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Vol.1 — August 14, 2026
MSC Portal Regulatory Watch All Entries (146)
Standards, Guidance & Notices
Showing 41–50 of 146
NIST
SP
SP 800-63B-4
Digital Identity Guidelines: Authentication and Authenticator Management
PUBLISHED NEW Cybersecurity
This guideline focuses on the authentication of subjects who interact with government information systems over networks to establish that a given claimant is a subscriber who has been previously authenticated. The result of the authentication process may be used locally by the system performing the authentication or asserted elsewhere in a federated identity system. This document defines technical requirements for each of the three authenticator assurance levels. The guidelines are not intended to constrain the development or use of standards outside of this purpose. This publication supersedes NIST Special Publication (SP) 800-63B.
Published: 2025-07-31
NIST
SP
SP 800-63C-4
Digital Identity Guidelines: Federation and Assertions
PUBLISHED NEW Cybersecurity
This guideline focuses on identity federations and the use of assertions to implement them. Federation allows a given credential service provider to provide authentication attributes and (optionally) subscriber attributes to a number of separately administered relying parties. Similarly, relying parties may use more than one credential service provider. These guidelines are not intended to constrain the development or use of standards outside of this purpose. This publication supersedes NIST Special Publication (SP) 800-63C.
Published: 2025-07-31
ISO
ISO/IEC 42006:2025
Information technology — Artificial intelligence — Requirements for bodies providing audit and certification of artificial intelligence management systems
PUBLISHED NEW AI / Machine Learning
Specifies requirements for bodies providing audit and certification of AI management systems conforming to ISO/IEC 42001. Forms the foundation for AI conformity assessment schemes. Referenced in the context of EU AI Act harmonized standards development.
Published: 2025-07-07
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 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 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 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
ISO
ISO/IEC 42005:2025
Information technology — Artificial intelligence — AI system impact assessment
PUBLISHED NEW AI / Machine Learning
Specifies processes and requirements for assessing the impacts of AI systems on society, individuals and the environment. Intended for use in conjunction with ISO/IEC 42001. Serves as a framework for impact assessment in medical AI development.
Published: 2025-05-28
EU
MDCG
MDCG 2020-16 rev.4
Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
PUBLISHED NEW SaMD Classification
MDCG 2020-16 rev.4 — Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 — (March 2025)
Published: 2025-03-01
IMDRF
IMDRF/SaMD WG/N81 FINAL:2025
Characterization Considerations for Medical Device Software and Software-Specific Risk
PUBLISHED SaMD Classification
Presents considerations for characterizing medical device software and identifying software-specific risk factors. Explains how software characteristics such as function, complexity and interconnectivity relate to the risks they introduce, enabling manufacturers and regulators to apply proportionate risk management and regulatory approaches.
Published: 2025-01-29
IMDRF
IMDRF/AIML WG/N88 FINAL:2025
Good machine learning practice for medical device development: Guiding principles
PUBLISHED AI / Machine Learning
Sets out guiding principles for the safe and effective use of machine learning in medical device development. Covers data quality management, the model development process, verification and validation, and ongoing performance monitoring, to help ensure the reliability and performance of machine learning systems.
Published: 2025-01-29
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