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.

MedTech Europe responds to the EU Cybersecurity Act consultation, highlighting key implications for medical device and IVD manufacturers, including certification, vulnerability management, and supply chain security.

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.

ENISA releases NCAF 2.0, a new framework to assess EU cybersecurity capabilities, aligned with NIS2, CRA and DORA, with focus on risk, supply chain and incident response.

EU Delegated Regulation 2026/881 defines when cybersecurity vulnerability and incident notifications may be delayed under the Cyber Resilience Act.

The FDA launches the READI-Home Innovation Challenge to support medical devices aimed at reducing hospital readmissions through home-based care solutions.

The European Commission releases EUDAMED v2.25.2 with new validation rules, certificate controls, and API access. Key implications for medical device manufacturers.

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

MedTech Europe highlights key challenges in the Digital Omnibus, including AI Act timelines, GDPR updates, and Data Act implications for manufacturers.

TGA publishes updated guidance on software-based medical devices. Key regulatory implications for manufacturers supplying SaMD in Australia.

The FDA has issued updated guidance on Clinical Decision Support (CDS) software, clarifying which software functions are excluded from the medical device definition under U.S. law.

The FDA has released a draft guidance outlining new clinical performance requirements for cuffless non-invasive blood pressure devices. Manufacturers using wearable sensors or AI must now meet specific testing standards, including ISO 81060-2. Learn how these updates affect premarket submissions and regulatory strategies.

New FDA guidance clarifies which Clinical Decision Support software functions are not considered medical devices. Key updates affect software developers and manufacturers.

The FDA has updated its guidance on low-risk general wellness devices, clarifying criteria for software, wearables, and lifestyle technologies that may fall outside device regulation. Effective January 6, 2026.

AI in healthcare has transformative potential, but it also raises ethical and regulatory challenges. The WHO has published guidelines on the governance of AI, with a focus on large-scale multimodal models (LMMs). These systems can revolutionize medical diagnosis, scientific research and drug development, but it is essential to guarantee data security, transparency of algorithms and equity of access.

ISO has published new standards and updates for medical devices, health technologies and pharmaceuticals. Among the main standards are requirements for respiratory equipment, risk management in heart valves, cybersecurity in telehealth and digital integration in health. These updates aim to improve the safety, efficacy and regulatory compliance of medical products globally.

The FDA has released a new document on the use of Artificial Intelligence (AI) in the life cycle of medical products, reinforcing the need for transparency, safety and regulatory compliance. The FDA has identified four priority areas: global collaboration to protect public health, support for regulatory innovation, development of standards and best practices, and continuous monitoring of AI performance. The guidelines address everything from algorithm evaluation and bias mitigation to the resilience and cybersecurity of AI-based medical products. This initiative reinforces the FDA's commitment to responsible innovation, ensuring that AI applied to health contributes to medical advances without compromising patient safety.

Regulation (EU) 2025/327 creates the European Health Data Space (EHDS), enabling the secure sharing of medical data and promoting digital interoperability in the European Union. The introduction of the MyHealth@EU platform will ensure the connection between national healthcare systems, making it easier for patients to access their Electronic Health Records (EHRs) and for healthcare professionals in different Member States to use them. In addition, manufacturers of medical devices and in vitro diagnostic devices (IVDs) will have to comply with new security, traceability and interoperability requirements, while digital wellness applications will need a declaration of conformity with European specifications. The first obligations will come into force from March 2027, making it essential for companies in the sector to start preparing to ensure regulatory compliance and access to the European market.

Regulation (EU) 2025/327 establishes the European Health Data Space (EHDS), an innovative system that will enable the secure sharing of health data and cross-border access to Electronic Health Records (EHRs). This initiative strengthens digital interoperability in the European Union, ensuring that citizens can access their medical data in any Member State. For manufacturers of medical devices and digital health applications, the regulation imposes new rules on security, interoperability and data traceability, requiring products claiming compatibility with EHRs to comply with specific standards and, in some cases, to be registered with EUDAMED. The first obligations will come into force from March 2027, making it essential for companies in the sector to start preparing now to ensure regulatory compliance and access to the European market.