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Recent Posts
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Category Archives: PPE Regulation (EU) 2016/425
CE Marking: Your Electronic Product’s Passport to Europe
If electrical products had passports, the CE mark would be their golden ticket to travel freely across Europe. But unlike that dusty old passport you forgot to renew, CE marking isn’t just a stamp—it’s a declaration of compliance with essential … Continue reading
Posted in ATEX Directive 2014/34/EU, CE marking, EMC Directive 2014/30/EU, General Product Safety Regulation (EU) 2023/988, GPSR, GPSR (EU)2023/988, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Machinery Regulation (EU)2023/1230, Medical Devices Regulation (EU)2017/745, PPE Regulation (EU) 2016/425, Pressure Equipment Directive 2014/68/EU, Radio Equipment Directive 2014/53/EU, REACH, RoHS Directive 2011/65/EU
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Does Customs Really Check For RoHS in The EU?
Yes. I get an email every week from the European Commission’s Safety Gate that lists some of the most dangerous products that were recently pulled from the market. These alerts are for products stopped in customs before they enter the … Continue reading
Posted in ATEX Directive 2014/34/EU, CE marking, Consulting, EMC Directive 2014/30/EU, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Machinery Regulation (EU)2023/1230, PPE Regulation (EU) 2016/425, Pressure Equipment Directive 2014/68/EU, Product Testing, Radio Equipment Directive 2014/53/EU, REACH, RoHS Directive 2011/65/EU
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What Now?
A comprehensive guide into the listing standards that are required after testing to compliance marks. Continue reading
Posted in ATEX Directive 2014/34/EU, CE marking, EMC Directive 2014/30/EU, FCC, FDA, Field Label, GPSR, GPSR (EU)2023/988, International Testing, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Machinery Regulation (EU)2023/1230, Medical Devices Regulation (EU)2017/745, PPE Regulation (EU) 2016/425, Pressure Equipment Directive 2014/68/EU, Prop 65, Radio Equipment Directive 2014/53/EU, REACH, RoHS Directive 2011/65/EU, SPE-1000, UKCA, US Field Label
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The Ambiguity of the CE Marking Process
Yesterday I posted an article pertaining to last week’s RAPEX report and the scope of the Low Voltage Directive 2014/35/EU. Today I reviewed this week’s ‘catch’ of non-conforming products and it is a very illustrative of the opaqueness, sometimes, of … 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, Machinery Regulation (EU)2023/1230, Medical Devices Regulation (EU)2017/745, PPE Regulation (EU) 2016/425, Pressure Equipment Directive 2014/68/EU, Radio Equipment Directive 2014/53/EU, REACH, RoHS Directive 2011/65/EU
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CE marking Onsite Consulting and Training
F2 Labs is able to send a CE marking expert to your facility to provide overview training to your business – sales and engineering. We can quickly dig into the Directives that apply to your specific products and show your … Continue reading
Posted in ATEX Directive 2014/34/EU, CE marking, Consulting, 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, R&TTE Directive 1999/5/EC, Radio Equipment Directive 2014/53/EU, REACH, RoHS Directive 2011/65/EU
Tagged CE, CE mark, CE marking, EU, European Commission, European Union
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EU’s Rapid Alert System for dangerous non-food products
The EU has a direct conduit for market surveillance authorities to communicate information about non-compliant products directly between 31 EU member nations and the European Commission. This system is called the Rapid Alert System, or RAPEX. This is not where … Continue reading
Posted in ATEX Directive 2014/34/EU, CE marking, Consulting, EMC Directive 2014/30/EU, EN 60601-1, General Product Safety Directive 2001/95/EC, IP Testing, Lasers, 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, Radio Equipment Directive 2014/53/EU, RoHS Directive 2011/65/EU
Tagged CE, CE mark, CE marking, EU consumer protection, EU market surveillance, European Commission, European compliance, RAPEX, Rapid Alert System
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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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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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