Category Archives: CE marking

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 | Comments Off on CE Marking: Your Electronic Product’s Passport to Europe

ECHA Adds Five New Substances to SVHC List

The European Chemical Agency, ECHA, added five new substances to the list of Substances of Very High Concern (SVHC) overnight. The EU’s SVHC list expanded from 242 to 247 today. These are potentially dangerous substances that carry EU reporting responsibilities … Continue reading

Posted in CE marking, Consulting, REACH, RoHS Directive 2011/65/EU | Comments Off on ECHA Adds Five New Substances to SVHC List

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 | Comments Off on Does Customs Really Check For RoHS in The EU?

Embracing AI in Healthcare: The FDA’s Guidance on Good Machine Learning Practice

Embracing the Future: The FDA’s Guidance on AI in Medical Devices As we enter an exciting era of technological advancement, the role of artificial intelligence (AI) in medical devices stands out as particularly transformative. The FDA’s recent guidance on “Good … Continue reading

Posted in EN 60601-1, FDA, Medical Devices Regulation (EU)2017/745 | Comments Off on Embracing AI in Healthcare: The FDA’s Guidance on Good Machine Learning Practice

IEC 60601-1-9 Environmentally Conscious Design – What is it?

What exactly is the environmentally conscious design file?  You need documentation/policies that show how you are addressing the requirements of that standard.  You really should use the standard as guidance (IEC 60601-1-9).  Here is some good information on what this … Continue reading

Posted in CE marking, EN 60601-1, IEC 60601-1-9, Medical Devices Regulation (EU)2017/745 | Comments Off on IEC 60601-1-9 Environmentally Conscious Design – What is it?

Navigating CE Certification for Entry Into the European Market

As both established and startup consumer electronics manufacturers look to expand their market reach, the European Union presents an enticing, lucrative growth opportunity. Entry into this market comes with its prerequisites, however, one of which is CE certification testing. This … 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, Medical Devices Regulation (EU)2017/745, Pressure Equipment Directive 2014/68/EU, Radio Equipment Directive 2014/53/EU, RoHS Directive 2011/65/EU | Comments Off on Navigating CE Certification for Entry Into the European Market

The Machinery Regulation(EU)2023/1230 vs. Machinery Directive 2006/42/EC – What Is New?

The Machinery Regulation (EU)2023/1230 was published in 2023 but does not formally replace the Machinery Directive 2006/42/EC until 2027. F2 Labs performed a deep dive into the two EU regulations to figure out what is new, what is staying, and … Continue reading

Posted in CE marking, Consulting, Machinery Directive 2006/42/EC, UKCA | Comments Off on The Machinery Regulation(EU)2023/1230 vs. Machinery Directive 2006/42/EC – What Is New?

Hazardous Location Evaluations – ‘Behind the Scenes’ Details about Intrinsic Safety

Today, I read an email from our HazLoc engineering department that I think is extremely useful not only for F2 Labs personnel, but also for our clients who are working on what is required and how to comply. Your first … Continue reading

Posted in ATEX Directive 2014/34/EU, CE marking, Consulting, Machinery Directive 2006/42/EC | Comments Off on Hazardous Location Evaluations – ‘Behind the Scenes’ Details about Intrinsic Safety

I Want to Send a Flatscreen Monitor to the EU, What Now?

Navigating CE Compliance for entry into the EU can be daunting at times, because of the sheer number of regulations and Directives that may apply to your given product.  Without the help of a trusted testing partner (seriously, contact us … Continue reading

Posted in CE marking, Consulting, EMC Directive 2014/30/EU, General Product Safety Regulation (EU) 2023/988, GPSR, GPSR (EU)2023/988, Low Voltage Directive 2014/35/EU, Prop 65, Radio Equipment Directive 2014/53/EU, REACH, UL 62368-1 | Comments Off on I Want to Send a Flatscreen Monitor to the EU, What Now?

Pacemakers and Electric Cars

Over the past decade, we have seen an explosion of popularity with various green technologies, and at the forefront of that are electric vehicles and the charging stations that keep them going.  A new study questioned whether individuals who wear … Continue reading

Posted in CE marking, Consulting, EMC Directive 2014/30/EU, EMC Testing, FCC, FDA, Radio Equipment Directive 2014/53/EU | Comments Off on Pacemakers and Electric Cars