Medical Translation Insight

Medical device labeling in the EU continues to pose a challenge for manufacturers, who must create compliant Instructions for Use in all required languages. The term "e-labeling" refers to innovative means for providing Instructions for Use in an electronic format for medical devices.

Originally e-labeling focused on IVDs, since these are usually used by healthcare professionals in a clinical environment, however, the latest proposed revisions to Directive 93/42/EEC and Directive 90/385/EEC introduce amendments pivotal for e-labeling for other devices.

In order to set up an e-labeling system, companies must develop and implement internal controls and procedures that promote adherence to regulatory requirements including applicable statutes, laws, regulations and directives. E-labeling provides several advantages in managing regulatory compliance but also poses some challenges.

We've prepared a white paper that discusses the challenges of EU e-labeling. In the paper, we look at some of the labeling-related compliance issues faced by medical device manufacturers and the advantages of using e-labeling to gain competitive advantage. Download it here:

http://info.fxtrans.com/medical-devices-e-labeling-for-the-eu-market-mcn


ForeignExchange Translations provides specialized medical translation services to the world's leading pharmaceutical and medical device companies.