Category Archives: Medical Devices Directive 93/42/EEC

CE marking Directives and the Authorized European Representative

The CE marking is placed on products after compliance with all applicable EU CE marking Directives. Some typical examples of CE marking Directives that F2 Labs provides technical support for are indicated below: Machinery Directive 2006/42/EC  Low Voltage Directive 2014/35/EU … 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, Medical Devices Directive 93/42/EEC, R&TTE Directive 1999/5/EC, Radio Equipment Directive 2014/53/EU | Tagged , , , , , , , , , , , , , , , , | Comments Off on CE marking Directives and the Authorized European Representative

CE markings, Ex markings, and other EU markings claiming product compliance

Manufacturers who build equipment for sale to customers in the European Union may spend a lot of time learning about and understanding the process that is required in order to sell their products with a CE marking on it. Placing … 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 , , , , , , , , , , , , , , , , , , , , , , , , , , , | Comments Off on CE markings, Ex markings, and other EU markings claiming product compliance

Harmonized EN standards, CE marking Directives and your European projects

Silently and slowly – but inexorably… the Directives and standards we use for CE marking are updated, revised, and replaced – and we must account for them. They must be correct when referenced on your declarations of conformity and that … 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, Medical Devices Directive 93/42/EEC, PPE Regulation (EU) 2016/425, Product Testing, R&TTE Directive 1999/5/EC, Radio Equipment Directive 2014/53/EU, RoHS Directive 2011/65/EU | Tagged , , , , , , , , , , , , , , , , | Comments Off on Harmonized EN standards, CE marking Directives and your European projects

The Radio Equipment Directive and the Simplified EU Declaration of Conformity

I first read the new Radio Equipment Directive 2014/53/EU (aka the “RED”) in 2014 when it was published and noted its similarity to the other NLF Framework Directives as it pertains to the documentation compliance process and the conformity modules. … 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, 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 , , , , , , , , , , , , , , | Comments Off on The Radio Equipment Directive and the Simplified EU Declaration of Conformity