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

Great Britain’s UKCA mark – September 2020 Update

Posted on September 5, 2020 by Peter Jolles

We published an article about Brexit and its implications for CE marking back in February of this year. A link to that article is here. The UK government posted new guidance about this on September 1, 2020. The link to … Continue reading →

Posted in ATEX Directive 2014/34/EU, CE marking, EMC Directive 2014/30/EU, EMC Testing, General Product Safety Regulation (EU) 2023/988, GPSR, 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, UKCA | Comments Off on Great Britain’s UKCA mark – September 2020 Update

Is the CE marking still valid now that Brexit has happened?

Posted on February 6, 2020 by Peter Jolles

Yes, for now. CE marking will be accepted until at least the end of 2020 and then the UKCA mark will be the replacement mark for products sent to the UK. The link to the official UK page regarding this … Continue reading →

Posted in ATEX Directive 2014/34/EU, CE marking, EMC Directive 2014/30/EU, EU Battery Regulation (EU)2023/152, General Product Safety Regulation (EU) 2023/988, GPSR, 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 | Comments Off on Is the CE marking still valid now that Brexit has happened?

Important CE Marking Questions and Answers

Posted on August 2, 2019 by Peter Jolles

Frequently at F2 Labs we get deep into various topics regarding CE marking and other compliance requirements. I can only imagine the sinking feeling that a manufacturer must feel when seeing this on a request for bid: CE marking required. … Continue reading →

Posted in ATEX Directive 2014/34/EU, CE marking, Consulting, EMC Directive 2014/30/EU, EMC Testing, General Product Safety Directive 2001/95/EC, GPSR, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Medical Devices Regulation (EU)2017/745, Pressure Equipment Directive 2014/68/EU, Radio Equipment Directive 2014/53/EU, REACH, RoHS Directive 2011/65/EU | Comments Off on Important CE Marking Questions and Answers

F2 sorts out Compliance Requirements for you

Posted on July 30, 2019 by Peter Jolles

Manufacturers contact F2 Labs from around the world for assistance with EU regulations. While F2 Labs primarily focuses on electro-mechanical devices, including medical devices, we have also assisted many people with an understanding of what is legally required. An example … Continue reading →

Posted in ATEX Directive 2014/34/EU, CE marking, Consulting, EMC Directive 2014/30/EU, EU Battery Regulation (EU)2023/152, General Product Safety Regulation (EU) 2023/988, GPSR, Lasers, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Medical Devices Regulation (EU)2017/745, Pressure Equipment Directive 2014/68/EU, Radio Equipment Directive 2014/53/EU, REACH | Tagged , , , | Comments Off on F2 sorts out Compliance Requirements for you

CE marking – Equipment is stopped in French customs, what now?

Posted on June 6, 2019 by Peter Jolles

The sales department at F2 Labs fields phone calls from primarily US manufacturers. We have heard every scenario imaginable as pertains CE marking, from, “What is CE marking? We are about to disassemble and crate our machine and noticed that CE … Continue reading →

Posted in ATEX Directive 2014/34/EU, CE marking, Consulting, EMC Directive 2014/30/EU, EU Battery Regulation (EU)2023/152, General Product Safety Regulation (EU) 2023/988, GPSR, 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 CE marking – Equipment is stopped in French customs, what now?

Guidance For Wire Colors in Machines in the EU

Posted on June 3, 2019 by Peter Jolles

We help manufacturers every day with the task of CE marking their equipment for shipment to the EU. Very often we are asked questions by our customer’s engineering staff and one of the most common questions pertains to wire colors. … Continue reading →

Posted in CE marking, Consulting, EMC Directive 2014/30/EU, General Product Safety Regulation (EU) 2023/988, GPSR, 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 Guidance For Wire Colors in Machines in the EU

What is the Critical Component List?

Posted on January 18, 2019 by Peter Jolles

F2 Labs performs safety evaluations & testing, EMC testing, and consulting for various compliance related issues faced by our customers. We open safety evaluations at F2 Labs by sending a list of information we need in order to review the … Continue reading →

Posted in CE marking, Consulting, EN 60601-1, General Product Safety Directive 2001/95/EC, Listing, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Medical Devices Regulation (EU)2017/745, Product Testing, Radio Equipment Directive 2014/53/EU, RoHS Directive 2011/65/EU, UL 60335-1, UL 61010-1, UL 62368-1 | Comments Off on What is the Critical Component List?

The Ambiguity of the CE Marking Process

Posted on June 1, 2018 by Peter Jolles

Yesterday I posted an article pertaining to last week’s RAPEX report and the scope of the Low Voltage Directive 2014/35/EU. Today I reviewed this week’s ‘catch’ of non-conforming products and it is a very illustrative of the opaqueness, sometimes, of … Continue reading →

Posted in ATEX Directive 2014/34/EU, CE marking, EMC Directive 2014/30/EU, General Product Safety Directive 2001/95/EC, 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 The Ambiguity of the CE Marking Process

CE marking Onsite Consulting and Training

Posted on March 6, 2018 by Peter Jolles

F2 Labs is able to send a CE marking expert to your facility to provide overview training to your business – sales and engineering. We can quickly dig into the Directives that apply to your specific products and show your … Continue reading →

Posted in ATEX Directive 2014/34/EU, CE marking, Consulting, EN 60601-1, General Product Safety Directive 2001/95/EC, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Medical Devices Regulation (EU)2017/745, PPE Regulation (EU) 2016/425, Pressure Equipment Directive 2014/68/EU, R&TTE Directive 1999/5/EC, Radio Equipment Directive 2014/53/EU, REACH, RoHS Directive 2011/65/EU | Tagged , , , , , | Comments Off on CE marking Onsite Consulting and Training

RoHS 2011/65/EU and Machinery

Posted on February 5, 2018 by Peter Jolles

F2 Labs assists many manufacturers, internationally, with CE marking requirements. Regarding CE marking, primarily we test and evaluate electro-mechanical equipment for compliance with electrical safety, machinery safety, EMC and radio, medical device, and hazardous location requirements. However, when a manufacturer … Continue reading →

Posted in ATEX Directive 2014/34/EU, CE marking, Consulting, EMC Directive 2014/30/EU, General Product Safety Directive 2001/95/EC, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Medical Devices Regulation (EU)2017/745, Product Testing, Radio Equipment Directive 2014/53/EU, RoHS Directive 2011/65/EU | Tagged , , , , , , , , , , | Comments Off on RoHS 2011/65/EU and Machinery