1.- Who is considered the manufacturer under the Directives?
As a general rule, it is the party responsible for the design and manufacture of a product. It may also include anyone who modifies the product’s application or characteristics, and anyone who assembles a unit based on unfinished elements and products, although each directive may have certain specifications.
2.- What level of responsibility is held by manufacturers of components or incomplete products?
It is impossible to give a generic response to this question as it depends on the product and the applicable directives. Some directives only deal with products that are "Simple pressure vessels", while others such as the Construction Products Directive or the Low Voltage Directive cover incomplete products. In addition, the Machinery Directive establishes a number of different procedures depending on whether it is a machine, a safety component, an unfinished machine or one that will be incorporated into another.
3.- What responsibility does replacement of a complex device part imply?
If a worn or defective part is being replaced for an identical one i.e. a simple repair operation that in no way modifies the characteristics of the device, then the product is not deemed as having been altered in terms of compliance with the applicable directives. However, when this change implies a significant modification of the complex device, affecting compliance with arequirement of the directive, the party responsible for the modification will assume responsibility for compliance of the device with the applicable directives.
4.- What responsibility is held by the importer/distributor of a device?
It is firstly important to distinguish between products being put on the market which are made by a manufacturer inside or outside the European Union (EU).
If the product is made by a non-EU manufacturer, the person who commercialises the device in the EU assumes all the responsibilities which would normally fall on the manufacturer or their authorised representative and, therefore, must ensure that the product complies with the essential requirements and submit all the relevant documentation for control purposes, should this be necessary.
If it is made by an EU manufacturer, this system does not apply and responsibility may not be passed to a third party (distributor, user, etc.). This also applies when an authorised EU agent is involved.
5.- What happens if a product fails to comply with all the CE Marking requirements?
The manufacturer uses the CE Marking to indicate that a device complies with the essential requirements established in the applicable Community Directives. Therefore, if products are not compliant, they cannot be put on the market.
For control purposes, the Government sets annual inspection plans (Industry, Consumption, etc.) aimed at establishing fines, removing from the market or blocking the circulation of devices that endanger the safety or health of people, goods or the environment, both in Spain and all other EU Member States.
To get some idea of the scope of responsibilities, we can refer to Law 22/94, of 6th July, which regulates civil liability for damages caused by defective products, and which adapts the provisions of the Directive 85/374/CEE, of 25th July, to national law, aimed at achieving a standardised judicial regime within the EU with regard to such liability.
6.- Are testing standards compulsory?
One of the aims of the Community Directives is to eliminate barriers obstructing the free circulation of products. In this way, each directive provides qualitative guidelines to protect the health and safety of users, goods and the environment. All of this is assessed by way of standards.
It is mandatory to comply with the applicable directive/s in each case, but compliance with standards is voluntary.
The best way of ensuring that we comply with the essential requirements established by the directives, is to use what is known as Harmonised Standards (technical specification created by CEN, CENELEC or ETSI, published in the OJEU, and adopted as a National Regulation by at least one Member State), as this assumes conformity with these essential requirements.
The manufacturer is free to use other means to meet the essential requirements, but must ensure a minimum level of safety equivalent to that established by the harmonised standards.
If these standards are not used, and depending on the directive in question, a Examination Type by a Notified Body may be required.
7.- What is self-certification?
The language of the New Approach refers to an Internal Production Control procedure (Module A DC 93/465/CEE), a concept which generally refers to the term self-certification.
In cases where the applicable directive/s in each case do not require a competent third party to carry out conformity assessment tasks (Notified Body), the manufacturer is able to consider the self-certification option.
However, the manufacturer must be able to guarantee that the device complies with the essential requirements established by the applicable directive/s (either through their own means or via test laboratories and/or research centres which offer the necessary facilities and specialised personnel), as well as ensuring sustained quality compliance with regard to products placed on the market.
One of the essential elements of the documentation which must be provided to demonstrate conformity assessment for a product, especially when a Notified Body is not involved, is the report showing conformity through testing based on harmonised standards, as well as information about the quality system in place.
8.- What is the difference between standardisation and certification?
Although there are similarities between these terms, they are used in different fields.
When we talk of the New Approach Directives, we always need to use the term certification (including self-certification and that by a Notified Body).
However, when we speak of national laws, we use the term standardisation. This is the case, for example, with slot machines which must be certified while also meeting gaming standards set by the Government.
9.- Is the CE Marking required to sell a product?
Yes. The manufacturer uses the CE Marking to indicate that the device complies with the essential requirements established in the applicable Community Directive/s.
The symbol is affixed by the manufacturer or their authorised EU representative. In exceptional cases, when permitted by the directive, it can be affixed by the party responsible for putting the product on the market in the EU. It must be affixed at the end of the production phase and be of an appropriate size (no smaller than 5 mm) and, where possible, must be placed on the product or the data plate.
It must be visible, legible and indelible. No other symbols that could be confused with the CE Marking can be featured.
In addition, as well as affixing the CE Marking, the manufacturer must have the following documents available for ten years from the date of commercialisation of the latest device:
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Declaration of Conformity
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Technical File
In exceptional cases, the DC relating to In Vitro Devices only requires the listed documentation to be held for five years following commercialisation of the latest device.
10.- If the components are CE certifiied, does the overall device also need certification?
The combination of two or more CE marked sub-systems does not always automatically produce a compliant system.
Let’s look at an example showing how the Electromagnetic Compatibility and Low Voltage Directives may be applied:
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Within the framework of the Electromagnetic Compatibility (EMC) Directive, the EMC environment in which a "system" is used must be taken into account as, if it differs from that for which it has been designed by the manufacturer of the devices inherent within it, the "system" may be subject to non-foreseen EMC difficulties. In addition, assembled "systems" may include both CE marked and non-CE marked sub-systems.
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In terms of the Low Voltage Directive, problems can be encountered with the sizing of devices, safety distances in the assembly that can affect the insulation, etc ...
