Four years later, in June 2011, the European Commission issued a draft regulation on e-labeling for medical devices. Then in September 2011, the final draft version of the Regulation was sent for adoption. The draft was adopted in March 2012. Companies have had about 12 months to understand and tease out the implications of the new regulation. As you might expect, the final regulation limits e-labeling to medical devices defined as “professional use only,” along with those accessories also intended for use in specific conditions. The draft is very specific about the conditions in which Instructions for Use (IFUs) may be provided electronically rather than in paper format.
Given the risk-averse medical device industry, the potential for risk tops the list of conditions to watch for when preparing for a change in labeling. The regulation requires a manufacturer to document its risk assessment as a necessary precautionary measure. This risk assessment must demonstrate that the use of electronic instructions will maintain or even improve patient safety compared with paper-formatted IFUs. In fact, the regulation requires the risk assessment be updated further with information and experience gained from the post-market surveillance phase. After documenting the risk assessment, the regulation includes a number of safeguards for the end user, which include: . . .