Please login to the form below

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

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 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.

19th September 2013

Share

Tags

Company Details

Merrill Brink International

353-(0)91-393000

Contact Website

Address:
Unit 2 Ballybrit Business Park
Galway
Ireland

Latest content on this profile

Pharmacovigilance and adverse event reporting: Five keys for establishing worldwide best practice
Pharmacovigilance, an arm of patient care with a charter to make the best use of medicines and data for the treatment or prevention of disease, is taking on growing importance in global public health.
Merrill Brink International
Ensuring you are EU Medical Device e-labelling compliant - A best practice strategy
The EU Directive No 207/2012 on electronic labelling for Instructions for Use (IFUs) for certain medical devices was adopted effective March 9, 2012.
Merrill Brink International
Seven tips to get the most out of your relationships with translation partners
The most effective translation and localization strategies align the best people, processes and technology to deliver multilingual content.
Merrill Brink International
Life Sciences Translations – Five steps to choosing the most effective language services partner
Companies in the life sciences industry face a particularly tough set of challenges in bringing products to the global marketplace, not least of which is delivering multilingual content.
Merrill Brink International