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8/3/2019 Ce Mark Ppt i 3 Consulting (1)
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CE Marking of Medical Device
8/3/2019 Ce Mark Ppt i 3 Consulting (1)
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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
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