Responsibilities of the Manufacturer and Importer where CE marking applies

Where manufacturers, importers or distributers have reason to believe that their product is not in compliance with the Declaration of Performance or not in compliance with other requirements of the Construction Products Regulation Immediately, they should take corrective measures, including if necessary withdrawing or recalling the product. In addition, where the product represents a safety risk then the competent national authority must be informed.

Manufacturers, importers or distributors should give details of the non-compliance and of any required corrective measures undertaken and must collaborate with and give any appropriate information and documentation on request.

The manufacturer is responsible for the CE Marking, if the manufacturer is not located within the European Economic Area (EEA), there must be a responsible party authorized by the manufacturer with the EEA. This responsible party who is authorized by manufacturer must have access to the technical file if there are questions from authorities or surveillance bodies.

The authorized responsible third party can be an Authorised Representative, the importer or distributor who can be authorized to take on this responsibility. It is important that the importer is capable to present the surveillance bodies with an EC Declaration of Conformity and have access to the Technical File. This importer has the responsibility for if the manufacturer is not located within the European Community and if he has not appointed a third party such as an Authorised Representative in Europe.

Responsibilities of the manufacturer

The manufacturer is any natural or legal person who manufactures a product or has a product designed or manufactured, and places it on the market under his own trademark. The responsibilities of the manufacturer apply also to any natural or legal person who assembles, packs, processes or labels ready-made products and places them on the market under his own trademark.

Further, the responsibility of the manufacturer is placed on any person who changes the considered use of a product in such a way that different essential will become applicable, or substantially modified, or further re-builds a product.

Also the manufacturer is responsible for designing and manufacturing the product in conforming to essential or other legal requirements laid down by the relevant European Union harmonisation legislation and for carrying out conformity assessment in accordance with the procedure laid down by the Union harmonisation legislation.

If an importer modifies a product to the expanse that the deliberated use with the applicable requirements may be affected or supplies the product under his trademark. Accordingly, he must make sure that the product complies with the applicable European Union harmonisation regulations and that the appropriate conformity assessment procedure has been carried out so that the CE marking can be legally affixed to the product.

Responsibilities of the importer

The importer must make sure that the manufacturer not build up in the European Union has correctly fulfilled his obligations. The importer is not a simple re-seller of products, but has a key role to play in undertaking the compliance of imported products.

Importers may only place construction products on the market that only perceive with the Construction Products Regulation. They will make sure that the manufacturer has hold up a Declaration of Performance and attached the CE mark. The importer should check that the Declaration of Performance has been slug in accordance with the model that the product bears a mark allowing its identification and that of the manufacturer.

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Why CE Marking for Inventors And Small Businesses?

The small inventors and small businesses usually come up with documents and obstacles to the success of the market for their product. One of these obstacles to overcoming is that they must be forced to receive the CE mark for the product if it is sold together with the European Union. The CE mark means in general terms that the product is safe to use when it is used as such. But the approach to CE marking and also the burden of proof of product correspondence or otherwise is determined in clearly alternative ways with differing levels of business risk.

The most recognized and earned way of obtaining the CE marking is external certification. Affiliated companies are safe with international standards which are generally considered EU laws and therefore are confident that the product will or will not guarantee it with the requirements of the CE marking standard. The manufacturer will thus place confidence in this as clear proof of correspondence wherever a CE mark is awarded by an accredited certification body. This additionally offers the smallest amount business risk as skilled accredited firms have determined compliance. But the money burden to little businesses will become important.

The other possibility hospitable the lone artificer or little business is to self-declare CE correspondence. From a legal point of view, the burden of proof on self-signed correspondence is currently certified by the EU, since any legal proceedings should lead to accidents involving the product. This can be seen as the best risk that some may not want. However, this may seem to be a high-risk strategy for others, even for the price of an invention or a new product, a step necessary to demonstrate the potential of sales. goods, perhaps through the study of sales or exploration of distribution channels. However, with the right thought and documentation of support there is no reason why this is not an economically effective course, if not more risky.

