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A conformity mark on a product indicates that the product complies with the regulatory requirements concerning its design, construction and marketing in a given national or international market.

As far as the EU is concerned, the European Commission has issued a large number of Directives (EU Directives) outlining legislation and Community rules and requirements on a variety of issues. A special category of Directives, known as the "New Approach Directives", have as their object the simplification of the procedures of import and distribution of products to and within the Member States of the European Union.


The CE marking is an acronym for the French word "Communauté Europèenne" and means European Compliance.

The current list of New Approach Instructions and products that fall within their scope includes:

1. Directive 93/42/EC on Medical Devices


2. Directive 2014/34/EU (ATEX) on Devices for Use in Explosive Atmospheres.


3. Directive 94/25/EC for Pleasure Boats


4. Directive 95/16/EC on Lifts


5. Directive 2014/68/EU {rep. 97/23 / EC (PED)} for Pressure Equipment


6. Directive 98/79 / EC on Medical Devices for In Vitro Diagnosis


7. Directive 2006/95 / EC on Low Voltage Equipment


8. Directive 2009/105 / EC (SPVD) for Simple Pressure Vessels


9. Directive 2009/48 / EEC on Toy Safety


10. Regulation 305/20118 for Products of the Construction Sector


11. Directive 2004/108 / EEC on Electromagnetic Compatibility


12. Directive 2006/42 / EC on Machinery


13. Directive 89/686 / EEC on Personal Protective Equipment


14. Directive 2009/23 / EEC on Manual Weighing Instruments


15. Directive 90/385 / EEC on Active Implantable Medical Devices


16. Directive 2009/142 / EC on Gas Appliances


17. Directive 93/15 / EEC on Explosives for Commercial Use


18. Directive 1999/5 / EC on Radio Equipment and Telecommunication Terminal Equipment


19. Directive 2000/9 / EC on Cable Car Installations for the Transport of Persons


20. Directive 2004/22 / EC (MID) on Measuring Instruments


21. Directive 94/25 / EC for Pleasure Boats


22. Directive 2011/65 / EC on the restriction of the use of certain dangerous substances in electronic and electrical equipment.


23. Directive 2010/35 / EU on transportable pressure equipment (TPED)


Contact us if your products fall within the scope of the above Instructions to guide you in the development of the System



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