Ce Brochure

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

• 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.

The quality services we deal are as follows. • ISO 9001 - Quality Management System • ISO 14001 - Environment Management System • OHSAS 18001 - Occupational Health & Safety

Sincerely yours, Gajendra Khare Director- Siddhartha Consultancy Services Mobile09971090494, [email protected]

[email protected]

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: -

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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. Risk analyses, the compilation of the Technical File, conformity assessment against essential requirements of the directives and standards, the Declaration of Conformity. These all can be done by you or your colleagues, if you invest a little time in learning how to do it. The biggest costs in CE certification are inherent to the time that test laboratories, certification bodies and consultants need to spend on your products. I think that by looking at your product, you can already estimate that the time investment for conformity assessment, risk analysis or the compilation alone is at least a full day of work, and likely more. Multiply this with a reasonable hourly fee, For product testing alone you often need several days to run the required test procedure. I have seen wear and tear tests for construction products that take 1 month! Sure, you may find laboratories and consultants in the market who claim they can do it for a very low fee. My experience and the experience of my clients with these companies is that the provided services are very cheap as well. Please consider this: the CE marking is about providing evidence that the product complies with the applicable requirements. In the case you have to involve a test laboratory or certification body, it is better to use a well-established, reputable company than a cheap unknown company. Because when your product's CE compliance is challenged, its acceptance by authorities and your customers depends on the reliability of the (test) certificate and report. My advice: if you want to save money and time on CE certification, do as much as you can by yourself yourself. Don't depend entirely on third parties and consultants. Perform the conformity assessment. Prepare the Technical File. Carefully prepare your product for compliance testing, if you cannot conduct it yourself. But trust me: you can achieve a lot yourself, if you spend a little time to get familiar with the rules. Whether the company can do some or all of the conformity assessments themselves, as well as the level of support needed to prepare the required compliance documents, Technical File, user manual and product labeling. Which certification procedure or procedures applies/apply, is based on the technical specifications of a product, as well

as its 'intended purpose'. Only when these factors are clear, the correct CE directives (yes, a product can be covered by more than one CE directive at the same time), European harmonized standards and certification procedure can be determined. In many cases the CE directives offer two or more certification procedures that may be used. The costs associated with one or the other procedure can vary, and thus this is one of the aspects to keep in mind.

COUNTRIES Netherlands Norway Portugal Poland Slovakia Slovenia Sweden Spain

The Medical Device Directive (MDD): The European medical device directive makes it mandatory as of 06/28/1998 to fulfill CE certification requirements in order to export medical devices, of Class I, IIa, IIb, and III to any country within the European community. For U.S. firms, the recommended strategy is to pursue the CE certification while the product is in the approval process by the FDA. The CE certification can be often achieved prior to the FDA's approval, thus enabling the device to be sold in Europe and generating substantial revenues. The requirements for CE certification are very strict but if the product is in advanced clinical investigation or IDE (Investigational Device Exemption) stages by the FDA, the CE certification can happen much quicker than the FDA's.

United Kingdom Greece Hungary Iceland Ireland Italy Luxembourg Latvia Lithuania Malta Austria Belgium Cyprus Czech Republic Denmark Finland

Medical Device classification in a nut shell (see 93/42/EEC): The classification is similar to the FDA's, except for the subclassification of (a) and (b) for class II products. Class I is for

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low risk device, while Class III is for the higher risk devices. The Classification is addressed in detail in 93/42/EEC Annex IX. Here are examples of classifications:

Hold a Technical file* Obtain ISO 9001/ISO 13485 certification. Audit by notified body according to Annex II. Apply CE mark.

Class I: Wheel Chairs, Patient electrodes, Scalpels. Dental Drills, Wound Management systems, Hearing Aid Tester.

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.

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, 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.

Technical File Content : General product description, Design drawings, 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; [email protected]; [email protected], 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