According to the European Medical Device Directive (MDD) amendment of 2010, software is now included in the definition of a medical device. It doesn’t matter if the software is integrated into the actual device or a stand-alone product.
Annex I of Essential Requirement 12.1 now states that software must be validated, taking into account the principles of development lifecycle, risk management, validation and verification.
Given this new attention on software by global regulators, proper medical software localization is now even more important.