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Directives

Directives

EC Product Directives were created by the European Union (EU) to achieve the free movement of goods and services. The directives came about as a result of the Treaty of Rome, 1957. They are intended to remove any barriers to trade across Europe that could be caused by the multiple testing and certification of items and equipment to meet the regulations of individual EU member state markets.

Independent testing, inspection or certification of a product according to a directive must be done by a body that is approved by a government of the community and notified to the European Commission.

LRQA are an approved body and can provide independant certification to the relevant Directives that your business requires to deliver the products and services safely and of an expected standard to your customers.

Directives

  • In Vitro Diagnostic Medical Devices Directive

    The In Vitro Diagnostic (IVD) Medical Devices Directive is relevant to you if you design, manufacture or distribute IVD medical devices within the European Economic Area.

  • Medical Devices Directive

    The directive covers all products which claim to have a medical purpose and which are used in and on the human body, from heart valves to scalpels, excluding in vitro diagnostics, which are covered in a separate directive.