CE Marking for Products

CE Marking - EU Product Directives and Regulations

CE Marking - European Directive 93/68/EEC

The European Directive 93/68/EEC regulates and harmonizes the use of CE Mark logotype and the process of CE Marking for products. This Directive specify its scope of application according to each product category. This Directive is applicable to the integrity of the European Union (EU) and the European Economic Area (EEA) and its only valid for products with respect to which the EU specifications have been introduced.

The certification process varies depending on the type of product, it generally consists of 6 steps and ends with the CE marking fixed on the product. However, certain products do not require the CE marking itself, although they do comply with the applicable regulations. Sherpa Product Certification is specialists in European certification, we will guide you through all the steps and if required, we will carry out the entire process to implement the CE Marking on your products.  Ask our Experts!

Below is guidance information on product directives and categories which Sherpa can assist you in full or in part during the CE Marking process.

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To see a Brief of each Directive click on its Directive's Nº

Machinery (MD)

The Machinery Directive 2006/42 / EC harmonises the safety and health requirements for the design and manufacture of machines at European level. These must meet these requirements before being traded or used.

The aim of this directive is to have safer machines that contribute significantly to reduce accidents and damage to health, in the workplace or in the domestic environment. By fixing the CE marking on these products, the manufacturer or the importer guarantees that they meet the standards stipulated by the European Union in relation to safety, health and the environment.

This directive applies to the following products: machines, interchangeable equipment, safety components, lifting accessories, chains, cables and straps, removable mechanical transmission devices, quasi-machines.


Electrical Equiment - Low Voltage (LVD)

Directive 2014/35/EU for electrical equipment harmonises the safety and health requirements defined by the European Union for the manufacture of electrical material and components in a given voltage range.

The purpose of this Directive is to ensure that electrical equipment marketed in Europe meets the requirements that provide a high level of protection for human health and safety, of pets and goods, in addition to guaranteeing the functioning of the internal market at the same time.

This Directive shall apply to electrical equipment intended to be used with a nominal voltage between 50 and 1 000 V in alternating current and between 75 and 1,500 V in direct current, with the exception of certain materials and phenomena.


Electronic Equipment - Electromagnetic Compatibility (EMC)

EMC Directive 2014/30/EU applies to products that generate a magnetic field of a certain intensity or have some type of immunity for it.

The objective of this directive is to set standards for a complete electromagnetic compatibility between devices and guarantee their correct operation. If the producer or importer marks their products with the CE mark, it ensures that the product meets all the safety requirements included in the EMC directive 2014/30 / EU.

Normally, CE marking on products covered by directive 2014/30 / EU also apply directives such as LVD (Low Voltage Directive) and RoHS.


Construction Products (CPR)

The CPR 305/2011 Regulation establishes the standards and requirements agreed by the European Union for the manufacture of products for construction.

The purpose of this Regulation is to design and execute construction works in a way that does not compromise the safety of people, pets and property or harm the environment . Likewise, minimum requirements for certain construction works are taken into account, such as the climatic, geological and geographical conditions that will influence the entire useful life of the product.


Medical Devices & Sanitary Products (MDD)

Regulation 2017/745/EU & Directive MDD 93/42/EEC harmonise manufacturing standards and requirements established by the European Union for manufacturing medical devices.

The objective of this directive is to guarantee safety and protection for the health of patients, users and others in relation to the use of health devices.

As this is an extensive and critical field in public health, this directive needs to be harmonized in context with others, taking into account pharmaceutical and clinical aspects.


Pressure Equipment (PED)

Directive 2014/68/EU governs the pressure equipment manufacturing standards established by the European Union and manufactured in European territory.

Directive 2014/68/EU rules the manufacturing standards for pressure equipment build in European territory or new /second-hand equipment, imported from a third country. The directive guarantees that the manufacturer or importer takes into account all the basic safety and risk requirements for the use of these products by people or other machines.

This Directive applies to pressure equipment subjected to a maximum permissible pressure PS greater than 0.5 bar. Pressure equipment subjected to a pressure less than or equal to 0.5 bar does not present significant risks and must not be subject to regulation and there are no obstacles to its free circulation in the European Union. It also applies to assemblies made by various parts of pressure equipment assembled to form an integrated and functional unit.

There are pressure equipment that due to their scope of use are governed by other directives needed to be taken into account.


Potentially Explosive Atmospheres (ATEX)

Directive 22014/34/EU harmonises manufacturing standards and establishes the health and safety requirements for equipment and protection systems for use in potentially explosive atmospheres.

