- Authorised representative
A person or entity established within the EU who has a written mandate from a manufacturer to act on its behalf for specified compliance obligations.
- Blue Guide
European Commission Guidance document on the interpretation of many European product regulatory regimes. Learn more
- Business Gateway
European Commission online tool that can be used to report product safety issues to Member State authorities (formerly known as a business application). (See also “RAPEX” and “Safety Gate”) Learn more
- CE mark
Required by many European product regulations. Where applicable, it must be affixed to the product by the manufacturer, as part of the manufacturer’s declaration that the product complies with the applicable mandatory requirements. Learn more
- Conformity assessment
The process by which it is confirmed that a product complies with applicable technical regulations. Often carried out by a third party testing agency.
- Declaration of Conformity
Under certain European regulations, a mandatory declaration by a manufacturer that a product complies with the applicable requirements.
A form of EU legislation, that must be implemented into local law by EU Member States (see also “Regulation”). Learn more
Electromagnetic compatibility – usually used to refer to requirements that electrical and electronic equipment be designed so as to avoid cross-interference with other devices and systems under the Electromagnetic Compatibility Directive (2014/30/EU). Learn more
General Product Safety Directive (2001/95/EC) – European legislation dealing with safety requirements for consumer products marketed in the EU. In addition, sector-specific legislation may also apply depending on the product. Learn more
- Harmonised standard
A technical standard that has been formally accepted by the European Commission as giving rise to a presumption that a product complies with certain requirements.
Low Voltage Directive (2014/35/EU) – the European requirements for the safety of certain electrical equipment. Learn more
- Member State
One of the 27 countries that is currently a member of the European Union.
The New Legislative Framework – a package of legislation setting out a common legal framework for European product legislation (in effect a legislative template) and a framework for the market surveillance of harmonised products (i.e. applying to CE marked products). Learn more
- Notified body
A testing agency that has been officially designated by a Member State to carry out certain conformity assessment tasks, when use of a third party is required Certifications of a Notified Body are, in certain circumstances, strong and reliable evidence of compliance.
Risk Assessment Guidelines – the European Commission’s online tool to assist in producing Risk Assessments for unexpected risks identified in products that are already on the market. Learn more
The European Commission’s tool for the “Rapid Exchange” of information on product safety issues. Shares information between Member States and the European Commission. Some information is also made available to the public (see also “safety gate” and “business gateway”).
Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals – the European regime for regulating the safety of chemicals. Learn more
Radio Equipment Directive (2014/53/EU) – the European requirements for safety and compatibility of equipment emitting or utilising radio waves in various forms. Learn more
A form of EU legislation that is directly binding on Member States, and not necessarily requiring specific local legislation (see also “Directive”). Learn more
- Responsible person
A person or entity designated under certain European product regulations to take responsibility for specified compliance obligations.
- Risk assessment
An assessment of the safety risks potentially presented by a product, usually involving a consideration of both the potential severity of injury/damage, and the likelihood of the harm arising. Normally required before a product is placed on the market, as well as to consider what responses are appropriate if an unexpected risk is identified involving a marketed product. (See also “RAG”).
Restriction on Hazardous Substances Directive (2011/65/EU) – the European regime for regulating the use of potentially hazardous substances in electrical and electronic equipment. Learn more
- Safety Gate
The European Commission’s public-facing tool for sharing certain information about product safety issues (see also “RAPEX” and “Business Gateway”). Learn more
- Technical documentation/technical file
Specific documentation required to be kept by a manufacturer (or “Responsible Person”) in certain circumstances verifying the safety and conformance of a marketed product.
Waste Electrical and Electronic Equipment – usually used to refer to the European requirements for producers of such equipment to take responsibility for aspects of the end-of-life of such equipment under the Waste Electrical and Electronic Equipment Directive (2012/19/EU). Learn more