Aug 25, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published a guidance document that addresses the information accompanying (active) implantable medical devices, including patient information...
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May 13, 2021
EU MDR/IVDR
The European Commission (EC), the European authority in the sphere of medical devices, has proposed a new framework for the use of Artificial Intelligence technology in medical devices. The document is intended to introduce harmonized rules for AI-based medical...
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Apr 27, 2021
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission, the EU regulating authority in the sphere of medical devices, has published updated guidance on standardization. Due to its legal nature, the document should neither be treated...
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Sep 25, 2019
North America
The FDA, the regulating authority in the sphere of medical device circulation of the United States, issued guidance providing additional information on new pilot conformity assessment procedures. ASCA: key points The Accreditation Scheme for Conformity Assessment...
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Sep 16, 2019
North America
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released four final guidances in an effort to improve the efficiency of its 510(k) marketing authorization pathway. Special 510(k) Program Abbreviated 510(k) Program Format...
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