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Types of assessment for CE Marking



The directives referred to in this document are known as the New Approach or Global Approach Directives. They are intended to remove technical barriers and harmonise legislation within the different Member States.

Even though each type of product has its own special characteristics that must be reflected in the applicable directive, the European Commission has tried to give each a common structure based on the conformity assessment procedures and fixing of the CE Marking, detailed in the Council Decision 93/465/CEE.


Conformity Assessment Phases

These procedures always establish two phases for conformity assessment:

a. Design assessment (of a prototype or a sample of the product) by way of relevant tests and studies.

b. Production assessment (all product units must continue to comply in the same way as the sample studied in the design assessment phase), through control of production quality, preferably based on ISO 9001.2000 standards.

In addition, the procedure is further broken down into modules relating to the design and production phase, as shown in the diagram below.


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The modules to be followed by the manufacturer are indicated by that established in the directives which apply to the product, although some directives may introduce their own modifications.

While the aim is to facilitate the commercialisation of products, there are some sectors which, due to risks, strategic factors or social repercussions, are subject to an obligatory certification system (class IIb and III health products, telecommunications terminal equipment designed to be connected to public networks, machines in Appendix IV, lifts, etc.), meaning a Notified European Body must be involved.

The consumer sector must also be protected, and this has been taken into account under the New Approach. The essential requirements specified by the directives, as previously indicated, are established in order to protect people, animals, goods or the environment.

Competent Authorities are obliged to oversee the products that are commercialised within their territory, making use of, in the case of detecting non-compliant products, communication mechanisms with other Competent Authorities within the European Union, as established in the directives, with the aim of protecting all EU citizens against defective products.
Member States have established procedures to follow in these cases and, where necessary, will apply the required disciplinary actions.

In this sense, we highlight Law 22/1994, a transposition of the Community Directive 85/374/CEE "Civil liability for damage caused by defective products", establishing a maximum limit of €63,106,270.96 in civil liability damages in the case of death or serious injury caused by a defective product.


Product Manufacturing

As well as testing a sample of the product, it must also be ensured that all production facilities comply with the essential requirements. The directives contain recommendations for implementing quality systems, and this step constitutes an important part of the structure of the New Approach Directives. The conformity assessment/certification systems that appear in the directives are divided into two parts, control of the design and control of the production, and are based on the Council Decision modules 93/465/CEE.

Module A. Internal production control.

Module  B. Type examination.

Module C. Conformity to type.

Module  D. Production quality assurance.

Module  E. Product quality assurance.

Module F. Product verification.

Module G. Unit verification.

Module H. Full quality assurance.

Module B refers only to the design and not the production phase. In the case of module A, the manufacturer is only required to take the necessary measures to ensure that the manufacturing process shows compliance between the products manufactured and the technical documentation (there is also module A2 which includes intervention by a Notified Body).

It is worth highlighting the importance of the production control procedure. Even if a sample complies with all the requirements for a directive, this does not mean the manufacturer is exempt from liability regarding possible deviations that may appear in other units of the same product.