MedTech Europe has published its position on the MDR/IVDR revision, supporting simplification measures while warning about new burdens for manufacturers, AI compliance challenges, cybersecurity reporting, and single-use device reprocessing.

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 EDPB publishes a new 2026 DPIA template to standardise GDPR compliance. What it means for medical device manufacturers.

The EU Cyber Resilience Act is reshaping GMP expectations for laboratories. Learn how cybersecurity, data integrity, and validation requirements will impact manufacturers.

FDA issues final guidance on cybersecurity in medical devices, outlining QMS, premarket documentation, and Section 524B requirements for manufacturers.

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 new Revision 3 of NIST SP 800-61, published in April 2025, redefines incident response as an integral part of cyber risk management, now aligned with the Cybersecurity Framework 2.0. The guide covers everything from preparation and detection to recovery and continuous improvement. Smart MDR supports medical device manufacturers and SaMDs in implementing incident response processes in line with the requirements of the MDR, IVDR, FDA and international standards such as NIST.

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.