LIVE — Last crawled: 2026-05-07 17:57 JST
Vol.1 — May 8, 2026
MSC Portal Regulatory Watch All Entries (128)
Standards, Guidance & Notices
Showing 11–20 of 128
CEN/
CENELEC
EN ISO 18562-1:2024
EN ISO 18562-1:2024 Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 1: Evaluation and testing within a risk management process
PUBLISHED NEW Risk Management
This newly established harmonized standard under EU MDR addresses biocompatibility evaluation specifically for medical devices with breathing gas pathways, such as ventilators and anesthesia delivery systems. The document provides comprehensive methodology for assessing biological safety of materials and substances in contact with respiratory gases through a risk management framework. Manufacturers should evaluate the biocompatibility potential of device materials and their extractables using appropriate biological testing and chemical analysis methods proportionate to patient exposure duration and conditions. The standard specifies evaluation strategies, test selection criteria, and acceptance criteria for breathing gas pathway components. Requirements apply to all devices intended to deliver or facilitate breathing gas therapy or anesthesia. This standard was published in the EU Official Journal via Decision 2026/193.
Published: 2026-01-28
JFMDA
Notice
jaame-committee-ai
Review of Regulatory Approval for AI-Enabled Software as a Medical Device: Study Results Report (English Translation)
PUBLISHED NEW AI / Machine Learning
English translation of the August 2025 report on regulatory review procedures for AI-enabled SaMD. This translated version facilitates international understanding of Japanese regulatory considerations for AI-integrated medical device software.
Published: 2026-01-22
JFMDA
Notice
committee-fuguai
Utilization of Medical Device Adverse Event Terminology Glossary
PUBLISHED NEW SaMD Classification
JFMDA updated the Medical Device Adverse Event Terminology Glossary, revising individual terminology lists to harmonize with IMDRF adverse event terminology standards and improve consistency across regulatory definitions.
Published: 2026-01-09
AAMI
TIR
AAMI CR515:2025
AAMI CR515:2025 - Cybersecurity Considerations Specific to Machine Learning-enabled Medical Devices
PUBLISHED NEW Cybersecurity
AAMI CR515:2025 establishes cybersecurity considerations specific to machine learning-enabled medical devices. Recognized by the FDA as a consensus standard (Recognition Number: 13-153) on December 22, 2025, the document serves as a normative reference in the Software/Informatics domain. The standard specifies security risk management requirements essential for the development and operational deployment of medical devices incorporating artificial intelligence and machine learning technologies. Manufacturers should implement the specified cybersecurity controls and risk management procedures to address vulnerabilities introduced by machine learning algorithms, including model drift, adversarial attacks, and data integrity threats. The document provides manufacturers with practical guidance for integrating cybersecurity considerations throughout the device lifecycle, from initial algorithm development through post-market surveillance and model updates.
Published: 2025-12-22
NIST
CSWP
CSWP 34
Mitigating Cybersecurity and Privacy Risks in Telehealth Smart Home Integration
PUBLISHED NEW Risk Management
In-patient service demands have increased during a time when patients have experienced reduced access to hospital care. Hospital-at-Home (HaH) solutions are a form of telehealth that provide an in-patient care experience in patients’ homes, offering the potential for improved outcomes. While these are desirable benefits, HaH involves privacy and cybersecurity risks by introducing hospital-grade medical or biometric devices and information systems outside the hospital’s direct control (i.e., the patient’s home). Patient homes increasingly feature Internet of Things (IoT) devices, such as voice assistants (e.g., smart speakers), as part of a broader “smart home” ecosystem. These devices may not have capabilities that support privacy and security practices and may be used as pivot points for attackers to gain access to a hospital’s information system. This paper introduces a notional high-level smart home integration reference architecture to better un
Published: 2025-12-17
JFMDA
Notice
jaame-committee-windows-2
Alert Regarding Windows Secure Boot Certificate Expiration
PUBLISHED NEW Cybersecurity
Alert notification for medical device manufacturers using Windows Embedded 8 Standard or later with Secure Boot functionality regarding impending security certificate expiration and required remedial actions.
Published: 2025-09-29
JFMDA
Notice
committee-AI
Review of Regulatory Approval for AI-Enabled Software as a Medical Device: Study Results Report
PUBLISHED NEW AI / Machine Learning
JFMDA Legal Affairs Committee's AI-enabled SaMD Regulatory Review Working Group published comprehensive research findings beginning October 2022, examining regulatory pathways and approval considerations for AI-integrated medical device software.
Published: 2025-08-27
EU
MDCG
MDCG 2025-6
FAQ on Interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA)
PUBLISHED NEW AI / Machine Learning
MDCG 2025-6 — FAQ on Interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA) — (June 2025)
Published: 2025-06-01
EU
MDCG
MDCG 2025-4
Guidance on the safe making available of medical device software (MDSW) apps on online platforms
PUBLISHED NEW AI / Machine Learning
MDCG 2025-4 — Guidance on the safe making available of medical device software (MDSW) apps on online platforms — (June 2025)
Published: 2025-06-01
EU
MDCG
MDCG 2019-11 rev.1
Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746
PUBLISHED NEW AI / Machine Learning
MDCG 2019-11 rev.1 — Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746 — (June 2025)
Published: 2025-06-01
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