The EU is now close to release of a revision of the Medical Device Directive (MDD). The full text with change marks is at the link provided. The MDD has expanded clause 12.1 into an (a) and (b) sub-clause with the latter specifically addressing software and the former being the original 12.1. The text of this clause is:
“12.1b For devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principals of development lifecycle, risk management, validation and verification.”
This clause makes it clear that testing alone is insufficient.
In addition, Section 1.4 for Active Medical Devices states:
“Software (whether standalone or being part of a medical device) is considered to be an active medical device.”