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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 technology 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

  • LVD, Low Voltage Directive. New revision 2014/35/EU, effective2016-04-20.
  • EMC Directive. New revision 2014/30/EU, effective 2016-04-20.
  • RED, Radio Equipment Directive(replaces R&TTE directive), 2014/53/EU effective since 2016-06-13, after transition in sharp mode from 2017-06-13.
  • MDD, Medical Devices Directive (93/42/EC). New revision 2017/745 will be effective from 2020-05-26. 
  • MD, Machinery Directive 2006/42/EG, 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, new revision 2011/65/EG, effective 2013-01-02. 
  • WEEE: Waste Electrical and Electronic Equipment Directive. WEEE 2 revised 2012/19/EU, effective2014-10-15.
  • ERP, Eco-design directive. Framework directive 2009/125/EG. Continuous updates.
  • REACH 1907/2006, regulation for registration, evaluation, authorization and restriction of chemicals, 1 June 2007. Continuous updates.

DO YOU HAVE A TECHNICAL CHALLENGE?

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Maria Månsson

Director, innovation and research & Site Manager Hammarby Sjöstad

Tel +46 70 864 43 99

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References

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  • Implantica 

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