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Recent Posts
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Category Archives: Medical Devices Regulation (EU)2017/745
Is Machinery in Scope of the RoHS Directive?
“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
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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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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
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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
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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 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
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ESD and Electric Vehicles (EVs) – New Challenges
Electric vehicle (EV) technology continues to evolve, grow, and become more commonplace. Changes and an increase in popularity will continue, especially with the insertion of ethernet technology for data communication in those systems. ESD protection is extremely important; especially in … Continue reading
Posted in CE marking, EMC Directive 2014/30/EU, EMC Testing, EN 60601-1, FCC, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Machinery Regulation (EU)2023/1230, Medical Devices Regulation (EU)2017/745, Product Testing, Radio Equipment Directive 2014/53/EU
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Enforcement of the UKCA Mark is Postponed
On November 14, 2022 the UK announced that use of the UKCA Mark (for Great Britain) is to be postponed an additional two years until December 31, 2024. Previously, mandatory use of the mark and scheme was supposed to 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, Machinery Regulation (EU)2023/1230, Medical Devices Regulation (EU)2017/745, Pressure Equipment Directive 2014/68/EU, Radio Equipment Directive 2014/53/EU, REACH, RoHS Directive 2011/65/EU, UKCA
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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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What is a CE marking? Does My Product Need One?
The CE mark is a mandatory European marking for certain product groups to indicate conformity with the essential requirements set out in European Directives. To use the CE mark on a product, the manufacturer must draw up an EU Declaration of … Continue reading
Posted in ATEX Directive 2014/34/EU, CE marking, EMC Directive 2014/30/EU, EMC Testing, GPSR, GPSR (EU)2023/988, Lasers, 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, Radio Equipment Directive 2014/53/EU, RoHS Directive 2011/65/EU
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Great Britain Changed the UKCA Deadline for Implementation, Again
The COVID-19 pandemic has thrown us all for a loop. Effects of the pandemic have been seen across many industries, supply chains, and more, including the extension of deadlines for product compliance regulations. In a statement on August 24th, 2021, … Continue reading
Posted in ATEX Directive 2014/34/EU, CE marking, EMC Directive 2014/30/EU, EN 60601-1, 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, Pressure Equipment Directive 2014/68/EU, Product Testing, Radio Equipment Directive 2014/53/EU, REACH, RoHS Directive 2011/65/EU
Tagged UKCA
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