CE Marking

26 diciembre, 2018

CE Certificate

The CE marking is a mark that meets the objective of certifying the proper adaptation of the characteristics of a product to the applicable standards based on their specific characteristics. It is essential that almost any product is certified by the CE certificate before being released to the market to ensure that it will not harm its users, and without this stamp there is a risk of suffering considerable administrative sanctions (in addition to severe commercial restrictions).

🇪🇺 What product do you want to certify with CE mark?

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Why work with Omologic?

Engineers specialized in CE Certifications

You will know all the regulations that apply to your product

We avoid large costs and production failures

We process everything for the test of your product

And now also … We finance your project with Banco Sabadell

Omologic has a collaboration agreement with Banco Sabadell Startups to finance the obtaining of your CE Marking. With Omologic you can finance your CE Marking consulting service, manufacturing and prototyping of your product, implementation of Quality System in the factory and laboratory tests of your product.

Opinion of our clients

Raquel Serrano – Fiixit: “Thanks to Omologic I was able to achieve the CE Marking of my product (immobilization splints by 3D printing). I have always received their support, advice and they have clarified all my doubts about the marketing approach of my product.”

Victor Tienda – BIC Euronova: ‘The Conferences on CE Marking are very important so that our entrepreneurs do not make mistakes in their beginnings when it comes to sell their products in Europe. That’s why we have no hesitation about trusting Omologic.”

What do you get with the CE Marking?

The CE Mark opens the doors to the European market

The CE is mandatory for most articles.

Differentiate your product from others with the CE Marking

Quality and safety guarantee for your client

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CONSULTING REFERENCE IN CE MARKING

Omologic is a specialized consulting company and internationally referenced in the CE marking of all types of products. The object of Omologic is to advise our customers technically and legally to achieve the mandatory compliance of the CE Marking in products such as Electronic Devices, Construction Products, Industrial Machinery, Agricultural Appliances, Pressure Apparatus, Boilers…

We work so that you can sell your product with all the guarantees that the CE Marking provides to the market.

We have a technical, engineer and highly qualified team in charge of processing all your documentation so you can certify your products. Our priority is to be close with you and your product. We inform, train and prepare everything so that you can obtain the CE Marking and know the legal requirements that affect your product. That is our commitment. Achieve that you can reach Europe with your product through the CE Marking and its commercialization guarantees.

Our customer orientation and our vocation for innovation has helped us to consolidate ourselves as leaders in CE Marking Consulting.

WE OBTAIN THE CE CERTIFICATION OF YOUR PRODUCTS

At Omologic we help you obtain the CE Marking of your product supporting you in any phase of your process. We have all the professional and technical support to get your certification. We give you the guidelines so that you can sell your product in Europe without administrative sanctions or commercial restrictions.

Starting to work with the CE Marking of your product before you start manufacturing allows us to save costs and production errors.

WE FORM YOUR TEAM IN CE MARKING

Omologic, in support of the innovative development of the entrepreneurial community, host  training days on CE marking in centres such as Technology Parks, Business Centres specialized in R + D + i, Universities and Entrepreneurship Forums about the CE Mark and the European commercialization of all types of products. At present, we support numerous entrepreneurial projects in their certification and European distribution.

We are proud to be an active member of the research, innovation and entrepreneurship cores and to collaborate so that the best solutions reach the market.

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🇪🇺 STILL WITH DOUBTS ABOUT MARKING CE?

WHAT IS THE CE MARKING OR CE MARK?

The CE Marking of a product is an element of accreditation at European level that provides information to the user about both health and safety since its approval implies compliance with all legal and technical requirements that are required, in this regard.

The CE Marking as a badge is placed on products that meet all marketing requirements in the European Union. The CE certificate is, today, the passport for the trade of the product within the countries of the European Union.

Achieving the CE Marking supposes an endorsement for any product in its commercialization. Consumers and other industries value the CE Seal when selecting which item to purchase or add to their value chain since it provides security and guarantees that the product has successfully passed all the standards imposed by the European market. We could say that, the CE Marking or CE Certificate of the products constitutes a declaration that the product:

  • Complies with all community directives.
  • Guarantees user protection
  • He has passed numerous tests in production and testing processes.
  • All established procedures have been correctly performed to evaluate such compliance.

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WHAT PRODUCTS SHOULD BEAR CE MARKING?

Is it mandatory that all products bear CE Marking? The CE marking is mandatory for all products affected by the scope of application of the directives that establish their placement for distribution on the EU market (European Union).

Taking this into account, the products that must be marked CE are:

  • New products both manufactured in member states of the European Union and in third countries that will be distributed and/or sold in Europe.
  • Used and / or second-hand products imported from third countries.
  • Substantially modified products that are governed by the directives as if they were new products.

    An engineer will study the characteristics of the product to determine if its CE Mark or other type of documentation is necessary.

In some cases, certain articles are excluded, leaving the application of the CE certification free even if the directive is applied to the product. These products may be subject to free movement if their distribution is justified and accompanied by a declaration of compliance. Also in the case that the product has been manufactured in accordance with good engineering practices, have a certificate of conformity or bear the name of the manufacturer and an indication of maximum capacity.

WHAT SHAPE DOES THE CE MARKING HAVE AND HOW IS THE CE MARK PLACED?

