Standards, Guidance & Notices
Showing 11–20 of 134
ISO
ISO/TS 24971-2:2026
Medical devices — Guidance on the application of ISO 14971 — Part 2: Machine learning in artificial intelligence
Provides guidance on risks specific to artificial intelligence and machine learning, and on how to apply the risk management process of ISO 14971 to machine learning-enabled medical devices (MLMD). Intended to be used in conjunction with ISO 14971 and does not alter its requirements.
Published: 2026-06-17
MHLW
Notice
Notice
MHLW-PFSB-MDED-0615-No.1
Pilot Implementation of Prioritized Review and Other Measures for Software as a Medical Device and Related Products (MHLW Notice No. 0615-1, June 15, 2026)
MHLW notice continuing the pilot of prioritized review for software as a medical device (SaMD), conducted since FY2022 following a June 2022 Cabinet decision on the New Capitalism action plan, by setting designation requirements and accepting applications on a rolling basis. Eligible products are SaMD and physical medical devices with SaMD-equivalent program functions; products seeking approval under the rebalancing notice or the two-stage approval notice are excluded. All three requirements must be met: (1) innovativeness of the treatment, diagnostic or preventive method (programs that deliver content equivalent to clinical patient guidance to prompt behavior change at home are, in principle, not considered innovative); (2) medical usefulness for the target disease; and (3) intent and capability to file in Japan first or simultaneously (within three months), using the PMDA SAKIGAKE comprehensive evaluation consultation. Designated products receive priority consultation, priority review under Article 23-2-5, paragraph 10 of the PMD Act, coordination by a concierge, and eligibility for the support program for consultation and applications for innovative medical devices, with the aim of shortening the review period to six months or less after adequate pre-submission evaluation. The procedure runs from registration, hearing and preliminary screening to formal application and PMDA evaluation, with results reported to the Pharmaceutical Affairs Council and then published. Conditions for revoking designation are also specified.
Published: 2026-06-15
FDA
CDRH
CDRH
fda_20260528_human_factors
Content of Human Factors Information in Medical Device Marketing Submissions
Final guidance issued by FDA CDRH on May 29, 2026 (finalizing the December 2022 draft) that provides a risk-based framework for the human factors information to include in 510(k), De Novo, PMA and HDE submissions; combination products are not addressed. Submitters determine one HF Submission Category per submission using a flowchart based on the use-related risk analysis (URRA): whether the device is a modification; whether the user interface, intended users, uses, use environments, training or labeling change; whether there are critical tasks (new or impacted, for modified devices); and whether human factors validation data are needed given the user interface history of use, its complexity and the adequacy of existing risk controls. Category 1 calls for a conclusion and high-level summary; Category 2 adds a rationale and descriptions of users, uses, environments, training, the user interface and known use problems; Category 3 calls for a full HFE/UE report including the URRA, critical tasks and human factors validation testing. Worked examples are included; for instance, a change to a computer-assisted detection algorithm with no user interface change falls into Category 1. The guidance is a companion to Applying Human Factors and Usability Engineering to Medical Devices. FDA generally does not anticipate the newly recommended information in submissions pending at publication or received before August 1, 2026. Docket FDA-2015-D-4599.
Published: 2026-05-29
EU
MDCG
MDCG
Borderline Manual
Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v5
Version 5 (April 2026) of the manual recording agreements reached by the competent authorities of the Member State members of the Borderline and Classification Working Group (BCWG), a subgroup of the MDCG, through the Helsinki Procedure under the MDR and IVDR. It presents the background and outcome of cases on qualification (borderlines between medical devices or IVDs and medicinal products, biocides, cosmetics, personal protective equipment and other products) and on the application of classification rules. Software-related cases include a smartphone application for STI prevention strategies (information exchange between users and a behaviour-based risk calculator do not constitute a medical purpose, so it is not a medical device) and medical calculators (calculating scores such as CHA2DS2-VASc goes beyond simple search, so the product is a medical device, classified at least class IIa under Rule 11). Cases added in Version 5 include packaging for administering a medicinal product, a penis holster, a syringe containing glass beads, needles for root canal irrigation and saline solutions for nasal irrigation. The manual is to be read with MDCG 2019-11 (software qualification and classification), MDCG 2021-24, MDCG 2022-5 and other guidance. It is not legally binding, does not reflect the official position of the European Commission, and decisions on individual products remain with national competent authorities.
