CE Marking Evaluation Details & Options
During the development of the European Union, EU authorities developed an approach to facilitate the import of goods into the member states from other members states and the rest of the world. The EU authoritie developed directives issued under Article 100b of the EEC treaty. The purpose of the directives is to set binding requirements for trade goods throughout the EU focusing on product safety. These requirements are deemed "essential requirements" for all goods bought & sold in the EU. The manufacturer shows that the product conforms to the requirements of the Community directive by placing a CE mark on the product. The CE mark shows that the manufacturer declares his product to comply with all relevant directives (sometime referred to as "self-declaration").
ESTEC Solutions' evaluators are able to offer a variety of options to a manufacturer for CE Marking of their products. Two of the more common Safety Directives and ESTEC's Approaches to conformance are outlined below.
Low Voltage Directive CE Marking evaluation to include the following:
- A comprehensive evaluation of the equipment to the Low Voltage Directive utilizing harmonized standard EN 60204-1 or EN 61010, as appropriate.
- An informal Mechanical evaluation utilizing Annex I of the Machinery Directive.
- Internal Technical Peer Review.
- Closing meeting to verbally review list of discrepancy issues at the end of the on-site evaluation.
- An electronic copy of Bullet List Discrepancy Report issued within 3 working days following the On-site evaluation.
- An electronic copy of Final Evaluation Report issued within 14 working days following receipt of satisfactory responses to the Bullet List Discrepancy Report.
Machinery Directive CE Marking evaluation to include the following:
- A comprehensive evaluation of the equipment to the Machinery Directive utilizing appropriate harmonized standards (e.g., ISO 12100-1, ISO 12100-2, EN292-1, EN292-2, EN1050, EN982, EN983, and EN60204-1 or EN61010).
- Internal Technical Peer Review.
- Closing meeting to verbally review list of discrepancy isues at the end of the on-site evaluation.
- An electronic copy of Bullet List Discrepancy Report issued within 3 working days following the On-site evaluation.
- An electronic copy of Final Evaluation Report issued within 14 working days following receipt of satisfactory responses to the Bullet List Discrepancy Report.