SIDDHARTHA CONSULTANCY SERVICES

CE MARKINGServices 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.

Add: D-35, Pandav Nagar, Opp. Mother Dairy New Delhi-92 www.scsuniversal.com

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 integratedservices to fulfil our customers’ requirements andexpectations. Our unmatched resources andunderstanding of global economics translate intoconsistent quality of customer services.

Our aim is to turn knowledge in to reality for the benefit ofour customers, our people and our societies.

SCS has team of qualified Consultants which includeEngineers with Management Backgrounds with vastIndustrial Expertise.

Our Values: Hard and dedicated team work coupled withintegrity & Commitments towards People and Societies.We believe in change.

We are thankful to give us an opportunity to introduce youthe roadmap for effective mapping of your existing systemto CE Marking for wide acceptability to Europe market. Youcan see above services offered for CE marking overviewalong with scope and activity plan for Documentation,Training and implementation.

We will appreciate your response in order to explain you indetail about our proposal, but if you have any question inthe mean time, you can reach us.

Sincerely yours,

Gajendra Khare

Director- Siddhartha Consultancy Services

Mobile- 09971090494, gkhare@scsuniversal.comgajendra.khare@gmail.com

We are a consulting firmbased in New Delhi Indiahaving high profile team ofCertified Lead Auditors for(ISO 9001, ISO 14001,OHSAS 18001, ISO 22000,and ISO 27001, CE Marking

Having wide & variety ofprofessional experienceand exposure to latest bestpractices followed globally.

Our objective is to addingvalue to those enterpriseslooking to drive-upbusiness. At SCS weprovide business solutionsto meet the vast majorityof company needs aroundbusiness improvement,hassle-free operations,excellence, and growth

CE MarkingDelhi-92 . www.scsuniversal.com

CE Mark is the gateway for the companies who want toexport to Europe. The European community hasimplemented a system to protect the health of consumersand user of manufactured products. CE Mark assures theuser of a product that it conforms to the requirements ofrelevant directive of European union and harmonizedEuropean standard. The License is granted by agenciesnotified by European Union.

WHAT DO YOU NEED TO KNOW TO GET AN ACCURATEOVERVIEW OF THE COSTS OF CE MARKING?

You need to clarify the following points before opt for CEMarking:

- Which CE directive or CE directives apply/applies tothe product?

- Which standards apply to the product? And dothese standards have the status of Europeanharmonized standards or not?

- Which certification procedure or proceduresapply/applies?

With this information you can compare quotes fromservice providers such as test laboratories, certificationbodies and consultants and ensure that will provide thesame service

BUT THERE IS MORE.

To determine the costs of CE certification you also shouldtake into account the following aspects:

a. Are you required to involve a 3rd party certificationbody, or are you allowed to do self-certification?The biggest myth about CE marking is:"To get CE marking, products must be tested and certifiedby a third party certification body".This myth has cost a lot of companies a lot of money. Inalmost 90% of the cases, the CE marking regulations allowproducts to be self-certified for CE marking. In other words,you can do the CE marking yourself and you are notrequired to have the product certified by a third partycertification body. Obviously, CE marking self-certificationcan save your company a lot of time and money.

Marking Navigation System is easy.

b. Is it possible for you to do in-house testing/inspections,

Many of the required test and conformity assessments canbe performed by your company. Simply because it is avisual inspection or because it does not require specialequipment and test equipment is available (or can beobtained).

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 areaccredited for various international markings andcertification schemes. With one basic test in combinationwith some targeted additional test, your product can beapproved for many markets, and thus you can spread thecosts of certification over a bigger number of products.

d. Can you buy CE approved parts or components thatwill make your own CE marking effort easier?I can give you a practical example: one of my clientsmanufacturers a small optical inspection tool (a small carwith a video camera) with a RF remote control module. TheRF module was purchased from a vendor, and it alreadywas CE approved. And as a result, my client did not have totest his product against the RF standards.

e. Have you thought about the internal companyresources you require for the CE marking? Do these haveto be included in your budget?

What I mean here is the costs of the persons who will haveto dedicate time to the initial CE marking, and afterward tokeeping updated with the regulations and standards.

f. Have you taken into consideration that the existingdesign may not pass the conformity assessments, and thatit needs to be modified? How much time and money doesit cost us to make design changes? How much does it costus to do the re-testing?

As you can see there are many things to consider. Allaspects mentioned above have an effect on the costs. Inmost cases you can do a lot yourself, possibly with some

Add: B-7&8, Ganesh Nagar,Pandav Nagar Complex New You too can learn to do CE self-certification. With the CE

or do you need to subcontract this?

guidance and instructions, and thus saving a lot of money.Risk analyses, the compilation of the Technical File,conformity assessment against essential requirements ofthe directives and standards, the Declaration ofConformity. These all can be done by you or yourcolleagues, if you invest a little time in learning how to doit.

