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ce marking Certification : Consultants in SRI LANKA

No matter where we want to market our products, it will need to meet some kind of established standard which could verify that the products are safe to use. Countries all over the world have sought different means to certify products accordingly. In European countries, it’s the CE certification. The initials “CE” stand for “Conformite Europeene” which stands for “European Conformity”.

The said mark on the product stands for compliance with the applicable European standards. The above mark creates a market of the product in around 30 or more European countries that are formally the part of EEA (European Economic Area). Prior to the creation of the European Union, every country posses its own technical requirements for different products. As it was difficult for the manufacturer to comply with all the conformity assessment procedures, export was being restricted only to selected countries.

However, with the formation of European Union, subsequent harmonization of laws, standards and conformity assessment procedures change the business scenario. CE marking is mandatory in the European market. It doesn’t define quality but portrays that the product is safe and eligible to be distributed in European markets. It also indicates to the European government that the products can be legally placed in their market. 

There is no complete list of the products that require CE Marking. It is the manufacturer’s responsibility to find out if a product falls under the CE Marking Directive requirements. The “New Approach Directives” are documents that contain the legislation issued by the European Commission regarding CE Marking Certification. These documents have information on the CE marking requirements that need to be met and the procedures to be followed for a particular product to be CE Mark certified and sold in the EU. 

Third-party testing, systems assessment and technical file assessments can be mandatory, but sometimes the manufacturer’s unverified claim is all that’s asked for. But beware! If you claim your product complies and it doesn’t, you will be prosecuted. Where a Directive requires products and/or systems to be independently tested, certified, or inspected, this must be done by a “Notified Body” or “Competent Body”. 

The CE mark, which is generally fixed to a product or its packaging, is considered general proof that it abides by the requirements of European health, safety and environment protection. It also states that the products have met the requirements of the harmonized standard or directive referring to the European community. It permits free movement of product within the European markets. CE mark affixed in a product should be visible, legible and indelible.

No other symbols that could be confused with the CE Marking can be featured. In addition, as well as affixing the CE Marking, the manufacturer must have the following documents available for ten years from the date of commercialization of the latest device:-

  • Declaration of Conformity
  • Technical File

In exceptional cases, the DC relating to In Vitro Devices only requires the listed documentation to be held for five years following commercialization of the latest device. The very first step of CE mark compliance is to determine which directives will be applied to the product.

A product may be regulated by more than one directive. Generally, an accompanying document known as Declaration of Conformity specifies which directive(s) or standards are applied to the product. The CE mark on the product is generally affixed by the manufacturer or the authorized representative.

  • The CE marking should be affixed by either only manufacturer or his authorized representative
  • After binding to CE marking the manufacturer should take the responsibility for fulfilling the legislation requirements stated in the conformity
  • The CE marking should be affixed only to the product for which its affixing is provided for and not any other product
  • Affixing of other markings which mislead about the product CE marking should be completely prohibited
  • The CE marking shall be the only product marking affixed on the product

Member States shall ensure lawful and ethical implementation of results avoiding the unethical use of marking and taking appropriate action against the improper use of the CE marking.

  • It facilitates the entry of your product into the European Union (EU) and European free trade association (EFTA) markets.
  • It’s also a confirmation that the products are safe and more reliable; therefore reducing the risk of customer dissatisfaction.
  • The quality of the product is also enhanced keeping in mind the requirements of the approach directives of CE markings.
  • International recognition is achieved by the product.
  • It also reduces the damage claims and liability premiums of the product by adhering to the CE mark norms and regulations.
  • Lack of expert knowledge and guidance for the proper understanding of the directives and corresponding implementation results for fake marking by many industries.
  • Due to improper training and rightful education provided to the employees often leads to failure in CE marking process.
  • Inappropriate knowledge of the documentation process often adds extra pressure and burden for most industries diverting their focus from the goal.
  • Due to the lack of continuous monitoring and controlling of different process, organizations fail to achieve the certification.
  • Auditing, Training and improving quality can cost you more than you can input, which makes most of the organization to step out of the process.

How Ascent can help you?

  • Our expert knowledge along different industry experience of more than 18 years gives an edge over other consultants to guide you properly during the achievement of right CE marking directive.
  • Our training modules are conceptualized as per the industry requirement specific to the needs of the organization providing complete understanding and proper training to the personnel’s that can solve CE marking related issues easily.
  • We will guide you throughout the entire CE marking compliance and implementation till achievement of certification.
  • Our business profile analysis process undertaken before start of any project makes sure to utilize the existing resources and documentation thus ensuring no repeats.
  • Our expertise in the given sector will provide you with proper budget knowledge of the project beforehand without you paying any additional expenses afterwards.
  • Our stringent audit methods implemented during the internal audit ensures no failures during the certification audit.
  • Our 24X7 customer support cater the needs of its customers all over the world. This gives you ample opportunity to demand our services even in the odd hours and holidays.

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