TGA UDI Requirements for Medical Devices Commence in Australia
From 1 July 2026, certain medical devices supplied in Australia must meet TGA Unique Device Identification requirements, starting with Class IIb and Class III devices.
FDA CBER Updates SOPP on MDUFA User Fee Payments and Billing Activities
FDA CBER has updated SOPP 8704 on MDUFA user fee payments and billing activities, including electronic payments, payment verification, user fee holds, refunds and establishment registration fees.
NBCG-MED Publishes Operational Elements for Hybrid Audits under MDR and IVDR
NBCG-MED has published operational elements for the application of hybrid audits to QMS assessments under the MDR and IVDR, including on-site requirements, ICT use and audit planning.
European Commission Drafts Updated Common Specifications for Certain Class D IVDs
The European Commission has published a draft implementing regulation amending common specifications for certain Class D IVDs under the IVDR, including HEV, Toxoplasma gondii, Plasmodium and arboviruses.
Swissmedic Updates Information Sheet on IVD Performance Studies
Swissmedic has updated its information sheet on IVD performance studies, covering approval procedures, reporting duties, ISO 20916, category C studies and Swissmedic surveillance.
MDCG Updates Guidance on Standardisation for Medical Devices
The MDCG has updated its guidance on standardisation for medical devices, covering harmonised standards, presumption of conformity, state of the art, common specifications and EU case law.
MHRA Updates Guidance on Clinical Investigations for Medical Devices
The MHRA has updated its guidance on clinical investigations for medical devices, including applications, assessment timelines, amendments, reporting requirements and fee waiver information.
CD-P-TO Calls for Clarification on MDR Implications for the SoHO Sector
The CD-P-TO has published a position paper on the MDR and its implications for the substances of human origin sector, focusing on Article 5(5), RUO products and CE-marked devices used beyond their intended purpose.
Swissmedic Updates swissdamed User Guide for the UDI Devices Module
Swissmedic has updated its swissdamed User Guide for the UDI Devices Module, including guidance on UDI registration, market status, M2M, Master UDI-DI and legacy devices.
European Commission Publishes 20th Notified Body Survey Results under MDR and IVDR
The European Commission has published the 20th Notified Body survey results under the MDR and IVDR, with data status 28 February 2026.
FDA Updates Guidance on Submitting Next-Generation Sequencing Data to the Division of Antivirals
FDA has updated its technical specifications guidance on submitting next-generation sequencing protocols, data and analyses to the Division of Antivirals.
NIST Highlights Need for Continuous Security Monitoring of AI Systems
NIST has published a news release on a mathematical proof supporting the transition from a “one and done” AI security model to continuous monitoring and updating.
European Commission Publishes Third Survey Results on Medical Device Availability in the EU
The European Commission has published the third EO survey results on the availability of medical devices and IVDs on the EU market, with data status 31 October 2025.
Team-NB Proposes Risk-Adaptive Surveillance System under the MDR
Team-NB has published a proposal for a risk-adaptive surveillance system under the MDR, covering surveillance audits, unannounced audits, technical documentation sampling and PSUR updates.
TGA Updates Guidance for Dental Practitioners on Personalised Medical Devices
The TGA has updated its guidance on regulatory requirements for Ahpra-registered dental practitioners making or adapting personalised medical devices for patients.
FDA Announces Upcoming eMDR System Enhancements
The FDA has announced upcoming eMDR system enhancements, including AEMS consolidation, country code requirements and IMDRF adverse event code updates.
MHRA Outlines Data Requirements to Support Regulatory Decision-Making
The MHRA has published a paper on regulatory-grade data, real-world data and the data infrastructure needed to support safety surveillance and regulatory decision-making.
Team-NB Proposes Risk-Adaptive Surveillance System under the IVDR
Team-NB has published a proposal for a risk-adaptive surveillance system under the IVDR, covering surveillance audits, unannounced audits and technical documentation sampling.
TGA Updates Guidance on Medical Device Application Audit Selection Criteria
The TGA has updated its guidance on how medical device and IVD applications are selected for audit before inclusion in the ARTG.
Anvisa Publishes Technical Documentation for Integration of Electronic Prescription Systems with the SNCR
Anvisa has published technical documentation supporting the integration of electronic prescription systems with the SNCR, including API specifications, technical requirements and developer guidance.