Sherpa Product Certification

European Certification

What is the European Certification or European Conformity?

In order to legally sell a product within the European Union a manufacturer, importer or distributor must guarantee that his product is safe and meets all safety standards imposed by the European Union. These actors have to make relevant test to ensure that their products meet these mandatory requirements imposed by the European Union and, if applicable,  the corresponding national legislation. They must elaborate the regulatory technical documentation and keep it available to the relevant authorities. They must draft the Declaration of Conformity and label their products according to the applicable legislation. They must report their properties, content, possible warnings and known risks as well as include the CE Mark logotype (if applicable). This process is known as CE Marking, European certification , CE Certificate or European Conformity Evaluation.

Products that have printed CE Mark Logotype must comply with European regulations on safety and environmental and only when the products fully comply with these regulations can be marketed in the European Economic Area (EEA).

The European Union carries out constant checks through the market surveillance authorities. When it is detected that a product does not meet the minimum conditions established safety, the responsible for marketing the product must organize a recall of dangerous products already supplied to consumers, withdraw them from market (product recall) and assume all associated costs, generally including an administrative sanction whose amount varies depending on the product, sector and type of non-compliance detected.

European Certification in 6 steps

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

  1. Determine European Directives that apply to the product.
  2. Find essential requirements.
  3. Check if the 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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More about CE Marking

Our Specialities

Sherpa provides complete european certification or specific  assistance at any stage during product certification duties, facilitating correct understanding of its legal requirements and its aplicable directives.

Click on each category for more information
machine
Machinery and Installations (MD)

Machinery Directive 2006/42/EC

chip
Electronic Equipment (EMC)

EMC Directive 2014/30/EU

medic
Medical Devices (MDD)

Medical Devices Directive 93/42/EEC.

atex
ATEX

ATEX Directive 2014/34/EU

pressure
Pressure Equipment (PED)

Pressure Equip. Directive 2014/68/EU

toy
Toys

Toys Safety Directive 2009/48/EC

glove
Personal Protective Equipment (PPE)

PPE Regulation ion 2016/425/EU

antena
Radio Equipment (RED)

Radio Equipment Directive 2014/53/EU

plug
Electrical Equipment (LVD)

Low Voltage Directive 2014/35/EU

wall
Construction Products (CPR)

Construction Products CPR 305/2011

rohs
Restriction of Hazardous Substances (RoHS)

RoHS Directive 2011/65/EU

other
Other (GPSD)

General Product Safety Directive 2001/95/EC

Sherpa Certification Company is your European Certification Expert

The certification process varies depending 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 must comply with the applicable regulations. Sherpa Product Certification is an European Certification specialists and we will guide you through all the steps and if required, we will carry out the entire process for you to implement the CE marking on your products.

Identify the European Normative applicable to your product

Product classification according to the definitions included in current EU Directives and Regulations. We determine, based on this classification, which directions and regulations should be considered in order to market the product in the European market.

Extract and classify Legal Requirement

Determine legal requirements imposed by regulations are applicable to your particular product. We will tell you which of these requirements your product must meet and we will help you achieve those objectives.

Evaluate Product Conformity

To know if a product meets certain requirements specified in the regulations, it must pass a conformity assessment. Sherpa Product Certification will evaluate your product according to the essential requirements previously identified, In case the product do not meet the minimum requirements, we will indicate the needed changes in your product to fulfil them.

Tests by Acredited Laboratories

During a conformity assessment it is necessary to verify that the technical and functional aspects of the product are in accordance with the safety and compatibility requirements established by current regulations. To guarantee and demonstrate these requirements, it is necessary to submit the product to laboratory tests or tests by accredited laboratories for the nature of the product. Sherpa Product Certification will determine what tests are required and submit the products to those tests to verify their compliance.

Management of Notified Bodies

In most cases the evaluation can be carried out by the manufacturer itself, however, certain products, according to regulations, must be evaluated by a Notified Body that acts as the competent authority, which is designated by the European Commission for that purpose. If your product must be evaluated by an authority, we will indicate to which Accredited Body address to perform this conformity assessment according to the nature of your product. In this case Sherpa Product Certification can manage all procedures on your behalf.

Write Product Declaration of Conformity and perform the CE Marking

Products marketed in European territory must have a Declaration of Conformity in which it is indicated with which regulations and directives the product complies. Sherpa Product Certification will prepare all the necessary documentation and draft the Declaration of Conformity as well as guide you in the process of fixing the CE marking.

Write and maintain Product Technical Documentation

Each regulation indicates what content should be included in the technical documentation of a product. Sherpa Product Certification will perform a requirements analysis according to the applicable Directive or Regulation to determine if current documentation meets these requirements. In case of having incomplete or incorrect technical documentation, Sherpa Product Certification will indicate how to complete or modify this documentation to adapt it to the requirements identified in regulations. In case of not having technical documentation, Sherpa Product Certification will guide you from the beginning indicating all required steps to fulfill all content and format requirements.

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¿How can we help you?
  • Complete European Certification and CE Marking for your products
  • Complete assessment for manufacturers, importers or exporters regarding product legislation
  • General inquiries about CE Marking
  • Product analysis & classification in accordance with its applicable normative scheme and region
  • Determine which regulations and directives apply to a product at an specific region
  • Customs Tariff analysis for products and materials.
  • Perform product conformity test according EN, ISO, IEC among others
  • Product Market Access complete assistance
  • Determine corrections and authenticity about specific Product Certifications.
  • Determine manufacturer's, importer's and distributores responsabilities regarding product legislation.
  • European Authorised Representatives Services
  • Write and validate product's Tecnical Documentation and Declaration of Conformity
  • Perform Risk Analysis
  • Packaging and labeling verification according to its applicable normative
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ABOUT SHERPA

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.

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