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There are mechanisms in place to ensure that the CE marking is put on products correctly. Controlling products bearing CE marking is the responsibility of public authorities in member states, in cooperation with the European Commission. Citizens may contact national market surveillance authorities if the misuse of the CE marking is suspected or ...
As clarified in the Medical Devices Directive — Directive 93/42/EEC [4] — it is required that alongside the CE mark all products must also have an Authorised Representative. As stated in this amendment, an Authorised Representative should serve as a contact point with the EU member states competent authorities.
The CE mark found on the back of many electronic devices does not mean that the product has obtained type approval in the European Union. The CE mark is the manufacturer's declaration that the system/assembly meets the minimum safety requirements of all the directives (laws) applicable to it, and of itself, does not signify any third party ...
The article GE Healthcare Announces CE Marking for Its Breast Tomosynthesis Solution, SenoClaire originally appeared on Fool.com. Try any of our Foolish newsletter services free for 30 days .
CE Mark. 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.
product certifications (many nations) 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 (sometimes called "certification schemes" in the product certification industry).
ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] 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.
Canadian certification label on a bag of rockwool Counterfeit electrical cords with false UL certification marks. A certification mark on a commercial product or service is a registered mark that enables its owner ("certification body") to certify that the goods or services of a particular provider (who is not the owner of the certification mark) have particular properties, e.g., regional or ...