The European AI Act: Requirements for High-Risk AI Systems
Emergo by UL has been reporting on the landmark legislation that is the Artificial Intelligence Act (AIA). As the AIA was given the green light by EU institutions and the finish line is in sight, it seems fitting to conclude our regulatory series with a brief recap, as well as a focus on the high-risk AI systems on which the regulation is mainly concerned.
Legislation Published to Delay Compliance for Legacy IVDs and EUDAMED Rollout
Additional legislation officially amending the Medical Devices Regulation (2017/745, MDR) and In Vitro Diagnostic Devices Regulation (2017/745, IVDR) was published as Regulation 2024/1860 on June 13.
Second Quarter 2024: Global Medical Device Regulatory Harmonization Continues
In this update, we take a whirlwind tour of countries exemplifying regulatory reliance, IVD updates and global harmonization modeling.
M&A Regulatory Due Diligence Services for Medical Devices
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IMDRF Updates Guidance on Global Regulatory Submissions
Global harmonization of medical device registration submissions is one way to advance the objectives of the International Medical Device Regulators Forum (IMDRF) and regulatory reliance. These documents are a must-read for any serious regulatory professional. For medical device manufacturers, here we elaborate on our regulatory update from April 2023.
US FDA, Health Canada and UK MHRA Update on Transparency Guiding Principles for Machine Learning-Enabled Medical Devices
The US Food and Drug Administration (FDA), Health Canada and UK MHRA (June 13) built on their 2021 guiding principles for good machine learning practice for medical device development by further identifying guiding principles for transparency for machine learning-enabled medical devices (MLMDs).
New Zealand to Repeal Therapeutic Products Act 2023
The New Zealand Associate Minister of Health announced the government’s intent to repeal the Therapeutic Products Act 2023, which otherwise would come into force this year.
Updated European Commission Data Dashboard
The EC has updated the medical device availability dashboard announced in early 2024.
Mexico’s Ministry of Health Makes Progress with SaMD
The regulator in Mexico, COFEPRIS, released a 5.0 edition of the Supplement of Medical Devices of the Mexican Pharmacopoeia (hereafter: Pharmacopoeia), which inserted regulatory requirements for Software as a Medical Device (SaMD).
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