CE Marking is required for market access of a great number of products to the Member States of the European Union, in Norway, Iceland, Liechtenstein and Turkey.

With our CE Marking services Alura Group aims to provide Clients a one-stop-shop experience. Our services include product review and conformity assessment, training, risk assessment and the compilation of Technical Files required by European law. Our affiliation with European Notified Bodies and accredited testing laboratories allows us to oversee, manage and coordinate the entire CE certification process for our Clients’ products.

1. Compliance Consulting

Typically, a CE marking project starts with determining exactly which CE Directives and European harmonized standards apply, as well as providing the Client with clear insight into the steps involved in the CE certification process. On the basis of our inventory the Client and Alura Group will address the following:

-        Understanding the relationship between CE Marking requirements, safety requirements, and products liability laws

-        Product investigation

-        Implications and requirements of applicable European directives

-        Understanding how to design new, or evaluate existing products in accordance with the guidelines set forth in the EU Directives and standards

-        Method of certification

-        Assessment of available technical documentation and reports

-        Performing and documenting a detailed hazard analysis and risk assessments

-        Completing the Technical File and documentation needed in order to meet EU legal requirements

-        Responsibility and liability issues for the Client in Europe and North America

2. Documentation of Product Compliance: Technical File

The CE Directives require the manufacturer or importer to compile a so-called ‘Technical File’ containing all relevant product compliance information. The Technical File should be kept available for inspection. (Some CE Directives even require the Technical File to be kept in Europe.)

The exact content of the Technical File differs from one product to another. However, typically a Technical File contains drawings, schematics, serial numbers and other means of product identification, test reports and certificates, list of applied standards etc. The Technical File should at any time reflect the current state of the product. This means that the manufacturer (or importer) is responsible to keep the Technical File up to date.

Alura Group helps Clients to compile Technical Files for their products and to meet the specific requirements of the applicable CE Directives in an effective way.

In most cases, compilation of the Technical File is the preparatory step before a product’s testing and certification.

3. Conformity Assessments and Testing

Through its vast network of auditors and test laboratories, Alura Group can offer virtually all tests and assessments required by the CE Marking Directives. Contact us for a quotation.

+ European Regulatory Service

Keeping abreast of regulatory and standards developments in a rapidly changing global business environment is one of the major challenges facing manufacturers and exporters today. Our Clients retain Alura Group as their information source and reference point. We monitor and report on regulatory and standards development relevant to Clients’ products in Europe.

+ Seminars and Training

Alura Group advisors provide lectures, seminars and workshops on CE Marking and regulatory affairs. These sessions are custom-designed for manufacturers and exporters from various industries, trade associations, governmental organizations, legal- and other professionals firms. Seminars and training are also provided on-site.

+ Authorized Representation

For certain product groups, European law requires that non-European based manufacturers and exporters be represented in Europe. It is recommended to appoint a “third party” to act as an authorized representative for regulatory responsibilities, and who is not commercially involved in the sale of the products.

Through its European offices, Alura Group offers easy access to the required Authorized Representative status. We ensure that all of our Clients’ regulatory responsibilities and interests are handled professionally.

Interested in how we can help you in the CE Marking process?

Click to contact us about CE Marking for machinery

Click here to contact us about CE Marking for electrical and electronic products 

Click here to contact us about CE Marking for other types of products