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The European Conformity Mark – CE
Free trade is one of European Union's cornerstones. But being able to put it into practice in a unique global market has been a complex step, taking in consideration that most countries protected their own interests through internal technical standards. Adequate legislation was required in order to surpass all these problems, which were eventually solved by harmonizing all standards inside the European Union. The result was the following: every company desiring to export its products into the EU would need the mandatory CE mark.
The CE Mark will only be granted if the manufacturer can prove that his product meets the technical requirements established in the corresponding standard, but also that the former is able to constantly manufacture that product at the same standard. Consequently, all products must be manufactured according to the specific internal procedures in such a way that the levels of the final quality are guaranteed. In most cases, this involves the manufacturer implementing a quality management system, EN ISO 9000 currently being the most adequate.
When a product is designed and manufactured in conformity with the requirements of a CE Directive it has to bear the CE Mark, in order to prove and assure all users in the European countries of this and also be legally marketed. The name of the mark comes from French, meaning “conform to the essential”.
The CE Mark is not a certification of quality, but a preliminary mandatory condition of product free trade, confirming with the essential health and safety requirements set out in European Directives. The CE Mark proves that a product (no matter its manufacturing place) is conform with the CE requirements.
The CE Mark certificates the fact that the product is a medical device. The MMD (Medical Device Directive (93/42/EEC + revised 2007/47/EC) defines a medical device as “any instrument, material or other article to be used for human beings for the purpose of diagnosis, prevention, monitoring or treatment of disease”.
The CE Mark is composed out of the initials “CE” in a specific format. In the case in which the mark needs to be reduced or enlarged, it is necessary to respect the proportions from the below picture:
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- Image dimensions: 41 x 24 squares;
- Internal diameter = 7 squares;
- External diameter = 10 squares;
- Center point coordinates : x 14, y 13; x 29, y 13 squares
The Medical Device Directive imposes that the product's label should contain the following elements:
- The CE Mark (according to the above specifications)
- The Notified Body Number (granted from Brussels) for the body bearing responsibility for applying all MDD procedures – this allows the user to verify whether that manufacturer and product have been granted the CE Mark. The Notified Body Number is not mandatory for non-sterile products.
- The name and address of the manufacturer (paragraph 13.3 (a) – to allow users to get in direct contact with the manufacturer in case of any questions and/or complaints.
- The single-use indication (paragraph 13.3 (f) – to avoid unnecessary risks of contamination in the OR and to minimize patient safety.
- The Sterile/Non-Sterile indication – even though this indication is not mandatory, it is important to make clear which products are sterile and which are non-sterile.
• The CE Mark is a European mandatory conformity mark
• The CE Mark is a symbol applied by the producer or its authorized representative on a product, its sterile wrapping (where possible), its commercial package and the user's instructions
• The CE Mark symbolizes the product conformity with all Union requirements set out in the European Directives
• Applied on a product before it is being marketed or used, the CE Mark indicates that the product is supposed to be conform with all requirements
• A product may not carry the CE Mark in the case in which a Directive clearly specifies it
• The CE Mark should be applied visibly, readable and in such a manner that it can't be erased
• When a notified body is involved in controlling the production, its identification number must be applied after the CE Mark
• The C and E components of the CE Mark should have the same vertical dimension, but this shouldn't be smaller than 5 mm (in order to ensure that it can be read)
• The CE Mark replaces all mandatory marks bearing the same signification
• The CE Mark consists from the CE letters, followed by the identification number of the notified body/bodies involved in the production (not in the evaluation of conformity). Some directives impose the indication of the last two digits of the year when the CE Mark has been applied. The pictographs or other markings (for example a registered mark or its use category) are according to the NA Directives complementary to the CE Mark, but do not constitute part of it. These supplementary markings must not be confounded with the CE Mark, nor should they reduce its visibility or legibility
• The Directives may exclude the application of the CE Mark on certain products, even if some aspects refer to that product. These specific products must be accompanied by a Conformity Declaration or another conformity document or certificate required by the directive.
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