The presence of the logo on commercial products indicates that the manufacturer or importer affirms the goods' conformity with European health, safety, and environmental protection standards. It is not a quality indicator or a certification mark. The CE marking is required for goods sold in the European Economic Area (EEA); goods sold elsewhere may also carry the mark.
The Pressure Equipment Directive (PED) 2014/68/EU of the EU sets out the standards for the design and fabrication of pressure equipment generally over one liter in volume and having a maximum pressure more than 0.5 bar gauge. It also sets the administrative procedures requirements for the "conformity assessment" of pressure equipment, for the free placing on the European market without local legislative barriers. It has been mandatory throughout the EU since 30 May 2002, with 2014 revision fully effective as of 19 July 2016. The standards and regulations regarding pressure vessels and boiler safety are also very close to the US standards defined by the American Society of Mechanical Engineers (ASME). This enables most international inspection agencies to provide both verification and certification services to assess compliance to the different pressure equipment directives. From the pressure vessel manufactures PED does not generally require a prior manufacturing permit/certificate/stamp as ASME does.
Type approval or certificate of conformity is granted to a product that meets a minimum set of regulatory, technical and safety requirements. Generally, type approval is required before a product is allowed to be sold in a particular country, so the requirements for a given product will vary around the world. Processes and certifications known as type approval in English are often called homologation, or some cognate expression, in other European languages.
Product certification or product qualification is the process of certifying that a certain product has passed performance tests and quality assurance tests, and meets qualification criteria stipulated in contracts, regulations, or specifications.
ISO 13485Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices. The latest version of this standard supersedes earlier documents such as EN 46001 and EN 46002 (1996), the previously published ISO 13485, and ISO 13488.
Toy safety is the practice of ensuring that toys, especially those made for children, are safe, usually through the application of set safety standards. In many countries, commercial toys must be able to pass safety tests in order to be sold. In the U.S., some toys must meet national standards, while other toys may not have to meet a defined safety standard. In countries where standards exist, they exist in order to prevent accidents, but there have still been some high-profile product recalls after such problems have occurred. The danger is often not due to faulty design; usage and chance both play a role in injury and death incidents as well.
European Organisation for Technical Assessment (EOTA) is a European non-profit association. Its primary purpose is to draft the European Technical Assessment (ETA) documents. Once ratified, these become EU standards. Manufacturers and vendors of products that display the CE mark warrant that their products meet these standards.
The Medical Device Directive — Council Directive 93/42/EEC of 14 June 1993 concerning medical devices — is intended to harmonise the laws relating to medical devices within the European Union. The MD Directive is a 'New Approach' Directive and consequently in order for a manufacturer to legally place a medical device on the European market the requirements of the MD Directive have to be met. Manufacturers' products meeting 'harmonised standards' have a presumption of conformity to the Directive. Products conforming with the MD Directive must have a CE mark applied. The Directive was most recently reviewed and amended by the 2007/47/EC and a number of changes were made. Compliance with the revised directive became mandatory on 21 March 2010.
Deutsches Institut für Bautechnik (DIBt) is a technical authority in the construction sector. The Institute carries out its activities on the basis of an agreement concluded between the Federation and the German federal states (Länder). Its most important task is the approval of non-regulated construction products and construction techniques. The Institute is based in Berlin.
The End of Life Vehicles Directive is a Directive of the European Union addressing the end of life for automotive products. Every year, motor vehicles which have reached the end of their useful lives create between 8 and 9 million tonnes of waste in the European Union. In 1997, the European Commission adopted a Proposal for a Directive to tackle this problem.
A European Authorised Representative (E.A.R.) serves as a legal entity designated by non European Union (EU) manufacturers, to represent them in the EU and ensure their compliance with the European Directives. The CE certificate and declaration of conformity can only be issued by a company located in the European Union.
A notified body, in the European Union, is an organisation that has been designated by a member state to assess the conformity of certain products, before being placed on the EU market, with the applicable essential technical requirements. These essential requirements are publicised in European directives or regulations.
British Approvals Service for Cables is an independent accredited certification body headquartered in Milton Keynes, United Kingdom. Here, the organization's dedicated testing laboratory also operates which is believed to be the largest of its type in Europe. BASEC was established in 1971 and principally provides product certification services for all types of cable and wire, ancillary products and management systems within the cable industry. The organization maintains operations throughout the world including Africa, Middle East, America, Asia and Europe.
Construction Products Directive (Council Directive 89/106/EEC)(CPD) is a now repealed European Union Directive which aimed to remove technical barriers to trade in construction products between Member States in the European Union.
Market surveillance for products ensures that products on the market conform to applicable laws and regulations. This helps to foster trust among consumers buying products or financial services and protects consumers and professionals from harm from non-compliant products. It also helps companies that comply to stay in business and avoid losing market share to rogue traders.
The Recreational Craft Directive, Directive 2013/53/EU, originally Directive 94/25/EC on recreational craft amended by Directive 2003/44/EC, is a European Union directive which sets out minimum technical, safety and environmental standards for boats, personal watercraft, marine engines and components in Europe. It covers boats between 2.5 and 24m, personal watercraft, engines and a number of components built since 1998. It ensures their suitability for sale and use in Europe.
The Machinery Directive, Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 is a European Union directive concerning machinery and certain parts of machinery. Its main intent is to ensure a common safety level in machinery placed on the market or put in service in all member states and to ensure freedom of movement within the European Union by stating that "member states shall not prohibit, restrict or impede the placing on the market and/or putting into service in their territory of machinery which complies with [the] Directive".
The Eurasian Conformity mark is a certification mark to indicate products that conform to all technical regulations of the Eurasian Customs Union. It means that the EAC-marked products meet all requirements of the corresponding technical regulations and have passed all conformity assessment procedures.
EN 16034 refers to a set of European standards which specify the technical performance characteristics for fire resisting and/or smoke control products, or better known in common language as fire/smoke doors or fire/smoke proof doors. Compliance with this standard requires to fulfill the requirements of the Construction Product Regulation for construction products, which are placed on the EU market with the intention to become permanent parts of a construction.
Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. It repeals Directive 93/42/EEC (MDD), which concerns medical devices, and Directive 90/385/EEC, which concerns active implantable medical devices, on 26 May 2021.
