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.

On January 10th, regulatory expert Salma Michor, CEO of Michor Consulting EU, will be presenting an audio conference that looks at some of the labeling-related compliance issues faced by medical device manufacturers and the advantages of using e-labeling to gain competitive advantage. Register to attend here:

http://www.fxconferences.com/eLabeling-Medical-Devices-for-the-EU-Market-P597.aspx


ForeignExchange Translations provides specialized medical translations for medical device IFUs, operating manuals, and product labels.