Anvisa has launched Call Notice 5/2026 to select up to 10 innovative medical device projects for regulatory evaluation and continuous dialogue in Brazil.

The TGA has updated its guidance on how medical device applications are selected for audit before inclusion in the ARTG, including mandatory audits, non-mandatory audit criteria, regulatory reforms, UDI and post-market signals.

MHRA releases its AI Airlock Sandbox Phase 2 report, detailing regulatory insights on AI validation, PCCPs, generative AI, and real-world PMS.

European Union publishes Regulation (EU) 2026/1744 (Digital Omnibus on AI), amending the EU AI Act to streamline compliance, adjust timelines, and relieve SMEs.

NIST has published a news release on a mathematical proof supporting the transition from a “one and done” AI security model to continuous monitoring and updating.

The European Commission has published an unofficial consolidated version of the AI Act incorporating the Digital Omnibus amendments, providing an updated reference for manufacturers and other stakeholders.

ANVISA has launched a public call for contributions to support the revision of Brazil's medical device vigilance regulatory framework, seeking feedback from medical device registration holders on post-market surveillance requirements and future regulatory developments.

A new European Parliament briefing provides an overview of the EU Artificial Intelligence Act, including its risk-based framework, implementation timeline, and key provisions relevant to AI systems, including those used in medical devices.

The FDA has classified radiological machine learning-based quantitative imaging software with predetermined change control plans as Class II medical devices, establishing special controls to support the safe development and regulatory oversight of AI-enabled imaging software.

The MHRA has published the Phase 2 report of its AI Airlock programme, highlighting regulatory challenges related to AI medical devices, AI-powered IVDs, performance evaluation, post-market surveillance and lifecycle change management.

The European Commission has released Version 3 of its Living Guidelines on the Responsible Use of Generative AI in Research. Learn what the new recommendations mean for medical device manufacturers, clinical evaluation, data protection and research activities.

The EU Council and Parliament reached a provisional agreement to simplify the AI Act, including delayed deadlines for high-risk AI systems and clarifications for manufacturers.

FDA opens consultation on a pilot program to assess artificial intelligence in early-phase clinical trials, focusing on efficiency, safety, and decision-making.

EU Parliament adopts AI Act simplification package. Key changes impact high-risk AI timelines, MDR alignment, and compliance requirements.

The AI Airlock initiative, launched by the MHRA, is an innovative regulatory sandbox designed to support the development and evaluation of Artificial Intelligence medical devices (AIaMD). This controlled regulatory environment allows manufacturers of AI-based medical technology to test compliance approaches, clinical evidence and algorithmic validation prior to formal submission. With a focus on adaptive machine learning models, algorithmic security and continuous monitoring, AI Airlock represents a strategic opportunity to accelerate market access with UKCA compliance.

The new revised version of the MDCG 2019-11 (Rev.1) clarifies the qualification and classification of software as a medical device (MDSW ) and in vitro diagnostic software (IVD), in the context of the MDR and IVDR. The document covers classification rules, integration with AI Act and EHDS, and includes practical and up-to-date examples. Smart MDR supports MDSW manufacturers in managing compliance and technical documentation.

The new MDCG 2025-6 guide, published in June 2025, clarifies the joint application of the AI Act and the European MDR/IVDR regulations for medical devices and IVDs with artificial intelligence systems. The document addresses classification, risk management, life cycle, technical documentation and post-market monitoring. Smart MDR supports manufacturers in integrating these requirements into their quality management system and preparing for audits.

The European Union's AI Act establishes new legal obligations for all organizations that develop or use artificial intelligence systems. Article 4 of the AI Act, applicable since February 2, 2025, requires companies to ensure an adequate level of AI literacy among their employees and service providers.

The recent completion of the FDA's artificial intelligence-supported pilot project marks an important step in the modernization of scientific review processes. With the promise of speeding up evaluations and reducing repetitive tasks, the FDA plans to implement generative AI across the board by June 2025.

Team-NB 's official position paper on the implementation of the AI Act offers key guidance for manufacturers of medical devices with artificial intelligence. The document analyzes the integration between the AI Regulation and the requirements already established by the MDR and IVDR, underlining the classification of devices with AI as high-risk systems.