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Exporting to Europe and CE Marking
The CE Mark is currently required for many products sold in Europe, yet many U.S. exporters are still unsure or unaware of what affect this has on their business.
QNET has written a guide to provide an easy to understand summary of the EU CE Marking process.
View the publication Exporting to Europe and CE Marking.
The EU Medical Devices Regulation (EU) 2017/745 has been published and can be downloaded here: Medical Devices Regulation
The EU In Vitro Diagnostic Medical Devices Regulation (EU) 2017/745 has been published and can be downloaded here: In-Vitro Diagnostic Devices Regulation
THE QNET LLC Network-Europe consists of QNET BV, The Netherlands, which provides EC Authorized Representative services for CE marked medical devices, IVDD,PPE and machinery. Our Registered design engineers in the United Kingdom write CE marking technical files that comply with the machinery Directive 2006/42/EC, ATEX Directive 94/9/EC, and the Pressure Equipment Directive 97/23/EC.
QNET LLC receives Presidential award for export successes. For the press release click here. .
CE Mark and FDA Consulting Services
QNET LLC assists US Manufacturers with CE marking of medical devices, IVDD, machinery, Pressure Equipment,Personal Protective Equipment and Equipment used in Explosive Atmospheres.
We also specialize in FDA (510k) preparation for U.S. and non-U.S. manufacturers.
RoHS2 Directive 2011/65/EU
RoHS2 is now a CE Marking Directive. In plain English, what this means is that if you manufacture an electrical/electronic product, device or equipment, you can no longer CE mark in accordance with just the Medical Device, Machinery, EMC or Low Voltage Directive. Compliance with the RoHS Directive is required before you can place the CE mark on the product.
Read our publication,"What Manufacturers Need to Know and Do".
New CE Marking Directives for 2016
- Radio Equipment Directive (RED) 2014/53/EU effective 13 June 2016.
- ATEX Directive 2014/34/EU effective 20 April 2016.
- Low Voltage Directive 2014/35/EU effective 20 April 2016.
- EMC Directive 2014/30/EU effective 20 April 2016.
These Directives apply to equipment placed on the market or put into service after those dates.
Download Directives here
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