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Category Archives: RoHS Directive 2011/65/EU
The Exemption for Medical Devices Under the RoHS Directive Has Expired
The RoHS Directive 2011/65/EU, Article 4 (3) exclusion for industrial monitoring and control instruments expired on Saturday, July 22, 2017. That exclusion was used by quite a few manufacturers to delay RoHS compliance, but Article 4 (3) is now gone. … Continue reading
Posted in CE marking, EMC Directive 2014/30/EU, Low Voltage Directive 2014/35/EU, RoHS Directive 2011/65/EU
Tagged CE, CE consulting, CE marking, RoHS, RoHS 2011/65/EU
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The EU declaration of conformity
A frequent source of confusion for exporters of products to the EU is the EU declaration of conformity. Many customers that we assist are vaguely familiar with the concept and the role of the “DoC”. The EU declaration of conformity … Continue reading
Posted in ATEX Directive 2014/34/EU, CE marking, EMC Directive 2014/30/EU, EN 60601-1, General Product Safety Directive 2001/95/EC, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Medical Devices Regulation (EU)2017/745, PPE Regulation (EU) 2016/425, Pressure Equipment Directive 2014/68/EU, Product Testing, R&TTE Directive 1999/5/EC, Radio Equipment Directive 2014/53/EU, RoHS Directive 2011/65/EU
Tagged ATEX 2014/34/EU, ATEX 94/9/EC, CE marking, Declaration of conformity, EC declaration of conformity, EMC 2004/108/EC, EMC 2014/30/EU, EU declaration of conformity, EU-type Examination Certificate, Low Voltage Directive 2006/95/EC, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, New Legislative Framework, New Legislative Framework 2008, NLF 2008, Technical File
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CE marking and the Technical File
Manufacturers who send equipment into the EU are required to send a CE compliant product in most cases. This means that if you are making an electromechanical device, chances are that you will need to comply with at least one, … Continue reading
Posted in ATEX Directive 2014/34/EU, CE marking, EMC Directive 2014/30/EU, General Product Safety Directive 2001/95/EC, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Medical Devices Regulation (EU)2017/745, PPE Regulation (EU) 2016/425, Pressure Equipment Directive 2014/68/EU, Product Testing, R&TTE Directive 1999/5/EC, Radio Equipment Directive 2014/53/EU, RoHS Directive 2011/65/EU
Tagged ATEX 2014/34/EU, CE, CE marking, EMC 2014/30/EU, EMC Directive 2014/30/EU, EN 61326-1, Low Voltage Directive 2014/35/EU, RED 2014/53/EU, RoHS, RoHS 2011/65/EU, RoHS compliance, RoHS Directive 2011/65/EU, Technical File
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New RoHS restrictions, substances added to Annex II
There is a change on the horizon for manufacturers used to complying with RoHS based on the restriction of the six substances indicated in RoHS 2011/65/EU (Annex II): Lead (0.1%) Mercury (0.1%) Cadmium (0.01%) Hexavalent chromium (0.1%) Polybrominated biphenyls (PBB) … Continue reading
Posted in CE marking, RoHS Directive 2011/65/EU
Tagged CE marking, Commission Delegated Directive (EU) 2015/863, REACH, REACH 1907/2006, Restriction of Hazardous Substances Directive 2011/65/EU, RoHS, RoHS 2011/65/EU, RoHS compliance, WEEE, WEEE 2012/19/EU, WEEE compliance
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Primer For CE and other European Compliance Markings
Manufacturers who build equipment for sale to customers in the European Union may spend a lot of time learning about and understanding the process that is required in order to sell their products with a CE marking on it. Placing … Continue reading
Posted in ATEX Directive 2014/34/EU, CE marking, EMC Directive 2014/30/EU, General Product Safety Directive 2001/95/EC, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Medical Devices Regulation (EU)2017/745, PPE Regulation (EU) 2016/425, Pressure Equipment Directive 2014/68/EU, Product Testing, R&TTE Directive 1999/5/EC, Radio Equipment Directive 2014/53/EU, RoHS Directive 2011/65/EU
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Harmonized EN standards, CE marking Directives and your European projects