Published: 2026-04-22
NIST
IR
IR
IR 8259 Rev. 1
Foundational Cybersecurity Activities for IoT Product Manufacturers
Internet of Things (IoT) products often lack product cybersecurity capabilities their customers—organizations and individuals—can use to help mitigate their cybersecurity risks. Manufacturers can help their customers by improving the securability of their IoT products by providing necessary cybersecurity functionality and by providing customers with the cybersecurity-related information they need. This publication describes recommended activities related to cybersecurity that manufacturers should consider performing before their IoT products are sold to customers. These foundational cybersecurity activities can help manufacturers lessen the cybersecurity-related efforts needed by customers, which in turn can reduce the prevalence and severity of compromises.
Published: 2026-04-20
EU
MDCG
MDCG
Borderline Background Note
Background note on the use of the Manual on borderline and classification for medical devices under the Directives
Background note explaining that the manual on borderline and classification issued in May 2019 under the old medical device Directives (such as 93/42/EEC) remains available as a reference resource even after the new manual under the MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746) became operative in September 2022. It applies for as long as devices CE-marked under the old Directives remain on the market, and is maintained by the Borderline and Classification Working Group (BCWG) under the MDCG. It is non-binding guidance.
Published: 2026-04-01
EU
MDCG
MDCG
MDCG 2021-24 Rev.1
Guidance on classification of medical devices
Revision 1 of MDCG 2021-24 (guidance on classification of medical devices under the EU MDR), published 20 April 2026. It clarifies terminology by replacing the word "surgical" with "clinical" in the invasiveness definition, and updates the tables and practical notes for Classification Rules 2, 8, 9, 10, 12, 16 and 22. Based on the sources reviewed, the software classification rule (Rule 11) itself was not amended in this revision.
Published: 2026-04-01
FDA
CDRH
CDRH
fda_20260327_patient_preference_tplc
FDA Issues Final Guidance on Incorporating Voluntary Patient Preference Information Over the Total Product Life Cycle
FDA CDRH issued final guidance on the collection and submission of patient preference information (PPI). It includes recommendations on study design, validation, and the integration of PPI across the total product life cycle, and provides a roadmap for sponsors incorporating the patient perspective into regulatory submissions.
Published: 2026-03-27
MHLW
Notice
Notice
Admin-Notice-2026-03-25_SaMDQA3
Q&A Regarding Handling of Medical Device Software (Part 3) (Administrative Notice, March 25, 2026)
Q&A (Part 3) issued by the Japanese Ministry of Health, Labour and Welfare (MHLW), clarifying when manufacturing/marketing and sales activities are deemed to begin for home-use medical device software (SaMD) distributed via app stores or download servers. Manufacturing/marketing is deemed to start when the software is made available on a download server or app store, while sales is deemed to start when the end user is able to use it. Issued 25 March 2026 in response to a growing number of approved home-use device programs. It also confirms that a company acting as both marketing authorization holder and seller needs both business licenses (or notifications), and that legally required labeling information may be provided via easily accessible electronic records rather than a printed insert, provided it is given to the user before use.
Published: 2026-03-26
MHLW
Notice
Notice
Admin-Notice-2026-03-19_VPNSecurity
Notice on Strengthening Cybersecurity Measures for Network Devices such as VPN Equipment Connected to Medical Devices (Caution Alert) (Administrative Notice, March 19, 2026)
Caution alert (administrative notice, 19 March 2026) issued by the Japanese Ministry of Health, Labour and Welfare (MHLW) in response to a rise in ransomware attacks that exploit VPN equipment and other network devices connected to medical devices. It calls on marketing authorization holders to (1) confirm, under maintenance contracts with healthcare facilities, who is responsible for managing attached network equipment such as VPN devices, (2) check that firmware is up to date and identify any devices that are no longer supported, and (3) strengthen security by informing facilities about unsupported devices and applying stronger authentication and access control.
Published: 2026-03-25