Europe is a competitive but prize market, easier to access than ever before. Too many Indian exporters, especially small and medium sized enterprises, avoid it because the technical requirements for entry seem too complicated, too difficult, or too expensive. Indian manufacturers who have successfully accessed the European market know that the time to understand the European system is well worth the effort. The European Union alone is filled with affluent consumers, approximately 450 million of them. The European market is a large area that comprises more than 25 countries.
For the exporter, therefore, Europe as a whole has become a market whose technical requirements have been greatly simplified. Before the creation of the European Union, each country imposed its own technical requirements. Different standards and conformity assessment procedures forced exporters to target one or two countries only, or to forego exporting to Europe altogether. The unification of these European countries into a European Union, and the consequent harmonization of laws, standards, and conformity assessment procedures, changed all that.
Perhaps more importantly, ISO 9001 Certification is used extensively in Europe as a condition of acceptance of a manufacturer’s product or as a means of recognition of the manufacturer’s credibility. It is important to note that a manufacturer with a quality system in place (such as ISO 9001 QMS) should not automatically assume that his or her products are CE compliant because of the quality system alone. The appropriate New Approach Directive(s) will prescribe the correct and full route to conformity assessment.
The CE Mark, which is affixed to a product or its packaging, is considered proof that a product has met the requirements of the harmonized European standard, or directive; refers to Communauté Européen. Translated from the French, this literally means European Community. The European Commission, which administers the program, describes the CE Mark as a passport for goods to be sold freely within the internal European market. It is required by law if the product falls under one of the New Approach Directives. It is not a quality mark, nor is it a mark for consumers. Intended for Member State authorities, it is the visible sign to those authorities that your product is in compliance with the New Approach Directives. All manufacturers are required to affix the CE mark to products that are governed by New Approach Directives. CE marking on a product indicates to all authorities that the product is in compliance with the essential health and safety requirements of all directives that apply to the product.
The first step to compliance is determining which directives apply to the product. A product may be regulated by more than one directive. The CE mark does not disclose which directive(s) or standards apply to the product, nor will it indicate the method of conformity assessment used to bring the product into compliance. This information is provided by other accompanying documents, such as the Declaration of Conformity. The Manufacturer or the Authorized Representative affixes the CE marking to the product. It is not affixed by a Notified Body.
List of New Approach directives for CE Marking :-
2006/95/EEC Low Voltage Equipment (LVD)
87/404/EEC Simple Pressure Vessels
88/378/EEC Toys Safety
89/106/EEC Construction Products
89/336/EEC Electromagnetic Compatibility (EMC)
89/686/EEC Personal Protective Equipment (PPE)
90/384/EEC Non-Automatic Weighing Instruments
90/385/EEC Medical Devices – Active Implantable
90/396/EEC Appliances Burning Gaseous Fuels
92/42/EEC New Hot-Water Boilers fired with Liquid or Gaseous Fuels (Efficiency Requirements)
93/15/EEC Explosives for Civil Uses
93/42/EEC Medical Devices – General (MDD)
94/9/EC Equipment and Protective Systems in Potentially Explosive Atmospheres (ATEX)
94/25/EC Recreational Craft
94/62/EC Packaging and Packaging Waste
95/16/EC Lifts
2014/68/EU Pressure Equipment (PED)
98/37/EC Machinery Safety
98/79/EC Medical Devices – In Vitro Diagnostic (IVD)
99/5/EC Radio Equipment and Telecommunications Terminal Equipment
00/9/EC Cableway Installations designed to Carry Persons
04/22/EC Measuring Instruments
GMP / GLP / GPP
W.H.O. defines Good Manufacturing Practices (GMP) as “that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization”. GMP covers all aspects of the manufacturing process: defined manufacturing process; validated critical manufacturing steps; suitable premises, storage, transport; qualified and trained production and quality control personnel; adequate laboratory facilities; approved written procedures and instructions; records to show all steps of defined procedures taken; full traceability of a product through batch processing records and distribution records; and systems for recall and investigation of complaints.
The guiding principle of GMP is that quality is built into a product, and not just tested into a finished product. Therefore, the assurance is that the product not only meets the final specifications, but that it has been made by the same procedures under the same conditions each and every time it is made. There are many ways this is controlled – controlling the quality of the facility and its systems, controlling the quality of the starting materials, controlling the quality of production at all stages, controlling the quality of the testing of the product, controlling the identity of materials by adequate labeling and segregation, controlling the quality of materials and product by adequate storage, etc. All of these controls must follow prescribed, formal, approved procedures, written as protocols, SOPs, or Master Formulae, describing all the tasks carried out in an entire manufacturing and control process.
