EU MDD Revision Draft – Software Additions

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.”

MDD Software Additions 2005 Public Consultation Draft

Need Your Input!

We have been researching where and when to hold our next 3-day 62304/FDA training course and we want your feedback!
1) Does the location in the US for a public course matter to you … for example, west coast (e.g., San Francisco area) vs. east coast (e.g., Boston)?
2) What locations do you prefer?
3) Would you prefer just the 3-day FDA/62034 course or to have the option of a full week 3-day course followed by cybersecurity 1-day, and a usability 1-day?
4) What other countries would you want to see our course offered publicly?
5) What are best two months of the year for the course?  What are the least favored (not workable) months?
Please respond by email to

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