Pharmafile Logo
T40 2022 Cover
Diversity, Equity and Inclusion
Communiqué 53 Cover Image
- PMLiVE

Ensuring you are EU Medical Device e-labelling compliant – A best practice strategy

September 19, 2013 | Merrill Brink 

The EU Directive No 207/2012 on electronic labelling for Instructions for Use (IFUs) for certain medical devices was adopted effective March 9, 2012.

- PMLiVE

The EU Directive No 207/2012 on electronic labelling for Instructions for Use (IFUs) for certain medical devices was adopted effective March 9, 2012. The regulation provides an allowance for medical device manufacturers to choose electronic labelling or e-labelling of IFUs for these devices. Companies that choose this option need to have complied by March 1, 2013. 

The regulation puts the onus on manufacturers to determine which of their products are good candidates for e-labelling. 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?

Click here to download the free whitepaper ‘Best Practices to Ensure Compliance with EU Medical Device Directive Regulations on e-Labelling’  to get a real understanding of strategies to ensure compliance and also to ensure you are best positioned to capture market share.

This content was provided by Merrill Brink International