Breakthrough medical device (BtMD)
a medical device, not being an in vitro diagnostic medical device, that qualifies as breakthrough per section 4 of this guidance
MDCG 2025-9, Section 1, Abbreviations and Terminology
a medical device, not being an in vitro diagnostic medical device, that qualifies as breakthrough per section 4 of this guidance
MDCG 2025-9, Section 1, Abbreviations and Terminology