Medical Device Coordination Group has now issued its updated qualification and classification guidelines on software under the MDR, MDCG 2019-11, which will impact broadly on how critical classifications decisions will be made in practice and hence relevant for all operators in the field.
 
In this breakfast seminar we will look at the key news in the guidelines, and review what these will mean for the development and launch of software for medical purposes (SaMD) in the EU.
 
The MDR will mean a significant reclassification of software and other digital products, not the least because most such products will be in class II or higher onwards. Today’s status with a relatively large part of software medical device being in class I thus will undergo a significant change. The MDCG guidance has been long awaited to provide clarification where the lines are drawn between the revised classes and what scope there is for class I classifications of software medical device. In the views of many, there has also been a need for additional guidance on which software will be deemed a medical device at all.
 
In this seminar we will review the key news in the MDCG guideance and what these will mean in practice. We will also go through what news there are on how third party software which is part of another medical device will be dealt with from an MDR perspective. This is not the least with regard to whether such software is in fact a medical device, and thus in most cases would have to undergo class II certification, and what the impact is of the division and clarification of roles laid down in the MDR between manufacturer, importer and distributor.
 
In the seminar we will take a practical approach with the starting point in a couple of relatively common examples. In particular some key measures to be taken to decide the appropriate classification for a software medical device will be dealt with, as will the options allowed under the MDR for “old” classification following the implementation date in May 2020.