Day

May 23, 2005
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...
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The EU issued a proposal to modify the MDD. This proposal expresses several suggestions related to software. The full text is at the link provided. EU proposal for revision of MDD
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