AI/ML Good Machine Learning Practices
A new draft guidance was issued by Artificial Intelligence/Machine Learning-enabled Working Group, with comments welcomed until Friday…
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IMDRF Announces non-IVD MA ToC Updates
The International Medical Device Regulators Forum (IMDRF) have released several key updates and reorganization changes to the…
ARTG Exemptions for Certain Medical Devices
The Australian Therepeutic Good Administration (ARTG) has announced exemptions for certain medical devices …
FDA Final Ruling on LDTs (Laboratory Developed Tests)
T…
IMDRF Announces IVD MA ToC Updates
The In Vitro Diagnostic Medical Device Market Authorization Table of Contents (IVD MA ToC) has been updated from 2019 to…
Good Machine Learning Practices for Medical Devices
In 2021 Health Canada, the U.S Food and Drug Administration (FDA), and the United Kingdom’s Medicines and Healthcare products Regulatory…
MDCG 2022-13 Updated Guidance on Notified Bodies
The current guidance document regarding MDCG 2022-13 Rev. 1 Designation, Re-Assessment and Notification of Conformity Assessment Bodies and Notified Bodies…
New SCHEER Guidelines on Phthalates for Medical Devices
In 2019 the SCHEER (Scientific Committee on Health, Environmental and Emerging Risks) Guidelines on the benefit-risk assessment of the…
EU Regulatory Importer Requirements for Medical Device Software (MDSW)
While the MDCG has worked extensively on building up the library…
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