The EU issued proposed new text for the Medical Device Directive (MDD). The document with highlighted revisions, additions, and deletions is at the link provided. The proposed changes include several additions to more explicity address software. These include adding:
- the word “software” into the definition of a medical device in section 2(a)
- Annex I 12.1b Page 10 “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.”
- Annex IX 1.4 Page 26 “… Software (whether standalone or being part of a medical device) is considered to be an active medical device.”