What is the process of Medical Device CE MARKING?
In order to commercialize
medical as well as IVD devices in Europe, a CE mark certificate is needed. This
certificate is specially required to verify the conditions that a device meets
the regulatory requirements of the directive of medical devices as they apply
to each and every product.
What is the Process of
medical device CE marking?
There are various steps in which the ce marking of medical devices completed.
You first need to determine which medical device directive applies to your
device. Determine the classification of your device whether they are sterile
and non measuring, or class2 or class 2 A or class 3. Most companies use the
ISO 13485 standard to get hold of the QMS compliance. You need to prepare a
technical file that provides detailed information on all your medical devices
that demonstrate compliance. Appoint an authorized representative who is
located in Europe. They should be qualified enough to handle all kinds of
regulatory issues. After registering all medicaldevice CE marking you need to fill up a clinical data sheet.
How are medical devices
classified?
A medical device may be classified as Class1, Class2, and
Class3 with Class 3 covering the highest amount of risk products. The higher the
classification the greater would be the rate of evaluation. All medical devices
require a third party intervention known as the Notified body. Classification
of a medical device depends on a number of factors. How long are the devices
going to be used, whether or not the device is surgically invasive, whether the
device is active, whether the device contains a substance, which is medicinal?
What must be done before the
medical device is CE marked?
What are the Classification of the medical device CE marking devices?Before the medical device is CE marking service it is important to prepare technical documents to show that the product is compliant with the applicable essential requirements and conformity assessment procedures of the applicable device directive. The device must be registered with the competent authority. A device-specific CE Certificate should be received from the notified authority. The medical device CE marking process is simple when undertaken with a good company.
There are three classes of devices that need to be CE marked.
The Class1 devices have low risk such as external patient support products, the
class 2 devices have minimum risk like electro medical devices, and the class 3
devices contain the most risk factors such as cardiovascular catheters.
Can I join a medical deviceCE marking training course?
You can become a CE marking leader and ensure speedy
access to the market by taking up a CE marking course .You can work with some
of the best qualified trainers to understand the entire process of CE marking
to be in line with the European directives. This is a three-day course that is
designed to offer students knowledge about marketing products easily. Regulatory,
quality as well as design and development personnel along with manufacturing
and marketing managers as well as Organizations who are creating their own
branded labels can attend the course.
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