What is CE marking and What are the steps Involve in CE Mark Process

Posted by Ascent World on May 21st, 2018

Many goods sold throughout the European, Indian and other countries economic area should bear the CE Marking. CE Mark is Mandatory for certain category of products/goods such as medical devices, electronic devices, and listed items as defined in EU Directives.

It is a key indicator of product compliance With EU Directives (legislation), enabling free movement of products within the European, Indian and other countries market.

But the main question is how does the product get CE marking, as this is highly critical and time-consuming. There are six necessary steps to follow them to comply with the legal requirement and makes Europe, Indian and other countries markets yours.

Following are the steps in CE mark Certification process

Step 1: Identification of the directives and harmonized standard applicable to the product. there are more than 20 directives setting out the product directories requiring CE marking. It is the manufacturer's responsibility to identify the relevant directive to apply his or her product.

Step 2: Verify the product-specific requirements. it is up to the manufacturers/applicants to ensure that the product complies with the essential requirement of the relevant EU Legislation.  Identify specific Harmonised standards.

Step 3: Identify whether an independent conformity assessment is required from a notified body. each directive covering your product specifies whether an authorized third party must be involved to assesses the conformity necessary for a CE Marking.

Step 4: Test the product and check its conformity as per EU Directives and Harmonised Standards. it is the manufacturers/applicants’ responsibility to test the product properly and check its conformity to EU legislation. One part of the procedure is the Product risk assessment, by applying the relevant harmonized European standards. The Manufacturer / Applicant will be able to fulfill the essential legislative requirements of the directives however the use of the harmonized standard remains either mandatory or voluntary, based on the requirements as from the EU Directives / Legislations.

Step 5: Draw up and keep available the required technical documentation. the manufacturer has to establish the technical documentation required by the directives for the assessment of the conformity of the product to the relevant requirements and for the risk assessment. The technical documentation and the EC declaration of conformity must be presented to the relevant national authorities on request.

Step 6: A fixing of the CE mark on the product and EC  declaration of conformity. The CE Marking must be affixed by the manufacturer, and it must be affix according to its legal format visibly, legibly and indelibly to the product or its data place.