Category Archives: CE marking

FDA Enforcement Flags Data Integrity Risks at Overseas Labs

Posted on June 6, 2025 by Keith Cooper

The U.S. Food and Drug Administration (FDA) has issued formal warning letters to two overseas third-party labs for serious violations involving data falsification, poor quality controls, and noncompliance with regulatory standards—raising red flags for medical device manufacturers that outsource premarket … Continue reading →

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Cybersecurity and the new Radio Equipment Directive

Posted on May 28, 2025 by Keith Cooper

So, manufacturers, get your cybersecurity capes on. The EU is coming for your gadgets—and it means business. Brace Yourselves: The EU Is Mandating Cyber Hygiene for Wireless Devices Starting August 1, 2025, the EU is tightening the screws on anything … Continue reading →

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Hexavalent Chromium Faces EU Ban Under New Regulatory Shift

Posted on May 21, 2025 by Clare Wolffe

ECHA has proposed a new EU-wide restriction to protect the public from the effects of hexavalent chromium, Cr(Vi). ECHA assessed the risks and found that Cr(Vi) is the most potent workplace carcinogen. People living near industrial sites are also at … Continue reading →

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Unregulated Certificates Warning and The Implications Under EU Law

Posted on April 23, 2025 by Clare Wolffe

Recently, the European Commission updated some of the guidance regarding the EMC, ATEX, and Low Voltage Directives (and others) to include a warning about unregulated certificates. The warning explains that voluntary certificates issued by certification bodies not designated as notified … Continue reading →

Posted in ATEX Directive 2014/34/EU, CE marking, EMC Directive 2014/30/EU, Low Voltage Directive 2014/35/EU | Tagged , , , , , , | Comments Off on Unregulated Certificates Warning and The Implications Under EU Law

Is Machinery in Scope of the RoHS Directive?

Posted on April 13, 2025 by Peter Jolles

“My machine is industrial machinery, do I have to comply with RoHS for CE marking?” We are frequently asked this question. The answer is – yes, unless you fall into one of the exclusions available from the RoHS Directive 2011/65/EU. … Continue reading →

Posted in ATEX Directive 2014/34/EU, CE marking, Consulting, EMC Directive 2014/30/EU, International Testing, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Machinery Regulation (EU)2023/1230, Medical Devices Regulation (EU)2017/745, Pressure Equipment Directive 2014/68/EU, Product Testing, Prop 65, Radio Equipment Directive 2014/53/EU, REACH, RoHS Directive 2011/65/EU | Comments Off on Is Machinery in Scope of the RoHS Directive?

Taming the EMC Beast: A Guide to Pre-Compliance Testing

Posted on April 7, 2025 by Keith Cooper

Ah, the thrilling world of electromagnetic compatibility (EMC) testing! If you’ve ever dreamed of spending quality time with spectrum analyzers and line impedance stabilization networks (LISNs), you’re in for a treat. Let’s embark on a whimsical journey through the essentials … Continue reading →

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Prop 65 Alert: New Chemical Found in Plastics, Packaging and Paints

Posted on April 2, 2025 by Clare Wolffe

In January, a new chemical was added to the California Proposition 65 list. Vinyl Acetate was found to cause cancer and has been detected in food packaging, building materials, and contaminated air or soil. Let’s break this down: The list … Continue reading →

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So You Need a Field Evaluation?

Posted on March 26, 2025 by Keith Cooper

So, you’ve just had the pleasure of hearing from an Authority Having Jurisdiction (AHJ) or an electrical inspector, and their message was something along the lines of: “You’ve failed your inspection!” or “Your equipment needs a ‘UL or CSA Certification!’” … Continue reading →

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How to Navigate California Proposition 65

Posted on March 21, 2025 by Clare Wolffe

Almost anything being sold in California may require a Proposition 65 warning. Proposition 65 is a California law titled the Safe Drinking Water and Toxic Enforcement Act. The law was put in place to protect consumers and notify them if … Continue reading →

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Breaking Down California’s New Proposition 65 Labeling Guidelines

Posted on March 18, 2025 by Clare Wolffe

The Office of Environmental Health Hazard Assessment published regulatory changes to the short-form warning label requirements in 2025. The changes will affect the short-form label requirements, including limitations on when they can be used, updates to the required language, and … Continue reading →

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