Implementing Changes to SaMD under New EU MDR - a podcast by Greenlight Gurus Jon Speer + Medical Device Quality Regulatory Leaders, Entrepreneurs, Consultants, R&D Engineers
from 2019-11-07T15:06:50
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.
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