Category Archives: Medical Devices Regulation (EU)2017/745

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?

CE Marking: Your Electronic Product’s Passport to Europe

Posted on February 5, 2025 by Keith Cooper

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

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

Posted on September 30, 2024 by Keith Cooper

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?

Posted on August 14, 2024 by Keith Cooper

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

Posted on July 19, 2024 by Intero Digital

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

ESD and Electric Vehicles (EVs) – New Challenges

Posted on January 5, 2023 by Keith Cooper

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 | Comments Off on ESD and Electric Vehicles (EVs) – New Challenges

Enforcement of the UKCA Mark is Postponed

Posted on November 21, 2022 by Keith Cooper

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 | Comments Off on Enforcement of the UKCA Mark is Postponed

What Now?

Posted on February 3, 2022 by Keith Cooper

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 | Comments Off on What Now?

What is a CE marking? Does My Product Need One?

Posted on December 2, 2021 by Keith Cooper

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 | Comments Off on What is a CE marking? Does My Product Need One?

Great Britain Changed the UKCA Deadline for Implementation, Again

Posted on September 15, 2021 by F2 IT

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 | Comments Off on Great Britain Changed the UKCA Deadline for Implementation, Again