Category Archives: CE marking

RoHS Directive 2011/65/EU – Article 4 (3) – expired

The RoHS Directive 2011/65/EU, Article 4 (3) exclusion for industrial monitoring and control instruments expired on Saturday, July 22, 2017. That exclusion was used by quite a few manufacturers to delay RoHS compliance, but Article 4 (3) is now gone. … Continue reading

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Safety Components and the Machinery Directive 2006/42/EC

From time to time we are presented with a device that seemingly “fits” into the Low Voltage Directive 2014/35/EU because it only has electric function and no moving components. This would lead most to apply the Low Voltage Directive instead … Continue reading

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CE marking and the ATEX Directive 2014/34/EU

Many times, we receive a request for assistance from a customer for a project that involves, “CE marking and ATEX.” While there is nothing wrong with calling ATEX out separately from other CE marking requirements, we note that the ATEX … Continue reading

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The EU declaration of conformity

A frequent source of confusion for exporters of products to the EU is the EU declaration of conformity. Many customers that we assist are vaguely familiar with the concept and the role of the “DoC”. The EU declaration of conformity … Continue reading

Posted in ATEX Directive 2014/34/EU, CE marking, EMC Directive 2014/30/EU, EN 60601-1, General Product Safety Directive 2001/95/EC, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Medical Devices Directive 93/42/EEC, PPE Regulation (EU) 2016/425, Pressure Equipment Directive 2014/68/EU, Product Testing, R&TTE Directive 1999/5/EC, Radio Equipment Directive 2014/53/EU, RoHS Directive 2011/65/EU | Tagged , , , , , , , , , , , , , , , | Leave a comment

CE marking and the Technical File

Manufacturers who send equipment into the EU are required to send a CE compliant product in most cases. This means that if you are making an electromechanical device, chances are that you will need to comply with at least one, … 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, Medical Devices Directive 93/42/EEC, PPE Regulation (EU) 2016/425, Pressure Equipment Directive 2014/68/EU, Product Testing, R&TTE Directive 1999/5/EC, Radio Equipment Directive 2014/53/EU, RoHS Directive 2011/65/EU | Tagged , , , , , , , , , , , , | Leave a comment

Repeal of the Affordable Care Act and the Medical Device Tax

Yesterday afternoon, March 6th, the House Republicans released the bill to repeal (most of) the Affordable Care Act, also known as Obamacare. Since F2 Labs is a safety compliance laboratory, helping many companies comply with regulatory issues when bringing their … Continue reading

Posted in EN 60601-1, Medical Devices Directive 93/42/EEC, Product Testing | Tagged , , , , , , | Leave a comment

Lasers, IEC/EN 60825-1, the Low Voltage Directive 2014/35/EU, and the General Product Safety Directive 2001/95/EC

Laser devices sent to Europe are subject to specific safety requirements. Some of these requirements are applicable even if the rest of the device is seemingly innocuous. To start with, we will present a case where a device appears to … Continue reading

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The Machinery Directive 2006/42/EC and lifting accessories

The Machinery Directive 2006/42/EC, broadly, is applicable to machinery, defined in Article 2 (a) as an assembly fitted or intended to be fitted with a drive assembly to perform a function. The power, unless used for lifting purposes, must come … Continue reading

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New RoHS restrictions, substances added to Annex II

There is a change on the horizon for manufacturers used to complying with RoHS based on the restriction of the six substances indicated in RoHS 2011/65/EU (Annex II): Lead (0.1%) Mercury (0.1%) Cadmium (0.01%) Hexavalent chromium (0.1%) Polybrominated biphenyls (PBB) … Continue reading

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Compliance with the Low Voltage Directive 2014/35/EU, Annex I

F2 Labs is constantly working to help customers better understand their responsibilities in complying with CE marking Directives that may or may not apply to their equipment. Previously we published an article about the relationship between the Low Voltage Directive 2014/35/EU … Continue reading

Posted in CE marking, Low Voltage Directive 2014/35/EU, Product Testing, R&TTE Directive 1999/5/EC, Radio Equipment Directive 2014/53/EU | Tagged , , , , , , , , , , , , , | Leave a comment