  • The CE marking is placed on the product or descriptive plate thereof.
  • Reduced size in packaging or accompanying documents that accompany the product.
  • It should always show a visible, readable and must be indelible.

WHO PLACES THE CE MARKING?

The responsibility of correctly marking a product with its CE Certificate falls on different agents to a greater or lesser extent.

These are, essentially:

  • Manufacturer of the product: It has exclusive and absolute responsibility for the conformity of the product with respect to the directives that are applicable to it.
  • Authorized Representative: The authorized representative is the person established in the community and designated by the manufacturer to act on their behalf.
  • Importer: Is responsible for the distribution of the product from a third country. The responsibility for the CE marking falls on it if the product was not manufactured in Europe by a European producer or if an authorized representative was available.
  • Distributor: This agent is the one who carries out the commercial activity in the community market on the product. The distributor may be required to demonstrate the conformity of the product with respect to the Directives that apply to it.

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🇪🇺 OTHER FREQUENTLY ASKED QUESTIONS ABOUT CE MARKING

IS THE CE MARKING COMPULSORY?

Marcado CE

Marking CE is totally indispensable for any product sold or distributed that is regulated by new approach community directives.

HOW IS THE CONSUMER GUARANTEED WITH THIS MARKING?

The consumer will have the guarantee that the product with CE marking complies with all EU legislation, quality and safety. According to European legislation, EU countries cannot limit the access and sale of a product that contains the corresponding CE Mark.

HOW DO I GET THE CE MARKING FOR MY PRODUCT?

At OMOLOGIC, we have one of the most qualified technical departments in CE Marking in the country. We will evaluate your case and advise you on all the procedures for your product.

We advise you to get in touch with us as soon as possible so that you know the legal requirements of the product before its manufacture, to be able to integrate the necessary measures from the beginning and not have to change the design of your product at an advanced stage of production.

Specialists at your disposal to help you legalize your product.

WHAT IS THE EVALUATION OF PRODUCT CONFORMITY?

The evaluation of the conformity of a product is a procedure by which it is indicated that the products meet the essential requirements contemplated in the current directives. For this, it may be necessary to carry out CE examinations / audits by the Notified Organization.

In addition, it may be necessary to carry out a Factory Production Control Manual.

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WHAT IS A DECLARATION OF CONFORMITY?

Declaración de conformidad marcado CE

The CE Mark Declaration of conformity is the document by which the manufacturer declares that the product that manufactures and sells under its name complies with current regulations.

WHO SHOULD SIGN THE DECLARATION OF CONFORMITY?

Someone with authority in the company: the owner, manager or any worker with a higher position in the company.

This Declaration must be kept by the manufacturer in case it is required by any competent Administration and in all cases a copy will be attached along with the product.

IS IT MANDATORY TO REQUEST THE CE MARKING FOR AN IMPORTED PRODUCT?

Yes, the CE is mandatory for imported products and you must take special care if the product is imported from a country that is not a member of the European Economic Area (EEA).

WHAT DOCUMENTATION IS NECESSARY TO OBTAIN THE CE MARKING FOR MY IMPORTED PRODUCT?

To be placed on the market in the EEA, the same procedures must be carried out as in the case of manufacturing the product, i.e. at least a technical construction file, an instruction manual, EC declaration of conformity and, depending on the product, will be required laboratory tests of the product in a Notified Organization, a Factory Production Control Manual or even pass audits. In Omologic we elaborate all the necessary documents for the CE Marking of your imported product.

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WHO IS THE RESPONSIBLE IF A PRODUCT DOES NOT HAVE CE MARKING?

The manufacturer is responsible for the certification procedures and, where appropriate, certification of product compliance. And if you have it, but it is not in compliance with current regulations, it is as if you did not have it.

Because of this, in Omologic we guarantee the compliance of the product with the essential requirements of the application Directives, as well as, we elaborate the necessary technical documentation.

CAN I BE FINED IF MY PRODUCT LACKS CE MARKING OR THE CE SEAL HAS BEEN INCORRECTLY POSTED?

Yes, each European country sets administrative and criminal penalties for the manufacturers and / or merchants of the product in these cases. Depending on the severity of the infraction, the penalties can range from economic fines to prison sentences. Only in the case of a minor infringement that does not present an imminent risk to safety, the manufacturer may modify the product to ensure that it complies with current legislation.

SHOULD I MAKE THE CE MARKING OF MACHINES FOR OWN USE?

Yes. A similar process must be carried out as that of a mass production product. Safety must reach everyone as basic as the end of the product.

IN WHAT COUNTRIES CAN I MARKET MY PRODUCT?

By adding CE certification to a product, the manufacturer declares, under its sole responsibility, the conformity of said product with all the legal requirements required to achieve the CE marking and ensures the validity of the product to be sold throughout the European Economic Area (EEA, the 27 EU Member States and EFTA countries Iceland, Norway, Liechtenstein), as well as in Turkey. This also applies to products manufactured in third countries that are sold in the EEA and Turkey.

CONTACTA CON NOSOTROS

At Omologic we offer you a specialized consultancy in CE Marking, through which you will be able to adapt your product to the applicable legislation according to the established standards. Avoid administrative sanctions and commercial restrictions. Contact us.

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