Impact of MDD/2007 on Medical Device Companies

Attention technical writers, regulatory specialists, and localization coordinators! If your company designs, manufactures, or re-packages medical devices with any type of software intelligence or user interface— listen up. Come March 21, 2010, your job complexity will get better and worse, thanks to changes in Medical Device Directive (MDD) standard 2007/47/EC.

Currently recognized as “voluntary”, MDD 2007/47/EC becomes mandatory law in March of next year. Because the Federal Food and Drug Administration (FDA) recognizes MDD standards as guidance for US law, anyone with a domestic or international customer base is impacted by this new standard. Changes in two key areas are relevant to individuals managing medical device/medical product documentation (user manuals and instructions for use [IFUs]), labeling, and product packaging.