Episode 118

Implementing Changes to SaMD under New EU MDR

Classification, qualification, and other changes to Software as a Medical Device (SaMD) under the new European Medical Device Regulation (EU MDR) continue to create angst and uncertainty. In this episode, Andrew Wu and I discuss the ramifications of these changes. Andrew is a software consultant with Rook Quality Systems and software as a medical device (SaMD) expert. Some of the highlights of the show include: ● Most noticeable change is a broader definition of what qualifies as a medical device to include prediction and prognosis of diseased state. ● SaMD classification changes are drastic but vague following MDR implementation. ● Gap analysis should be performed to identify changes that companies need to make to conform with changes. ● Groups that will most likely experience the greatest impact due to classification and qualification changes: ○ Products on market in EU as Class I software will be uplisted as Class IIa. ○ Products that provide clinical information for informed clinical decisions. ● Timeline and Some Next Steps: Demonstrate conformance, update quality management system (QMS), notify regulatory body to MDR by May 25, 2020. ● Plan, prioritize, and understand your regulatory conformance strategy going forward. ● Compare and Contrast EU MDR and US FDA: Developing regulatory framework in different directions, but share consensus on sensitive nature and usage.

About the Podcast

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Global Medical Device Podcast powered by Greenlight Guru
The Global Medical Device Podcast, powered by Greenlight Guru, is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts ...

About your host

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Etienne Nichols

Mechanical Engineer, Medical Device Guru, and host of the Global Medical Device Podcast