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FDAnews Device Daily Bulletin
July 10, 2012 | Vol. 9 No. 134
Sweden Seeks Further Clarification on Standalone Software as a Device
Sweden’s Medical Products Agency (MPA) is asking a European Commission working group to address certain issues before adopting a draft guideline on when a stand-alone software program is regulated as a medical device. The draft guideline (MEDDEV 1.2/6), on qualification and classification of device-related stand-alone software, was released in January for public comment. Under the 2007 revision of the medical device directives (MDD), standalone software that the manufacturer describes as having a medical purpose is a device and must be CE marked.
International Medical Device Regulatory Monitor
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