Are You Prepared? – Free White Paper from Merrill Brink International and AdvaMed

Best practices to insure compliance with EU Medical Device 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. 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. Can you answer any or all of these 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” 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.

Registration required – Download Paper Here


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