On June 18, 2025, the EU Medical Device Coordination Group (MDCG) released MDCG 2025-5, a detailed Q&A document clarifying the rules for in vitro diagnostic
On May 5, 2025, the European Commission published version 7.3.1 of the Manufacturer Incident Report (MIR) form, along with accompanying help text, XSD/XSL files, and
The International Organization for Standardization (ISO) is preparing a revision of ISO 10993-1, the critical standard governing the biological evaluation of medical devices. This update
Navigating the e-QMS Landscape: Insights from the European SaMD Meetup Ivo Flipse from MedQAIR co-hosted the European SaMD Meetup alongside Lara Rashdan from hema.to. In
South Korea’s Ministry of Food and Drug Safety (MFDS) announced on January 24th that it has released the first-ever guidelines for the approval and assessment
On Wednesday, the International Medical Device Regulators Forum (IMDRF) finalized two highly anticipated technical documents outlining guiding principles for good machine learning practices (GMLP) and
The United States Food and Drug Administration (FDA) released a draft guidance document on January 6, 2025, outlining its recommendations to facilitate the development and
Compliance with the Medical Device Regulation (MDR) and In-Vitro Medical Regulation (IVDR) is crucial in the complex and highly regulated medical device landscape of the
Today marks a milestone for the EU as the AI Act enters into force after three years of development. The EU leads as the first to establish a robust AI regulatory framework. With the countdown for implementation beginning, let’s explore the timelines ahead.
Today marks a milestone for the EU as the AI Act enters into force after three years of development. The EU leads as the first to establish a robust AI regulatory framework. With the countdown for implementation beginning, let’s explore the timelines ahead.
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