Dynamic Strategies

Management is efficiency in climbing the ladder of success; leadership determines whether the ladder is leaning against the right wall. - Stephen Covey.

CE Marking: Passport for entry in Europe

Abstract

CE Marking

CE Marking The initials “CE” stand for Communauté Européen, which is French for "European Conformity”. The CE Mark, which is affixed to a product or its packaging, is considered proof that a product has met the requirements of the harmonized European standard, or directive.

The CE Mark, which is affixed to a product or its packaging, is considered proof that a product has met the requirements of the harmonized European standard, or directive

The CE Marking is mandatory for the offerings to be placed in European Union market. CE ( Conformite Europene / European Conformity) directive comply essential with health, safety and environment requirements and is independent of product quality requirements.

If you want to trade in the EU, CE-marking is a mandatory conformity mark required for a wide variety of products. CE-marking indicates that your products comply with stringent EU product safety directives. However, achieving compliance can be a complex process. As a notified body for nearly all EU product safety directives, our CE-marking conformity assessment services provide you with the expertise you need to achieve compliance.

WHY USE CE-MARKING CONFORMITY ASSESSMENT FROM Dynamic Strategies?

Whether you need assistance for the entire process or guidance for certain parts, we can help you:

Does my product need CE Marking?

CE Marking is most probably required if you export to the 27 European Union (EU) and 3 European Free Trade Association (EFTA) member states the following 20 groups of products –

CE Marking Derivatives:

  • 2006/42/EC Machinery Derivative: The majority of the Directives that require CE marking cover the safety of the product. In the case of machinery, the principal Directive is the Machinery Directive (2006/42/EC). Since many machines contain electrical components or functions, the Low Voltage Directive and the EMC Directive may also be applicable and both of these directives contain additional requirements, which must be satisfied before CE marking can be applied.

  • 305/2011/EU Construction Products Derivative (CPR): The CE marking indicates that a construction product is in conformity with its declared performance and that it has been assessed according to a harmonized European standard or a European Technical Assessment has been issued for it.

  • 93/42/EEC Medical Devices Derivative: Directive which was published about manufacture of medical devices, defined that which products are evaluated within the scope of directive, responsibilities of manufacturers and requirements before being released the product to the market

    More clearly, what is the purpose of Medical Device Directive?

    • Define the conditions required to meet before being released medical devices to market

    • Establish the conformity assessment procedures according to the device classifications

    • Report existing mechanisms to national authorities for maintaining the monitoring and public health

    If you would like to release medical device to European Union Member Countries market, the product should meet the essential requirements of Medical Devices Directive, MDD 93/42/EEC + 2007/47/EC Harmonized standards (For example EN EMC 60601-1-2:2001 and for electric security as EN 60601-1)

  • 2014/33/EU Lifts and Safety Components of Lifts Derivative (95/16/EC Lift Derivative): The lifts and safety components of Lifts Directive aims to ensure that lifts and their safety components are produced to comply to the essential health and safety requirements.

    The essential health and safety requirements have to be met for lifts and safety components of lifts. The essential health and safety requirements are divided in general requirements, risks for persons in- and outside the carrier, other risks, marking and instructions. The general requirements are then again subdivided in the following requirements;

    • Application of the requirements of the Machinery Directive 2006/42/EC;

    • Requirements for carriers;

    • Requirements for means of supervision and means of support;

    • Requirements for the control of loading;

    • Requirements for the machinery;

    • Requirements for the controls.

We offer CE Marking Certification throughout India

CE marking does not indicate that a product was made in the EEA, but merely states that the product is assessed before being placed on the market and thus satisfies the legislative requirements (e.g. a harmonized level of safety) to be sold there. It means that the manufacturer has verified that the product complies with all relevant essential requirements (e.g. safety, health , environmental protection requirements) of the applicable directive(s) – or, if stipulated in the directive(s), has had it examined by a notified.

Our Approach

One of the best ways to achieve success of a new product is to give it the best possible start, with care and attention at every stage. At Dynamic Strategies Global Solutions Pvt. Ltd., we can assist with the entire life cycle of a product from design and development, supply and production, distribution and delivery, to retail distribution and even final dismantling or destruction. Complying with the CE Marking is a critical issue when looking to launch your product on the global marketplace. Understanding the myriad of the regulation that affect your product in your target market is a key to success. Our assessment process begins with the understanding where product(s) is to be marketed, who will use the product, what are your quality expectations?

Benefits

CE marking on a product:

Services

Steps to ISO/IEC 14001 certification

ISO 14000 is a family of standards related to environmental management that exists to help organizations (a) minimize how their operations (processes etc.) negatively affect the environment (i.e. cause adverse changes to air, water, or land); (b) comply with applicable laws, regulations, and other environmentally oriented requirements, and (c) continually improve in the above.

ISO 14000 is similar to ISO 9000 quality management in that both pertain to the process of how a product is produced, rather than to the product itself.

ISO 14001 is known as a generic management system standard, meaning that it is relevant to any organization seeking to improve and manage resources more effectively. This includes:

  • Single site to large multi-national companies

  • High risk companies to low risk service organizations

  • Manufacturing, process and the service industries; including local governments

  • All industry sectors including public and private sectors

  • Original equipment manufacturers and their suppliers.