Some of our device clients maintain IFUs in 30 languages. For many companies, what started out 15 years ago with a handful of languages added to English, labeling has become an entire department, consuming huge resources and time.
It's no wonder then that medical device companies are eager to move towards "e-labeling". The term usually refers to providing Instructions for Use in an electronic format but is bandied about so loosely that it also covers any alternative delivery mechanism - fax on demand, telephone, and so on.
Device companies are excited about the latest revisions to Directive 93/42/EEC and Directive 90/385/EEC. They introduce an amendment to an annex of the directives that will be pivotal for e-labeling, and also for Class IIb and Class III devices. In an upcoming audio conference, Salma Michor will look at some of the labeling-related compliance issues faced by medical device manufacturers and the advantages of using e-labeling.
- EU Labeling for Medical Devices takes a look at e-labeling from the perspective of risk management.
- While geared towards IVD manufacturers, Making instructions for use available in Europe nonetheless contains a good analysis of common labeling approaches.
- MEDDEV 2.14/3 REV 1 [PDF link] started it all.
ForeignExchange Translations provides specialized translations for medical device IFUs, operating manuals, and product labels.