ARTICLE SUMMARY:
In this week's top news pick from MedTech Strategist Market Pathways: Europe unveils long-awaited guidance on how software fits into its new medical device and diagnostic regulatory schemes, just about two weeks after FDA issued related guidelines.
[For a complete roundup of medtech policy happenings that should be on your radar this week and deeper analysis of the sector, check out Market Pathways.]
Device regulators around the world have been issuing more and more guidance explaining the types of medical software that will require review before market launch, but one big information gap has been in Europe.
The EU system is moving toward a major expansion in its oversight of medical software under the oncoming Medical Device and IVD Regulations, but a full understanding of how the new authorities will be leveraged has been missing. On Friday, Europe’s Medical Device Coordination Group, which is implementing the new regulations, finally posted a document laying out how to determine which types of software will qualify for regulation under the MDR and IVDR and how they will be risk-classified within the system. (A lot of software that may currently be Class I will be higher risk under MDR/IVDR and require notified body sign off for the first time.) The guidance includes decision-making flowcharts and multiple specific software examples.
The EU document comes about two weeks after US FDA issued its own guidelines, including one clarifying which types of software will no longer sit under FDA’s authority (as a result of the 21st Century Cures Act ) and a revised draft laying out expectations for one of the most popular types of standalone regulated software: clinical decision support (CDS) systems. There is one noteworthy similarity between EU’s new document and the FDA CDS draft: they both leverage risk classification categories established for “software as a medical device” (SAMD) by the International Medical Device Regulators Forum. Hopefully, that signals there will be a more harmonized approach on the two sides of the Atlantic going forward.
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