Technical words and terms in Swedish and English with explanations in English 







Anmält Organ Notified bodies  Notified bodies have been notified with the European Commission as competent/accredited to test and certify products in cases in which the law requires verification by an independent third party.
Ackreditering av företag/organisationer som arbetar med att bedöma produkters överensstämmelse med lagens krav Accreditation of conformity assessment bodies  A third-party assurance that the companies/organisations have been designated to assess the CE label (among others) and perform tests. Has the specific skills necessary to perform the respective duties.
Cassis de Dijon principen (EG domstolen, rättsfall C-120/78) Cassis de Dijon principle (ECJ Case C-120/78)  Mutual recognition. This means a product that follows the national legislation and which is not subject to harmonised EU legislation is free to be sold in other countries.
CE-märkning CE-marking  The CE label on a product means that the product meets the requirements of the relevant directives and has undergone a prescribed procedure to verify that the product conforms to the requirements (e.g. tested by a notified body).
Bedömning av överensstämmelse ( kraven som anges i t ex ett direktiv). Conformity assessment  Manufacturers must ensure that their products truly meet the requirements specified in the directives i.e. a conformity assessment. The directives specify different procedures (ways) to show that the design and manufacture of the product complies with the requirements. The procedures are divided into "modules" that cover the design phase, the production phase, or both.
Försäkran om överensstämmelse Declaration of Conformity  A declaration of the manufacturer of the product or an authorised representative of the EU endorsing that a particular product meets the requirements of the specified directives. In the declaration, it should be possible to identify the manufacturer or representative, product, and current directives as well as possibly the standards referenced and/or controlling notified body.
Grundläggande hälso- & säkerhetskrav Essential health and safety requirements  The directives contain overall health and safety requirements for the design and use. The requirements are binding. It is the manufacturer's responsibility to choose a technical solution that meets these requirements.
Harmoniserade standarder Harmonised standards  When published with the title, the "Harmonisation of a standard" commission references to the current directive in the "Official Journal". Once the standard is adopted, it must be published by the national members of the Organisation for Standardisation (i.e. CEN, CENELEC, and ETSI). The old standards are simultaneously withdrawn.
Marknadsövervakning Market Surveillance  Market surveillance is an important tool for implementing directives designed according to the new method. Market surveillance needs to function effectively to achieve: a uniform application of EU legislation. Equal protection for all residents. To maintain a level playing field for businesses. To achieve this, national surveillance authorities must be able to certify that products placed on the market are in line with the current legislation. If necessary, the authorities must take action against the manufacturer/importer in order to achieve compliance.
Moduler Module The directives specify different procedures (ways) to show that the design and manufacture of the product complies with the requirements. The procedures are divided into "modules" from A to H that cover the design phase, the production phase, or both. Module A means that the manufacturer can certify their product. The other modules usually require some form of intervention by a notified body.
Avtal om ömsesidigt erkännande MRA- mutal recognition agreements  Mutual recognition agreements in force between the European Community and third countries that have achieved a comparable technological development. These agreements are based on the mutual acceptance of test reports and the certifications of the notified bodies of one party.
Direktiv enligt den nya metoden New Approach Directives  Directive designed according to a new method that contains only general but mandatory health and safety requirements (all CE label directives, among others). Technical details can be found in the harmonised standards, which are linked to the directives. Member states are obliged to implement the directive so that they will become part of national law.
Släppa ut på marknaden Placing on the market  To launch a product or make it available on the European market. The product can accessed either at a cost or no cost.
Överensstämmelse förutsätts Presumption of conformity  Products that correspond with the related harmonised standards automatically fulfil the corresponding requirements of the directives.
Produktansvar Product Liability  The manufacturer of a product is responsible if said product causes damage to persons or property even if the product meets the requirements of national and/or European legislation. The principle of product liability applies to both industrial and agricultural products.
Standarder Standards  Technical specifications are adopted by national, European, or international standards organisations for recurring or continuous use. The use of standards is voluntary and intended as an aid.
Teknisk dokumentation Technical file  The directives require the manufacturer to establish a technical documentation to demonstrate that the product meets the current requirements. Content governed by various directives; requirements vary depending on the products concerned.