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Regulatory Requirements

Regulatory Requirements

Prevas has broad experience of regulatory work and certification activities from many different areas. We are updated and can give advice on how to meet the requirements. In some areas we have highly specialized competence e.g. in EMC and medical requirements.

The official regulations governing product requirements are often changed and updated. The new legislative framework (NLF) will affect many of the relevant directives. Keeping a close eye on future requirements, and prepare products to meet them, will reduce development and certification costs.

Selected relevant directives and regulations

  • EMC Directive 2004/108/EC. New revision 2014/30/EU, effective 2016-04-20. 
  • MDD Medical Devices Directive (93/42/EC). New revision proposed. 
  • Low Voltage Directive (73/23/EEC, 2006/95/EC). New revision 2014/35/EU, effective 2016-04-20. 
  • Machinery Directive (98/37/EC) rev. 2006/42/EC, effective 2009-12-29.

Environmental directives

  • RoHS: Restriction of Hazardous Substances Directive, regarding restricted use of certain hazardous substances in electrical and electronic equipment. RoHS 2: Revised 2011/65/EC, effective 2013-01-02 
  • WEEE: Waste Electrical and Electronic Equipment Directive, WEEE 2 revised 2012/19/EU, effective 2014-10-15 
  • ErP: Energy-related Products 2009/125/EC, directive for eco-design. 
  • REACH, regulation for registration, evaluation, authorization and restriction of chemicals, 1 June 2007.


Maria Månsson

Maria Månsson

Director, innovation and research


+46 8 644 36 07


With leading expertise in high-tech product development, embedded systems and industrial IT & Automation, Prevas contributes by providing innovative solutions and services that create growth.

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