CE marking and CE
certification what is it why you need it who can apply
Who Can Apply For
CE Marking?
Are you a
businessman or an electronic and medical device manufacturer? You will come to
know about CE marking and its CE certification. But in some cases most of these
people will not come across its importance, Why we need, What it does, how to
apply, who can apply, and more and more things. They just only do it as a
normal process. When they start knowing its importance, it helps their business
growth as well. Read below my article to make my above-said words true.
Learn How To Do CE
marking:
Steps to CE
marking by the CE marking consultants:
1. Identify
the relevant directives and its standards,
2. Verify
the product’s specific requirements,
3. Identify
whether an independent conformity assessment (Notified Body Medical Device) is necessary or not,
4. Test the
product,
5. Create
the technical documentation, and
6. Finally,
Add the CE mark to the specific product.
What are the CE
Marking and CE certification?
CE marking
became standard to prove the devices' safety among its environment. It means
European Conformity. In short CE marking is a certification given to any
devices like electronic items and medical devices, to assure its safety around
the human and living environment and to make sure that the people and kids are
safe from it.
Why Does This Certification
Require?
CE marking
for the electrical, electronic and medical device says that the manufacturer
claims that a product meets all the essential requirements of all relevant
European Medical Device Directives and makes it ready for its usage to the
customers.
8 Interesting Thing
About CE Marking and its Certification:
1.
The CE mark is a mandatory conformity one marking for certain products
sold within the European Economic Area (EEA) since 1985
2.
CE marking is the self-declaration where a manufacturer proves
compliance with EU safety, health, and
environmental protection legislation and confirms a product’s compliance with
relevant requirements
3.
The authorized or manufacturer representative must keep technical
documentation for several years (the number is dependent on the product type)
after the last product has been placed on the market
4.
Each EU country is responsible to enforce the CE marking, by banning
products and levying fines for non-compliance
5.
Unsafe products are shared in the EU via RAPEX – a rapid alert system
on measures taken to prevent or restrict the marketing or use of products
posing a serious risk to the health and safety of consumers
6.
There is a very similar logo where the CE stands for Chinese Export or
China Export and this has nothing to do with European conformity
7.
The size of the CE mark must be at least 5 mm high. If the appearance
or size of a product do not allow for the CE marking to be affixed on a product
itself, the marking has to be affixed to its packaging or accompanying documents
8.
Pre-testing in the early product development process can reduce cost
and time to marketing
MedDeviceCorp
has tested and provided thousands of products to support CE Marking and CE
certification for product safety, electromagnetic compatibility, and energy
efficiency. Contact us today to tap the experience and skill of our CE
expertise team and get quick Medical
Device CE Marking.
WE
EXTENDED OUR SERVICES IN SERVING:
Call +44 2037594094
75 Executive Drive, Suite 303, Aurora, Illinos – 60504
Twitter: https://twitter.com/meddevicecemark
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