As with several alternative business documents, their absence is considered a legal violation, and automatic discovery was found guilty. Declaring yourself and the product of the CE marking without a thorough technical test would be a commercial suicide and definitely not recommended here. Therefore, it is important that full and correct technical documentation supports the self-declaration, which this document remains pending consideration, to create a legitimate request.

Many approved CE marking products are sold throughout the EU and are inherently endorsed by the inventors or the same company for small businesses. Given the intense technical guidance to support the initial sale of goods, the choice to seek the right to vote under the EU’s external compliance law becomes apparent when sales support these investments.

 

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How You Benefit From Having CE Marking on Your Products?

The CE Mark is a kind of commercial passport for the European market. It allows the manufacturer to freely distribute their product in the European Economic Area (EEA).

If the new directives of product apply to your products; and you want to continue to export to the European market (or introduce new products), then CE Marking will be crucial to your success. The big advantage for manufacturers is that there is now only one set of requirements and procedures to be met during the design and production of a product for the entire EEA.

The different and conflicting national regulations are eliminated. As a result, the product no longer has to adapt to the specific needs of the different member states of the EEA. Besides with the CE Marking, claims for damages will also be limited, because a safe product must be put on the market with good instructions for the user and with safety regulations. This also means that the product is safer for the consumer.

Benefits of CE Marking

  • Indicates that the product can be legally sold within the European Union (EU) and the European Free Trade Area (EFTA).
  • Ensures the product can move freely throughout the European single market.
  • Indicates to customers that the product meets minimum safety standards and therefore has a minimum level of quality.
  • You have unrestricted trade within the European Economic Area because there are no more different national trade barriers for products.
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How CE Mark Certification Approaches to Product as per EU Directives

The CE marking is mandatory according to new approach directives. Many products are covered by these guidelines, and are placed on the market in the EU, some have to carry the CE marking – it is a legal requirement. The CE mark is the manufacturer’s demand that the product meets all the essential requirements of the relevant European directives.

The CE marking Certification, which is affixed to a product or its packaging, is considered proof that a product meets the requirements of the harmonized European standard or directive. Europe is a competitive market, but the price is easier to access than ever before. This is why many Indian exporters, especially small and medium enterprises, avoid it because the technical requirements for entry seem too complicated, too difficult or too expensive. Indian manufacturers who have successfully accessed the European market know that it is worth knowing the European system.

The European Commission, which administers the program, describes the CE mark as a passport for products to be sold freely in the EU internal market. It is required by law if the product falls within one of the new approach directives. It is not a quality mark or a brand for consumers. For the authorities of the Member States, it is a sign visible to those authorities that your product is in accordance with the New Approach Directives. All manufacturers are required to affix the CE marking to products covered by the New Approach Directives. CE marking on a product indicates to all the authorities that the product complies with the essential health and safety requirements of all directives applicable to the product.

How to Acquire the CE Mark Certification

There are a series of steps for CE Mark Certification described below. Depending on your product and the nature of the risks it presents, there are several alternatives also noted that may apply to your situation.

  • Determine whether the guidelines applicable to your product. If more than one of you will comply with all.
  • Determine the extent to which your product complies with the essential requirements for the design and manufacture of the directive (s) that is applicable.
  • Select the product standards and test methods for your product and select an independent laboratory test if the product must be done outside.
  • Affix the CE marking on your product. There are specific rules to follow in the CE marking. These rules relate to the size and location of the marking, CE marking of products, packaging and material or documents shipped with the product CE, and specific limits on when and who is authorized to affix the CE marking CE.

 

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Learn about Preparing CE Technical File for CE Mark Certification

The CE Marking is an indication that the product complies with the essential requirements of applicable directives and that the product was subjected to procedures for conformity assessment as provided in the guidelines. It allows the product to be freely marketed within the European directives accredited conformity assessment. CE Marking only applies to products regulated by European health, safety and environmental protection legislation.

Sample of CE Technical FileCE technical file for product is a quality symbol or a marketing tool. CE marking is the manufacturer’s declaration and acceptance by European accreditation body that the product complies with all applicable directives. Sample of CE technical file is the only indication that signifies conformity to all obligations incumbent on manufacturers for the product as required by the applicable directives providing for its affixing. CE technical file replaces all other requisite conformity markings having the same meaning in existence before harmonization took place.

