CE Mark Medical Device Custom Labels

Are you a manufacturer of medical devices or other products and looking to export to the Europe Union.  If so, you have probably heard about the CE mark medical device manufacturers must have displayed on their products.  At Data Graphics, we are constantly looking for ways to improve our services and efficiency to better serve our customers.  To this end, we have identified ways to broaden the range of services we offer, by attaining and maintaining certifications to allow us to produce labels, graphic overlays, stickers and other products.  In addition to our Underwriters Laboratory certification, AS 9100 certification, ISO 9001:2000 certification and ITAR registration, we can now offer our customers, who export their products to Europe, the benefit of our registered compliance with the European Union’s RoHS 2002/95/EC Directive.  This compliance certifies that Data Graphics does not employ, in the production of the labeling and other products we offer to our customers, products containing unacceptable levels of certain hazardous materials, such as heavy metals and polybrominated biphenyls (PBB).

The labeling of any medical device intended for export to European Union nations must bear the CE mark.  Medical device manufacturers will find it very difficult to find customers in Europe willing to purchase their products without this CE mark.  Medical device consumers in Europe expose themselves to a great deal of legal liability if they are found to be using medical equipment that is not in compliance with the European Union’s requirements for medical equipment and, therefore, does not carry the CE mark.  Medical device manufacturers from the United States that do not export their equipment to the European Union countries have to ensure that their medical equipment or devices comply to the standards of the U.S. Food and Drug Administration – the CE mark medical device manufacturers use serves to show that they are in compliance with the European Union’s several versions (each nation will have their own) of the FDA.

 Labeling, overlays and nameplates for medical devices all come with their own challenges. At Data Graphics, we have more than twenty five years of successful experience working with our customers in the medical technology field.  Our knowledgeable customer service professionals can suggest products made from a variety of materials and employ different finishes and printing methods to ensure that your custom labels, overlays, stickers or nameplates lasts as long as your product does. 

 Additionally, you have the confidence that comes with dealing with a RoHS 2002/95/EC compliant vendor when you need custom labels for your CE mark medical device.  Contact us today to see what Data Graphics can do to meet your medical device labeling needs.