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.
FDA Classifies Radiological Machine Learning-Based Quantitative Imaging Software with Predetermined Change Control Plans as Class II Devices
The FDA has classified radiological machine learning-based quantitative imaging software with predetermined change control plans as Class II medical devices, establishing special controls to support the safe development and regulatory oversight of AI-enabled imaging software.
Swissmedic Publishes Version 2.0 of the swissdamed UDI Data Dictionary
Swissmedic has published Version 2.0 of the swissdamed UDI Data Dictionary, introducing new data elements and clarifying requirements for the registration and management of UDI information for medical devices in Switzerland.
Swissmedic Publishes Guidance on the Procurement of Medical Devices in Healthcare Institutions
Swissmedic has published Version 6.0 of its Information Sheet – Procurement of Medical Devices in Healthcare Institutions, providing guidance on the procurement of medical devices and IVDs in Switzerland, including conformity documentation, certificate verification and the use of swissdamed.
Swissmedic Publishes User Guide for the swissdamed UDI Devices Module
Swissmedic has published Version 3.0 of the swissdamed User Guide – UDI Devices Module, introducing new functionalities for device registration and management, including Machine-to-Machine (M2M) processes, manual UDI-DI management and Master UDI-DI requirements.
MDCG Publishes Position Paper on the Management of SS(C)Ps in EUDAMED After Mandatory Use
The MDCG has published MDCG 2026-4, providing clarification on the management of Summary of Safety and Clinical Performance (SSCP) and Summary of Safety and Performance (SSP) documents in EUDAMED following the mandatory use of the platform’s first modules.
MedTech Europe Supports MDR and IVDR Simplification Proposal Focused on More Proportionate Lifecycle Oversight
MedTech Europe has published its position on the European Commission’s proposal to simplify the MDR and IVDR, supporting a more proportionate and risk-based approach to oversight, surveillance and assessment activities throughout the lifecycle of medical devices.
Swissmedic Updates Formal Requirements Guidance for Medicinal Product Authorisation Applications
Swissmedic has published Version 21.0 of its Formal Requirements guidance document, introducing updates and clarifications relating to medicinal product authorisation applications, documentation requirements, biosimilars, Article 13 TPA submissions and combination products incorporating medical devices.
FDA Publishes Draft Guidance on Forms FDA 3542a and FDA 3542 for Orange Book Patent Submissions
FDA has published draft guidance on Forms FDA 3542a and FDA 3542, clarifying requirements for Orange Book patent listings, electronic patent submissions, and the management of patent information throughout the medicinal product lifecycle.