Ensuring compliance with EU medical device directive regulations on e-labeling
Merrill Brink International, a global provider of language solutions for global companies and law firms, has announced that it has published a new white paper, “Best Practices to Ensure Compliance with EU Medical Device Directive Regulations on e-Labeling.”
Merrill Brink International, a global provider of language solutions for global companies and law firms, has 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 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?
Companies that take steps now to understand the EU's e-labeling requirements will be best positioned to capture market share. You can download the report from the Merrill Brink website and find out the plan of action to ensure compliance with EU medical device directive regulations on e-Labeling.