London,UK (PRWEB UK) 11 January 2013
Galway, Ireland Merrill Brink International (http://www.merrillbrink.com), a leading global provider of language solutions for global companies and law firms, today announced that it has published a new white paper, Best Practices to Ensure Compliance with EU Medical Device Directive Regulations on e-Labeling.
The EU Directive No 207/2012 on electronic labeling for Instructions for Use (IFUs) for certain medical devices has been adopted effective 9 March 2012. The regulation provides an allowance for medical device manufacturers to choose electronic labeling or e-labeling of IFUs for these devices. Companies that choose this option need to be prepared to comply by 1 March 2013. The regulation puts the onus on manufacturers to determine which of their products are good candidates for e-labeling. Manufacturers should perform a detailed, documented risk assessment to identify any areas of potential risk and any additional investment required to achieve compliance. The white paper addresses the following questions: