MedTech Europe Calls Against Reusability by Default Under MDR Article 17
MedTech Europe has published a position paper arguing that reusability should not become the regulatory default for single-use medical devices under MDR Article 17, while supporting safe, evidence-based reprocessing.
UK Health Bill Proposes New Medical Device Licensing Regime for Great Britain
The UK Health Bill 2026 proposes new powers to establish a medical device licensing regime for Great Britain, enabling MHRA to directly assess and license devices through future secondary legislation.
European Commission Launches Survey on eIFUs for Professional Use Medical Devices
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 Updates Guidance on IVDR Classification Rules for IVDs
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 Publishes Swiss Good Practice for IVD Materiovigilance
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.
FDA Highlights Medical Devices Incorporating Sensor-Based Digital Health Technology
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.
FDA Highlights Augmented Reality and Virtual Reality in Medical Devices
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.
FDA Updates MQSA National Statistics for Mammography Facilities and Inspections
The FDA has updated MQSA national statistics, including certified mammography facilities, accredited units, DBT units, FY 2026 inspection outcomes and reported annual mammography procedures.
FDA AI-Enabled Medical Devices List Reaches 1,614 Entries
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.
TGA Amends Clinical Decision Support System Exemption
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.
TGA Updates Classification Rules for Certain Combination Products
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 Updates Technical Interpretation on Market Release and Pre-Wholesaler Distribution
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.
Swiss Federal Council Announces Measures on IVD Supply and Medical Device Transparency
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.
European Commission JRC Report Examines Health Consequences of Cyber Incidents in Healthcare
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 Draft Guidance Explains Drug Master File Submission and Review Expectations
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.
TGA Publishes Updated Overview of UDI for Australian Healthcare
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.
MHRA-NICE Real-World Evidence Scientific Dialogue Now Accepts Medical Device Applications
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 Updates Forms for Exceptional Importation and Sale of Medical Devices
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 Updates swissdamed Business Rules to Version 5.0
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 Updates Special Remote Assessment Procedure
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.