LEGALIZATION OF THE PRODUCT ON THE EU MARKET

Possible training topics:

• General introduction to the European Economic Area, European Community directives and the CE mark;
• Electromagnetic Compatibility Directive (EMC 2014/30/EU);
• Low Voltage Directive (LVD 2014/35/EU);
• Radio Equipment Directive (RED 2014/53 / EU);
• Machinery Directive (MD 2006/42/EC);
• Medical Devices Regulation and its requirements (745/2017/EU) (MDR).

Questions analyzed during directive training:

• the product is subject to EU safety legal requirements;
• product legalization procedure;
• requirements for the technical file of the product;
• selection of suitable test methods for the product;
• identification of defects for product validation.

During the training you will learn how to:

• identify applicable laws and requirements;
• choose the right compliance path;
• assess compliance;
• compile and prepare a technical file;
• declare conformity and CE mark.