Category Archives: CE marking

Cracking the Code: Surviving the FDA’s AI-Enabled Medical Device Guidance (With Sanity Intact)

Buckle up, folks—our favorite regulatory sheriffs at the FDA have dropped another massive rulebook, this time titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” If you’re still awake after reading that title, congratulations! This document is … Continue reading

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CE Marking: Your Electrical 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

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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

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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 | 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

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NRTL Field Evaluation and Labeling

If an Authority Having Jurisdiction (AHJ) or electrical inspector has ever informed you that you have failed your inspection or that you require a “UL or CSA Certification” or that your equipment must be “UL/CSA Certified” or “UL/CSA Labeled” we … Continue reading

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Common Electromagnetic (EM) Emitters

The FDA, per their Guidance Document published June 6, 2022, requires that medical device manufacturers be able to show that their product is immune to common Electromagnetic (EM) Emitters, such as RFID Readers, Near-field Communication (NFC) systems, metal detectors, Electronic … Continue reading

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Easy Approach to Essential Performance in Medical Devices for FDA

F2 Labs has many conversations every week with medical device manufacturers who are struggling to define Essential Performance for their device.  From our experience, the confusion around Essential Performance frequently stems from the fact that what a device manufacturer views … Continue reading

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Environmentally Conscious Design

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

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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. This certification … 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