EU MDD Revision Ready – New Software Clauses

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.”

EU MDD 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

office@softwarecpr.com by Sep 25, 2019 if possible!

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