Team-NB, the European Association for Medical Devices of Notified Bodies, has released an updated position paper addressing the implementation and application of the EU Artificial
MedQAIR’s Journey: Founding Story, Mission, and What Sets Us Apart (Q&A) Regulatory compliance in the medical device industry is ever-evolving, especially with the rise of
MedQAIR’s Journey: Founding Story, Mission, and What Sets Us Apart (Q&A) Regulatory compliance in the medical device industry is ever-evolving, especially with the rise of
The European Health Data Space (EHDS) Regulation was published in the Official Journal of the European Union on 5 March 2025 and will enter into
MedQAIR’s Journey: Founding Story, Mission, and What Sets Us Apart (Q&A) Regulatory compliance in the medical device industry can feel like a maze—complex, time-consuming, and
In a move that has taken many in the technology and legal sectors by surprise, the European Commission has withdrawn its proposed AI Liability Directive
The U.S. FDA (Food and Drug Administration) recognized the Common Vulnerability Scoring System (CVSS) v4.0 on December 23, 2024, as a consensus standard for medical
On January 7, 2025, the MDCG 2023-3, a guidance document from the Medical Device Coordination Group (MDCG) of the European Union, was updated to Revision
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.
Here’s a comprehensive overview of the Unique Device Identification (UDI) System as mandated by the EU’s MDR and IVDR regulations.
Cookies help us improve your experience on our website. By using our site, you consent to the use of cookies as described in this policy.