This Directive aims to establish the basic and supplementary requirements that must be taken into account for existing or potential hazards. The protection devices and systems must meet one or more of these requirements for their proper functioning or applicable for a use according to the intended use.


Personal Protective Equipment (PPE)

Directive 2016/425/EU harmonizes health and safety requirements for the use of personal protective equipment that protects users.

Manufacturers or importers are responsible for PPE complying with the requirements of this Regulation or Directive to ensure a high level of protection of public interests, such as health and safety, and the protection of users, in addition to ensuring fair competition in the Union market.

The conformity assessment. According to this directive, it is the exclusive obligation of the manufacturer.

Certain products on the market that have a user protection function are excluded from the scope of Directive 89/686/EEC for various reasons.


Toys Safety (TSD)

Directive 2009/48/EC harmonizes and establishes the essential safety requirements for the manufacture and marketing of toys.

Directive 2009/48 / EC harmonises and establishes the essential safety requirements for toys, including special safety requirements in terms of their physical and mechanical properties, flammability, chemical and electrical properties, hygiene and radioactivity.

The aim of this Directive is to harmonize the essential requirements for the safety of toys and to facilitate their commercialization throughout the European Economic Area (EEA).

Keep in mind that toys are also subject to national directives and Directive 2001/95 / EC of the European Parliament on general product safety. This Directive is applied in a complementary way to specific sectoral legislation.

The CE marking indicates the conformity of a toy, it is the visible result of a whole process that includes the evaluation of its conformity throughout the European territory.


Radio Equipment (RED)

Directive 2014/53/EU harmonizes the legislations of the member states of the European Union on the commercialization of radio equipment.

All equipment that intentionally emits or receives radio waves for the purpose of radiocommunication or radiodetermination is subject to this Directive and, consequently, systematically uses the radioelectric spectrum.

The purpose of this Directive is to guarantee the efficient use of the radio spectrum so as to avoid harmful interference and guarantee a level of electromagnetic compatibility suitable for its environment.

Fixed terminal equipment is excluded from this Directive and is regulated by another Directive.


Restriction on the Use of Hazardous Substances (RoHS)

Directive 2011/65/EU establishes rules and restrictions on the use of certain hazardous substances in electrical and electronic equipment.

Directive 2011/65/EU establishes rules and restrictions on the use of certain hazardous substances in electrical and electronic equipment in order to contribute to the protection of human health and the recovery and disposal from the environmental point of view of waste.

This Directive aims to reduce considerably the risks to health and the environment associated with these substances and replace them, as far as possible, with other more environmentally friendly ones.

This Directive is applied together with others according to the scope of the product. These specify specific eco-design requirements for the products in question.


Other - General Product Safety (GPSD)

Directive 2001/95/EC establishes basic safety rules and requirements throughout the European territory for all products placed on the market in the market. European Economic Area (EEA) .

During the use of products, they can present risks to the health and safety of consumers and should be prevented. The purpose of this Directive is for manufacturers and importers to design and manufacture their products taking into account all relevant safety aspects, in particular consumer categories that may be particularly vulnerable to the risks presented by the products in question, such as children and elderly people.

This Directive applies to all products marketed in the European Economic Area (EEA) and depending on the scope of each product there may be more restrictive Directives to be taken into account.

Complete CE Marking and European Certification

Sherpa Product Certification provides a complete European Certification or specific assistance at any stage or during the process of product certification and CE Marking. Our contribution  will  help summarizing and delimitate the framework applicable to your products, facilitating the understanding of standards and its related processes to comply  them.

Certification of products in 6 steps

The process of certification is defined according the category of the product but the basic certification scheme is compounded by this six steps:

  1. Determine European Directives that apply to your product
  2. Find essential requirements for your product
  3. Check if your product requires the intervention of a Notified Body
  4. Evaluate product conformity
  5. Write and maintain product technical documentation
  6. Write product Declaration of Conformity and perform the CE Marking
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Sherpa Product Certification is formed by a group of engineers who are experts in regulation and standardization of products, materials and industrial processes at an international level. Our essence as Sherpas is to help our clients to create lasting value in their business and meet their professional needs. If you need help in the procedures of a certificate or simply need specific information about our services, we are  happy to help you. Hire a Sherpa in your company and forget about legislation and documentation of your products. Our Sherpas certification experts report quickly and efficiently to the needs of our clients when we are most needed.