Silently and slowly – but inexorably… the Directives and standards we use for CE marking are updated, revised, and replaced – and we must account for them. They must be correct when referenced on your declarations of conformity and that … Continue reading
Posted in ATEX Directive 2014/34/EU, CE marking, EMC Directive 2014/30/EU, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Medical Devices Regulation (EU)2017/745, PPE Regulation (EU) 2016/425, Product Testing, R&TTE Directive 1999/5/EC, Radio Equipment Directive 2014/53/EU, RoHS Directive 2011/65/EU
Tagged CE, CE consultation, CE marking, CE product testing, CEN, CENELEC, EN ISO 12100:2010, EN ISO 13849-1, EN ISO 13849-1:2008, EN ISO 13849-1:2015, EN standards, Harmonized EN standards, IEC, ISO, Machinery Directive, Machinery Directive 2006/42/EC, MD 2006/42/EC
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The Radio Equipment Directive and the Simplified EU Declaration of Conformity
I first read the new Radio Equipment Directive 2014/53/EU (aka the “RED”) in 2014 when it was published and noted its similarity to the other NLF Framework Directives as it pertains to the documentation compliance process and the conformity modules. … Continue reading
Posted in ATEX Directive 2014/34/EU, CE marking, EMC Directive 2014/30/EU, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Medical Devices Regulation (EU)2017/745, PPE Regulation (EU) 2016/425, Pressure Equipment Directive 2014/68/EU, Product Testing, R&TTE Directive 1999/5/EC, Radio Equipment Directive 2014/53/EU, RoHS Directive 2011/65/EU
Tagged CE, CE Certification, CE consulting, CE marking, CE marking certification, CE product testing, Declaration of conformity, EC declaration of conformity, EU certification, EU compliance, EU declaration of conformity, European compliance, Radio Equipment Directive 2014/3/EU, RED 2014/53/EU, RED CE marking
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RoHS Directive 2011/65/EU – Equipment for Research and Development
The understanding of many CE marking Directives is enhanced oftentimes by comparing a specific product to the recitals, articles, and annexes of the Directive and a detailed reading of the accompanying guidance document that is usually available to read alongside … Continue reading
Posted in CE marking, RoHS Directive 2011/65/EU
Tagged CE, CE Certification, CE consultation, CE marking, CE product testing, RoHS, RoHS 2, RoHS 2011/65/EU, RoHS Directive 2011/65/EU, Testing laboratory
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The RoHS Directive 2011/65/EU and Correct Markings to Indicate Compliance
The RoHS Directive 2011/65/EU, or ‘RoHS2’ as it is sometimes called, is a CE marking Directive and is a European law. The various RoHS markings seen on different pieces of equipment are illegal and have no legal meaning or standing. … Continue reading
Posted in CE marking, Product Testing, RoHS Directive 2011/65/EU
Tagged CE marking, Restriction of Hazardous Substances Directive 2011/65/EU, RoHS, RoHS 2011/65/EU, RoHS compliance, RoHS symbol, waste electrical and electronic equipment, WEEE, WEEE 2012/19/EU, WEEE compliance, WEEE symbol
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CE marking and the Requirement for Native Language Translations
Your compliance requirements for export to the EU do not stop with putting the CE marking on your equipment. Depending upon the applicable CE marking Directives that are relevant to your equipment, you may be required to prepare or be … Continue reading
Posted in ATEX Directive 2014/34/EU, CE marking, EMC Directive 2014/30/EU, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Pressure Equipment Directive 2014/68/EU, RoHS Directive 2011/65/EU
Tagged CE, CE marking, EMC 2004/108/EC, EMC 2014/30/EU, EMC Directive 2004/108/EC, EMC Directive 2014/30/EU, Low Voltage Directive 2006/95/EC, Low Voltage Directive 2014/35/EU, LVD 2006/95/EC, LVD 2014/35/EU, Machinery Directive, Machinery Directive 2006/42/EC, PED, PED 2014/68/EU, PED 97/23/EU, Pressure Equipment, Pressure Equipment Directive 2014/68/EU, Pressure Equipment Directive 97/23/EU
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