The European Commission has launched a survey on Electronic Instructions for Use for medical devices, seeking feedback from healthcare professionals and healthcare institutions in the EU.

MDCG 2020-16 rev.5 updates guidance on classification rules for in vitro diagnostic medical devices under Regulation (EU) 2017/746, with clarification of Rule 7 and revised examples.

Swissmedic, SULM and FAMH have developed the Swiss Good Practice for Materiovigilance in In-Vitro Diagnostics, supporting laboratories, hospitals and POCT settings in identifying, assessing and reporting serious IVD incidents and implementing FSCA/FSN measures.

The FDA’s sDHT medical device list identifies sensor-based digital health technology medical devices authorized for marketing in the United States, supporting transparency for innovators, healthcare providers and patients.

The FDA provides an overview of augmented reality and virtual reality in medical devices, including definitions, clinical applications, benefits, risks and a list of AR/VR medical devices authorized for marketing in the United States.

The FDA has updated MQSA national statistics, including certified mammography facilities, accredited units, DBT units, FY 2026 inspection outcomes and reported annual mammography procedures.

The FDA’s AI-Enabled Medical Devices List identifies AI-enabled medical devices authorized for marketing in the United States and provides transparency for innovators, healthcare providers and patients.

The TGA has amended the Clinical Decision Support System exemption to clarify when it applies, with amendments taking effect from 1 November 2026 and no change to the exemption scope or new regulatory requirements.

The TGA has introduced a new classification rule for certain non-invasive saline-only medical devices used to maintain patency or flush the lumen of another medical device, classifying them as Class IIa under Clause 2.2.

Swissmedic has updated its technical interpretation on market release and distribution in cooperation with a pre-wholesaler, clarifying MAH responsibilities, quality agreements, outsourced activities, traceability, audits, retention samples and GDP compliance.

The Swiss Federal Council has announced measures to extend IVD transition periods, continue simplified labelling requirements for certain IVDs and introduce medical device and IVD product registration in swissdamed from 2026.

The European Commission Joint Research Centre has published a study on cyber security in the health and medicine sector, analysing evidence of patient health consequences resulting from cyber incidents in healthcare settings.

FDA’s draft guidance on Drug Master Files explains DMF types, submission format, original and subsequent submissions, letters of authorization, annual reports, FDA review policies and DMF closure.

The TGA has published version 3.0 of its overview of Unique Device Identification for Australian healthcare, explaining UDI concepts, AusUDID, phased implementation, healthcare adoption, reporting and device-specific requirements.

The MHRA-NICE Real-World Evidence Scientific Dialogue has been updated to include applications relating to RWE and medical devices, with Approved Bodies represented in relevant workshops.

Health Canada has updated forms FRM-0577 and FRM-0578 for exceptional importation and sale of foreign-authorized medical devices, including new web forms, supporting documentation fields and a shorter shipment notification timeframe.

Swissmedic has updated the swissdamed Business Rules technical document to version 5.0, covering UDI-DI registration, legacy devices, Master UDI-DI, certificate rules, device data exchange and SRN format requirements.

MDSAP has updated its Special Remote Assessment Procedure, describing how remote assessments of auditing organizations are planned, performed, documented and reviewed within the Medical Device Single Audit Program.

Swissmedic has updated its information sheet on notification of quality defects for medicinal products and active pharmaceutical ingredients, including reporting obligations, timelines, contact points, measures and fees.

FDA has issued final guidance on premarket notification 510(k) submissions for dental curing lights, covering device description, predicate comparison, labeling, reprocessing, biocompatibility, software, cybersecurity, electrical safety, wireless technology and non-clinical performance testing.