ce mark ppt i 3 consulting (1)

8/3/2019 Ce Mark Ppt i 3 Consulting (1)

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CE Marking of Medical Device


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CE Marking of Medical Devicey The letters "CE" are the abbreviation of French phrase

"Conformit Europene" which literally means "European

Conformity". The term initially used was "EC Mark" and it

was officially replaced by "CE Marking" in the Directive

93/68/EEC in 1993. "CE Marking" is now used in all EU

official documents.


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General principles of the CE

markingy The CE marking shall be affixed only by the manufacturer

or his authorized representative.


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CE Markingy The CE marking shall be affixed only to products to

which its affixing is provided for by specificCommunity harmonization legislation, and shall not

be affixed to any other product.


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CE Markingy The CE marking shall be the only marking which attests

the conformity of the product with the applicable

requirements of the relevant Community harmonization

legislation providing for its affixing.


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CE Markingy The affixing to a product of markings, signs or inscriptions

which are likely to mislead third parties regarding the meaning

or form of the CE marking shall be prohibited. Any other

marking may be affixed to the product provided that the

visibility, legibility and meaning of the CE marking is not

thereby impaired.


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CE Markingy Member States shall ensure the correct implementation of the

regime governing the CE marking and take appropriate action in the

event of improper use of the marking. Member States shall also

provide for penalties for infringements, which may include criminal

sanctions for serious infringements. Those penalties shall be

proportionate to the seriousness of the offence and constitute an

effective deterrent against improper use.


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CE Markingy By affixing or having affixed the CE marking, the

manufacturer indicates that he takes responsibility for the

conformity of the product with all applicable

requirements set out in the relevant Community

harmonization legislation providing for its affixing


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Why is CE Marking

called the "Passport to Europe" ?y The European Union's 'New Approach directives' are

mandatory on all member countries to enact through

national legislation.

Its an offence to place a product on the market without

CE Marking. The manufacturer is legally responsible for

ensuring that the product confirms to the requirements

of the directive and for applying CE Marking


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How Do You Benefit From CE Marking?

y The EU introduced the CE marking scheme to make trade easier and cheaper between EU

countries. It means that a manufacturer claims that their product conforms to the minimum

legal requirements for health and safety as laid down in EU directives.

yThe great benefit for manufacturers is that there is now only one set of requirements and

procedures to comply with in designing and manufacturing a product for the entire EEA. The

various and conflicting national regulations are eliminated. As a result, the product no longer

needs to be adapted to the specific requirements of the different member states of the EEA.

y In addition, it may be considered a benefit that by implementing the requirements, the

product will be safer for the user and this may also reduce damage and liability claims.

Additional benefits may include your product being made safer for end-users


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In shorty ....CE Marking is a product certification for organizatons

that want to penetrate or develop a particular market or

sales opportunity.

CE Marking certificate helps to meet sales and quality

objectives. CE Mark certificate opens the door for entrythe product to Europe.


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How Do You Acquire CE Markingy Determine if any directives apply to your product. If more than

one applies you will have to comply with all of them.

y Determine the extent to which your product complies with the

essential requirements for design and manufacturing in theapplicable directive(s).

y Choose the conformity assessment procedure from theoptions called out by the directive for your product.The directives often use a series of questions about the nature

of your product to classify the level of risk and refer to a chartcalled "Conformity Assessment Procedures". The chartincludes all of the acceptable options available to amanufacturer to certify their product and affix the CE Marking.


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How Do You Acquire CE MarkingOptions for products with minimal risk include self certification where the

manufacturer prepares a declaration of conformity and affixes the CE Marking to

their own product.

Options for products with greater risks can require tests, audits or additional

certificates from a notified body.

Select the applicable product standards and test methods for your product and

select an independent lab If the product testing is to be done externally.


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How Do You Acquire CE Marking

y Establish an authorized representative for regulatory affairs inthe European Union for your product. Some directives require

that a manufacturer designate in Europe a representative toproduce technical documentation in a timely fashion whencalled upon to do so.

The directives require for many products that a technical filebe prepared by the manufacturer. The technical file holds

information that verifies that the testing was conductedproperly and that the product complies with applicablestandards.


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How Do You Acquire CE Markingy Prepare a declaration of conformity that includes a list of the

directives and standards that your product conforms to; productidentification, the manufacturer's name, address and signature.

The declaration of conformity contains information adequate fortracing the product back to the manufacturer or the authorizedrepresentative in the European Union.

y Affix the CE Marking to your product. There are specific rules to

adhere to in CE Marking. These rules address the size and location ofthe marking, affixing the CE Marking to products, packaging andmaterial or documents shipped with the product, and specificlimitations on when and who is permitted to affix the CE Marking.


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Who's Going To Enforce The Requirement For

CE Marking

y Each member state of the European Union is bound to

adopt into their National Law, regulations and

administrative provisions to ensure that products

placed on the market are safe. Each country has its

own way of handling enforcement


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Who's Going To Enforce The

Requirement For CE Markingy Many have added staff specifically to conduct spot checks

against implemented directives and respond to

complaints. Countries have also set in place a

combination of return-to-origin procedures, financial

penalties, criminal prosecution, etc.


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Who's Going To Enforce The

Requirement For CE Markingy European Union legislation makes European importers

liable for the products they import, including the

machinery they provide to their employees for work.

Exporters are finding that no matter how interested a

prospective European customer may be in their product,

they will not risk importing non-conforming products

when accidents will generate legal action against them.


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CE Mark Medical Device

Technical Consultancy Service

Call = + 91 80 5064 8432

www.i3cglobal.com

ce mark ppt i 3 consulting (1)

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