Best Practices to Ensure Compliance with EU Medical Device Directive Regulations on e-Labeling

Jan. 10, 2013 - PRLog -- St. Paul, Minn. — Merrill Brink International (www.merrillbrink.com), a leading global provider of language solutions for global companies and law firms (http://www.merrillbrink.com/language-services.htm), 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 March 9, 2012. The regulation provides an allowance for medical device manufacturers (http://www.merrillbrink.com/medical-device-and-diagnostic-translation.htm) to choose electronic labeling or e-labeling of IFUs for these devices. Companies that choose this option need to be prepared to comply by March 1, 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:

·         When in the development process do you initiate the information for usage?

·         How and where is product content stored and updated? Is it centralized on one platform?

·         How are updates to content currently managed? Will this methodology work efficiently for EU requirements?

·         Do you have a workflow in place that can be scaled to accommodate 23 languages?

Download Merrill Brink's white paper “Best Practices for e-Labeling Compliance” (http://www.merrillbrinkdeal.com/TRL-Pros-16?LeadSource=In...) and find out the plan of action to ensure compliance with EU medical device directive regulations on e-Labeling. Companies that take steps now to understand the EU's e-labeling requirements will be best positioned to capture market share.

Full Text: http://www.merrillbrink.com/white-paper-best-practices-for-elabeling-compliance-01072013.htm

Download here: http://www.merrillbrinkdeal.com/TRL-Pros-16?LeadSource=Internet_Advertising&CampaignID=701C0000000hdTh

About Merrill Brink International

Merrill Brink International (www.merrillbrink.com) is a leading provider of complete translation and language solutions for global companies and law firms, with special expertise in serving the legal, financial, life sciences, software, heavy machinery and corporate markets. A proven leader with more than 30 years of experience, Merrill Brink offers a wide range of language solutions including translation, localization, desktop publishing and globalization services.

Merrill Brink is recognized in the industry for its commitment to quality and its pioneering approach of leveraging technology to reduce costs, eliminate redundant processes and accelerate translation life cycles. Merrill Brink is certified to ISO 9001:2008; ISO 27001:2005 and ISO 13485:2003, and registered to EN 15038:2006 and ISO 14971:2007. Together, these standards provide assurance that the most stringent process and quality standards for translation are followed. Merrill Brink International is a wholly owned subsidiary of Merrill Corporation.