How ISO 13485 Differs From ISO 9001
The EU (European Union) is a huge marketplace where there is a seamless flow of goods and services. For enforcing greater integration of member states, the EU has adopted what it refers to as CE Marking directives. Such directives stipulate that products entering the EU must conform with certain standards.
The market power of the EU
The EU is one of the biggest economies in the world. It consists of 28 sovereign states and over 500 million people, thus having the 3rd largest population in the world. As per the World Bank, EU has a substantial presence in global trade and is poised to overtake the US as the premium business market in the world.
Agenda of business
The goal of the EU has always been to develop a market in which goods can be traded without any internal restrictions. For this, the EU has adopted the CE marking system. This implies that exporters must understand the procedure and implications of CE marking. This system harmonizes national systems of European standards.
What is CE?
The CE mark was conceived in 1985. It is an abbreviation of the French term- ConformitéEuropéenne, which means European Conformity. In 1995, the CE mark came into force for a wide variety of goods entering the EU. Though such directives avoided non-tariff barriers to trade in the EU, products being traded in the EU must comply with basic environmental and safety norms.
A CE marking certification implies that the product adheres to standards established by 28 nations European Union and makes the product tradeable in the EU. CE marking assumes compliance by importer or manufacturer with one or more directives regarding the product.
The CE mark is a specific form of certification or testing. It is not the same as a third-party certification. The CE mark simply permits the product to be placed in the EU market. It assures national officials that adherence to certain directives has been met.
The gist of this is that only products with CE mark can be sold in the EU. The mark is vital for manufacturers wishing to sell their products in the region. Exporters who wish to export to the EU will find that no matter how much EU importers wish to import products to the company, without CE marking, they run the risk of legal action against them.
Is it optional?
Products that do not comply with the essential needs of consumer protection, environment protection, health and safety stipulations will not only sell poorly, but manufacturers will be slapped with criminal prosecution.
When a product does not meet a CE mark, it is not legal to put for sale in the EU market. This provides the CE mark, the status of a passport to the EU. As such, some producers from outside EU might use the mark to mislead customs officials and gain entry into the EU market. Therefore, distributors of such products may be held responsible for making products comply with safety directives of the EU.
Member states of the EU are responsible for monitoring their domestic markets. In case products do not comply with CE mark regulations, they can be withdrawn from the market. In case of products entering the EU grey market, lacking CE marking, the manufacturer will be pressed with a legal action or required to modify the product such that it complies with all CE mark directives before being put for sale.