Tag Archives: CE marking

Unregulated Certificates Warning and The Implications Under EU Law

Recently, the European Commission updated some of the guidance regarding the EMC, ATEX, and Low Voltage Directives (and others) to include a warning about unregulated certificates. The warning explains that voluntary certificates issued by certification bodies not designated as notified … Continue reading

Posted in ATEX Directive 2014/34/EU, CE marking, EMC Directive 2014/30/EU, Low Voltage Directive 2014/35/EU | Tagged , , , , , , | Comments Off on Unregulated Certificates Warning and The Implications Under EU Law

On The Need For Translations

This is an often-asked question, “Do I need to translate the manual for the EU and what do I need to translate?” The answer is everything that is needed top assemble, safely operate, maintain, and eventually dispose of the equipment … Continue reading

Posted in ATEX Directive 2014/34/EU, CE marking, Consulting, EMC Directive 2014/30/EU, Low Voltage Directive 2014/35/EU, Pressure Equipment Directive 2014/68/EU, Radio Equipment Directive 2014/53/EU | Tagged , | Comments Off on On The Need For Translations

F2 sorts out Compliance Requirements for you

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

EN 62368-1:2014 will replace EN 60950-1 and EN 60065

EN 62368-1:2014 will replace two main EN standards on December 20, 2020. A year or two years ago this seemed a long way off. Now it is right around the corner. To begin with, we want to take a look … Continue reading

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New RoHS standard – EN 63000:2018

CENELEC has published a new RoHS standard, announcing it, here. The new standard is EN ISO 63000:2018 Technical Documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances. The referenced CENELEC article indicates … Continue reading

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RoHS 2011/65/EU and a Tale of Three Guitars

The world has many good guitar manufacturers but it is commonly accepted that the very best guitars are made in the United States. Few guitar players will dispute that. In the world of acoustic guitars there are three ‘big’ manufacturers … Continue reading

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REACH Regulation (EC) No 1907/2006 – Article 7, Annex VII, and practical considerations for manufacturers – the CRASH COURSE

One possible cause for an audible “gulp” coming from the reader of a specifications sheet is coming across a requirement to comply, vaguely, with the REACH Regulation (EC) 1907/2006. Broadly, REACH is meant to ensure that products in Europe do … Continue reading

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Partly completed machinery and the requirement for Assembly Instructions

Manufacturers who build parts of machines or incomplete machinery (for example: no controls) must be aware that their equipment must not carry a CE marking if the equipment is not in scope of any other Directive(s) and must follow a … Continue reading

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CE marking Onsite Consulting and Training

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

Spare Parts and the RoHS Directive

The RoHS Directive 2011/65/EU was amended in November 2017 by Directive (EU) 2017/2102 with some administrative clarifications. I found one item particularly interesting: Recital (2): (2) Secondary market operations for EEE, which involve repair, replacement of spare parts, refurbishment and … Continue reading

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