Requirements for CE technical file for product certification range from a manufacturer’s declaration, up to mandatory full Notified Body assessment of the product and manufacturing controls. The requirements for CE technical file differ across all the Directives and may also vary for different products within a Directive. Depending on the product, CE technical file can be as simple as formulating a technical file, or as complex as having to send products to regular independent basis. The Sample CE Technical File is helpful for Machine, Pressure, EMC, LVD, Medical device and other applicable industry products. Our sample CE Technical file packages are competitively priced and effectively meet the global customer needs for product certification.

Steps for achieving CE Mark Certification for your product:

  • Identify the directive(s) and harmonized standards applicable to the product
  • Verify the product-specific requirements
  • Identify whether an independent conformity assessment of a notified body is required
  • Test the product and verify compliance
  • Prepare and keep available the required technical documentation
  • Affixation of the CE marking to your product and EC Declaration of Conformity.
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Who is Responsible for CE Marking?

The CE marking requirements cover distinctive aspects of the design, manufacture and distribution of a product. Generally, several companies are involved in the design, production, distribution and marketing of products. The contribution of each of these links in the production chain and the distribution chain can affect the CE conformity of a product. For example, a product can be designed according to the requirements, but it may not meet at the end since there is a deviation of the project during the production phase. Or an electronic component may have been tested and approved for electromagnetic interference requirements, but may begin to cause illegal disturbances if not installed correctly. This raises the question of who is responsible for the CE marking

The European Directive on CE Marking aims to make a person primarily responsible for and responsible for compliance with the CE. The way to identify that responsible person is quite exclusive of these directives. The directives are expected to stipulate that the “manufacturer” is responsible for the CE marking. But they define two moments at the moment when the responsibility begins for CE

In accordance with the CE Directives, a product must comply with the requirements of the CE and have a CE mark from the moment it is:

  • Introduced into the Community market for the first time;
  • Commissioning on the Community market for the first time.

Putting into the market is the initial action of making a product available for the first time, for a fee or free of charge. Commissioning takes place at the time of first use in the EEA by the end user.

You can ask why the European legislator chose this construction to establish responsibility. The answer is for reasons of clarity and flexibility to be able to deal with all the different cases you may encounter in practice.

Therefore, the conclusion is that there could be a “person” who has the ultimate responsibility for compliance with the CE. However, this person cannot ensure compliance with the CE without the help of all parties involved in the design, production and distribution chain. And so we see specifically that CE marking requirements are increasingly becoming part of the agreements and contracts between these parties.

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What is the Objective of CE Marking?

The European CE Mark Certification procedure was created mainly for:

  1. To approve all the various national consumer and industrial product standards in the European Member States in order to promote the Single Market;
  2. Bring about cost savings for producers;
  3. Improve product safety;
  4. Supply public bodies with a uniform procedure that can be checked.

CE Mark CertificationEarlier, individual Member States of European Union have set up product requirements and test procedures in Europe. This meant that, for example, companies that want to sell their products on the European market, and sometimes have to deal with more than ten different technical requirements and procedures for a single product. The existence of all the different national laws was in contravention of the European Union’s Single Market Implementation objectives, which will be the free distribution of products (as well as the free circulation of persons, services and capital).

All the different product requirements have brought costs to manufacturers. By guidance of the CE Marking Directives or ‘New Approach’ Directives, the measures have been optimized by defining European requirements, the harmonization of national legislation and directives, standards and mutual recognition of the technical standards, tests methods (compliance tests) and test laboratories, so that producers no longer need to adapt their products to the different markets.

During the reconciliation process, the safety level of all products was created and raised. In most European countries, health and safety has been subject to directives for many years, but the level of safety has not always been satisfactory

With the help of conformity assessment procedures, authorities can ensure that products placed on the market meet the requirements specified in the directives. The CE Marking is consequently largely for the benefit of the authorities. However, safe products are also necessary for the end user in the work or consumer environment.

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