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.
European Commission Publishes Consolidated Version of the AI Act Incorporating Digital Omnibus Amendments
The European Commission has published an unofficial consolidated version of the AI Act incorporating the Digital Omnibus amendments, providing an updated reference for manufacturers and other stakeholders.
MHRA Updates Guidance on Borderlines with Medical Devices and Other Products in Great Britain
MHRA guidance on medical device borderlines in Great Britain, covering intended purpose, UKCA scope and manufacturer considerations.
Anvisa to Discontinue Sicert Medical Device Certificate Issuance System
Anvisa has announced the permanent discontinuation of the Sicert Medical Device Certificate Issuance System, completing the transition to the new certificate generation tool integrated into the Solicita System.
NIST Publishes Initial Public Draft for Revision of IoT Product Cybersecurity Guidelines for the US Federal
NIST has published the Initial Public Draft of SP 800-213r1, updating IoT product cybersecurity guidelines for the US Federal Government and introducing a product-focused approach with direct implications for medical device and IVD manufacturers.
MDCG Publishes Guidance on Clinical Evaluation for Orphan Medical Devices
The MDCG has published MDCG 2024-10, providing guidance on the clinical evaluation of orphan medical devices, including recommendations on clinical evidence generation, study design, post-market clinical follow-up and benefit-risk assessment under the MDR.
MHRA Updates Guidance on Medical Device Registration in Great Britain
The MHRA has updated its guidance on registering medical devices in Great Britain, clarifying registration requirements, UK Responsible Person obligations, documentation expectations and procedures for managing registered devices.
Team-NB Publishes Position Paper on Supporting Micro and Small Medical Device Manufacturers
Team-NB has published a position paper proposing measures to support micro and small medical device manufacturers under the MDR and IVDR, focusing on regulatory efficiency, structured dialogue, risk-based oversight and regulatory capability.
ANVISA Launches Public Consultation to Review the Regulatory Framework for Medical Device Vigilance
ANVISA has launched a public call for contributions to support the revision of Brazil's medical device vigilance regulatory framework, seeking feedback from medical device registration holders on post-market surveillance requirements and future regulatory developments.
TGA Introduces Australia's UDI System with Phased Implementation Through 2029
The TGA has introduced Australia's Unique Device Identification (UDI) system with a phased implementation through 2029. Learn about the implementation timeline, AusUDID requirements, and what medical device and IVD manufacturers need to prepare.
FDA Classifies Endoscopic Traction Devices as Class II Medical Devices
FDA classifies the Endoscopic Traction Device as a Class II medical device with Special Controls, setting performance, safety, and labeling requirements applicable to medical device and IVD manufacturers.
MDCG publishes guidance on the transition from the ‘EC REP’ to the ‘EU REP’ symbol
The MDCG has published an appendix to MDCG 2021-5 clarifying the transition from the 'EC REP' to the 'EU REP'symbol under EN ISO 15223-1, including a five-year transition period for medical device and IVD manufacturers.
Swissmedic publishes updated swissdamed Playground User Guide
Swissmedic has published Version 3.0 of the swissdamed User Guide – Playground, providing updated instructions for testing actor registration and UDI management before using the production environment.
European Parliament briefing highlights implementation of the EU Artificial Intelligence Act
A new European Parliament briefing provides an overview of the EU Artificial Intelligence Act, including its risk-based framework, implementation timeline, and key provisions relevant to AI systems, including those used in medical devices.
FDA Classifies Ingestible Gastrointestinal Blood Detection Capsule as a Class II Medical Device
The FDA has classified the ingestible gastrointestinal blood detection capsule as a Class II medical device, establishing special controls to support the safety and effectiveness of this innovative diagnostic technology.