The biggest costs in CE certification are inherent to thetime that test laboratories, certification bodies andconsultants need to spend on your products. I think that bylooking at your product, you can already estimate that thetime investment for conformity assessment, risk analysis orthe compilation alone is at least a full day of work, andlikely more. Multiply this with a reasonable hourly fee,

For product testing alone you often need several days torun the required test procedure. I have seen wear and teartests for construction products that take 1 month!Sure, you may find laboratories and consultants in themarket who claim they can do it for a very low fee. Myexperience and the experience of my clients with thesecompanies is that the provided services are very cheap aswell. Please consider this: the CE marking is aboutproviding evidence that the product complies with theapplicable requirements. In the case you have to involve atest laboratory or certification body, it is better to use awell-established, reputable company than a cheapunknown company. Because when your product's CEcompliance is challenged, its acceptance by authorities andyour customers depends on the reliability of the (test)certificate and report.

My advice: if you want to save money and time on CEcertification, do as much as you can by yourself yourself.Don't depend entirely on third parties and consultants.Perform the conformity assessment. Prepare the TechnicalFile. Carefully prepare your product for compliance testing,if you cannot conduct it yourself. But trust me: you canachieve a lot yourself, if you spend a little time to getfamiliar with the rules.

Whether the company can do some or all of theconformity assessments themselves, as well as the levelof support needed to prepare the required compliancedocuments, Technical File, user manual and productlabeling.

Which certification procedure or procedures applies/apply,is based on the technical specifications of a product, as well

as its 'intended purpose'. Only whenthese factors are clear, the correctCE directives (yes, a product can becovered by more than one CEdirective at the same time),European harmonized standards andcertification procedure can bedetermined.In many cases the CE directives offertwo or more certification proceduresthat may be used. The costsassociated with one or the otherprocedure can vary, and thus this isone of the aspects to keep in mind.

The Medical Device Directive(MDD):

The European medical devicedirective makes it mandatoryas of 06/28/1998 to fulfill CEcertification requirements inorder to export medicaldevices, of Class I, IIa, IIb, andIII to any country within theEuropean community. For U.S.firms, the recommendedstrategy is to pursue the CEcertification while the productis in the approval process bythe FDA. The CE certificationcan be often achieved prior tothe FDA's approval, thusenabling the device to be soldin Europe and generatingsubstantial revenues. Therequirements for CEcertification are very strict butif the product is in advancedclinical investigation or IDE(Investigational DeviceExemption) stages by the FDA,the CE certification can happenmuch quicker than the FDA's.

Medical Device classification ina nut shell (see 93/42/EEC):

The classification is similar to theFDA's, except for the sub-classification of (a) and (b) forclass II products. Class I is for

COUNTRIES

Netherlands

Norway

Portugal

Poland

Slovakia

Slovenia

Sweden

Spain

UnitedKingdom

Greece

Hungary

Iceland

Ireland

Italy

Luxembourg

Latvia

Lithuania

Malta

Austria

Belgium

Cyprus

CzechRepublic

Denmark

Finland

France

Estonia

Germany

low risk device, while Class III is for the higher riskdevices. The Classification is addressed in detail in93/42/EEC Annex IX. Here are examples ofclassifications:

Class I:Wheel Chairs, Patient electrodes, Scalpels. Dental

Drills, Wound Management systems, Hearing AidTester.

Class IIa:All patient monitoring equipment, Syringes. Needles,

Ultrasound devices, External ECGs, Diagnosis devices.

Class IIb:Lasers Devices for application, Internal ECGs, RF

Generators, Non-energized implants, Treatmentdevices.

Class III :Energized implants, All Intracardiac applications, Heart

valves, Cauterters, Non-energized implants, Alldevices 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.

Class IIa & IIb :

Hold a Technical file* Obtain ISO 9001/ISO 13485certification.

Audit by notified body according to Annex II. Apply CEmark.

Class III:Hold a Technical file* Obtain ISO 9001/ISO 13485

certification.Audit by notified body according to Annex II.Product Dossier Exam by notified body according to

Annex II. Apply CE mark.

Technical File Content :

General product description, Design drawings,methods of manufacture and diagrams ofcomponents and sub-assemblies, Description andexplanation of above-mentioned drawings anddiagrams, Result of risk analysis and list of standardsreferred to in Article 5 of 93/42/EEC, applied in full orin part, and descriptions of the solutions adopted ifnot applied in full. Description of the methods used ifthe device require sterility. The results of the designcalculations and of the inspections carried out. If thedevice is to be connected to other device(s), proofmust be provided that it conforms to the essentialrequirements when connected. The tests' reportsand where appropriate, clinical data in accordancewith Annex X of 93/42/EEC and the label andinstructions for use.

Director, Mr. Gajendra KhareM.Sc. (Maths), DIMS, MPA

Former HR and Administration Manager, Apparel Group UAE; Mr. Khare has about 14 years of working experience with many prestigious organizationof the country and overseas in the field of Human Resource Development (HRD), Administration, Liasoning, ISO-9000, MIS (Management InformationSystems) and others. He has worked on a number of HRD and quality related assignments of various organizations. He has also worked in the area ofManagement 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, ISO13485:2003 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

Guideline

Products or Title Mandatory from

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