourself, if you spend a little time to get (Investigational Device
Republic
familiar with the rules. Exemption) stages by the FDA,
the CE certification can happen Denmark
Whether the company can do some or all of the much quicker than the FDA's.
conformity assessments themselves, as well as the level Finland
of support needed to prepare the required compliance Medical Device classification in
France
documents, Technical File, user manual and product a nut shell (see 93/42/EEC):
labeling. The classification is similar to the Estonia
FDA's, except for the sub-
Which certification procedure or procedures applies/apply, classification of (a) and (b) for Germany
is based on the technical specifications of a product, as well class II products. Class I is for
 low risk device, while Class III is for the higher risk Hold a Technical file* Obtain ISO 9001/ISO 13485
devices. The Classification is addressed in detail in certification.
93/42/EEC Annex IX. Here are examples of Audit by notified body according to Annex II. Apply CE
classifications: mark.

Class I: Class III:

Wheel Chairs, Patient electrodes, Scalpels. Dental Hold a Technical file* Obtain ISO 9001/ISO 13485
Drills, Wound Management systems, Hearing Aid certification.
Tester. Audit by notified body according to Annex II.
Product Dossier Exam by notified body according to
Class IIa: Annex II. Apply CE mark.
All patient monitoring equipment, Syringes. Needles,
Ultrasound devices, External ECGs, Diagnosis devices. Technical File Content :

Class IIb: General product description, Design drawings,

Lasers Devices for application, Internal ECGs, RF
Generators, Non-energized implants, Treatment
devices.
Class III :
Energized implants, All Intracardiac applications, Heart
valves, Cauterters, Non-energized implants, All
devices in contact with the central nervous system.
Recommended compliance routes :
Class I :
Hold a Technical file*
Self-Declaration of Conformity according to Annex VII.
Observe provisions of the procedures referred to in
Annex IV, V or VI of 93/42/EEC for "sterile" or
"Measuring" function devices.
methods of manufacture and diagrams of
components and sub-assemblies, Description and
explanation of above-mentioned drawings and
diagrams, Result of risk analysis and list of standards
referred to in Article 5 of 93/42/EEC, applied in full or
in part, and descriptions of the solutions adopted if
not applied in full. Description of the methods used if
the device require sterility. The results of the design
calculations and of the inspections carried out. If the
device is to be connected to other device(s), proof
must be provided that it conforms to the essential
requirements when connected. The tests' reports
and where appropriate, clinical data in accordance
with Annex X of 93/42/EEC and the label and
instructions for use.

Class IIa & IIb :

Director, Mr. Gajendra Khare

M.Sc. (Maths), DIMS, MPA

Former HR and Administration Manager, Apparel Group UAE; Mr. Khare has about 14 years of working experience with many prestigious organization
of the country and overseas in the field of Human Resource Development (HRD), Administration, Liasoning, ISO-9000, MIS (Management Information
Systems) and others. He has worked on a number of HRD and quality related assignments of various organizations. He has also worked in the area of
Management Information Systems and implemented ERP modules in industries.

He has been a member of various professional organizations in the fields of HR and quality etc.
Mr. Gajendra Khare has developed and implemented various HR solutions to the industries successfully. He has also implemented ISO-9001:2008, ISO
13485:2003 CE and WHO: GMP certification and also handled various administrative assignments and completed successfully.

Contact: +919971090494; gkhare@scsuniversal.com; gajendra.khare@gmail.com, web: www.scsuniversal.com

 Directive or Products or Title Mandatory from

Guideline
Type A: Basic Directives ( for all products)
85/374/EEC Liability for Defective Products 30 Jul 1988
1999/34/EC Liability for Defective Products (amending) 10 May 1999
92/59/EEC General Products Safety 1 Jan 1997
2001/95/EC ( new ) General Products Safety Directive 1 Jan 2003
93/68/EEC "CE Marking" Directive 22 Jul 1993
93/465/EEC Conformity Assessment Procedures & CE Marking Rules 22 Jul 1993
Guideline Guide to Implementation of directives based on new approach & global approach Pub. 2000

Type B: Generic Directives (take precedence over Type A)

73/23/EEC Low Voltage Electrical Equipment (LVD) 1 Jan 1997
Framework 2000&2001 Framework of implementation of LVD 73/23/eec (79pages) Pub. 2001
Guideline Guideline on Low Voltage Directive (LVD) 73/23/EEC & Annex I, II Pub. Jul 1997
89/336/EEC Electromagnetic Compatibility (EMC) 1 Jan 1996
Guideline Guideline on Directive of Electromagnetic Compatibility (EMC) 89/336/eec Pub. 2001
Tech-Aspects Technical-Aspects relating Electromagnetic Compatibility EMC 89/336/eec (150pages) Pub. 2001
Framework Framework of implementation of EMC Directive 89/336/EEC Pub. 2000
2002/95/EC RoHS- Restriction of use of Hazardous Substances in Electrical and Electronic Equipment -
2002/96/EC WEEE- Waste from Electrical and Electronic Equipment -
Type C: Product-Specific Directives (take precedence over Type A & B)
87/404/EEC Simple Pressure Vessels 1 Jul 1992
88/378/EEC Toys 1 Jan 1990
Guideline Guidance to 88/378/eec Toys (for Scooter & FloatingSeats) Pub. 2001
89/106/EEC Construction Products 27 Jun 1991
Guideline Guidance to Directive 89/106/eec: Construction Products Pub. 2001
89/686/EEC Personal Protective Equipment (PPE) 1 Jul 1995
UsefulFacts Useful Facts relating to Directive 89/686/eec PPE (143pages) Pub. 2001
Framework Framework of implementation of (PPE) Directive 89/686/eec (13pages) Pub. 2001
90/384/EEC Non-automatic Weighing Instruments 1 Jan 2003
90/384/EEC Appliances Burning Gaseous Fuels (AppliGas) 1 Jan 1996
Framework Framework of implementation of (AppliGas) Directive 90/396/eec Pub. 2001
92/42/EEC Efficiency of (Liquid or Gaseous fueled) Hot Water Boilers 1 Jan 1998
93/15/EEC Explosives for Civil Uses 1 Jan 2003
93/42/EEC Medical Devices 14 Jun 1998
Guidelines Guidelines for Classification of Medical Devices Pub. 2001
Guideline Guideline relating to the demarcation between Directives 90/385/eec, 93/42/eec and 65/65/eec. Pub. 1998
90/385/EEC Active Implantable Medical Devices 1 Jan 1995
98/79/EC In Vitro Diagnostic Medical Devices 7 Dec 2003
Guideline Guideline on Medical Devices Vigilance System Pub. 1998
93/65/EEC Air Traffic Management Equipment & Systems 19 Jul 1994
94/9/EC Equipment used in Potentially Explosive Atmospheres (Atex) 1 Jul 2003
Framework Framework of implementation of (Atex) Directive 94/9/ec, 7pages Pub. 2001
Guideline Guideline on directive 94/9/ec (Atex) Pub. 2000
94/25/EC Recreational Craft 16 Jun 1998