In the U.S., IVDs are regulated like other medical devices and divided into one of three classes, each with its own general expectations for a specific type of premarket submission type, based on risk.
Our Emergo by UL expert discusses Breakthrough Device (BTD) and Safer Technologies Program (STeP) designations in this on-demand webinar.
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In this on-demand webinar, our Emergo by UL subject matter expert outlines the latest insights into Brazil’s regulatory updates.
The Malaysia Medical Device Authority released the first edition of its harmonized guidance document on post-market data exchange between ASEAN member states.
The Medical Device Coordination Group (MDCG) published several updated Device Specific Vigilance Guidance (DSVG) documents on January 30.
The FDA final rule sets a two-year timeframe for medical device manufacturers to prepare for compliance to the Quality Management System Regulation that recognizes ISO 13485
The EC proposed extending the transitional provisions for certain IVD devices, following adoption of Regulation (EU) 2023/607, announced January 23.
The EC proposal to delay the compliance of IVDs also proposes a gradual roll-out of the European database on medical devices, EUDAMED. The EC proposes that certain modules of EUDAMED would become mandatory before completing all six modules.
