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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 Machinery Directive, 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 effective in 2021.
- 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, effective 2014-10-15.
- 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.
inspiration
Since the beginning in 1985, we’ve joined with our customers in solving tens of thousands of problems – and in most industries.
Explore possibilities we have discovered together with clients
example of competences
Want to know more? Contact us about what we can do for you.
References
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Biosensor Applications
Border control detection systems
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ILIAS Solutions
ILIAS Solutions take vehicle maintenance to the next level
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Emerson
Updated I/O box future-proofs Emerson's tank radar system
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Nipro Medical Europe
Prevas UX/UI-expertise helps Nipro choose the right solutions within new design concept
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