The BioMed Alliance has released two policy documents which include recommendations from healthcare professionals to address persisting challenges in the implementation of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). While these regulations aim to enhance the safety and transparency of medical devices and diagnostics across Europe, they believe there are certain shortcomings that must be…
Ben KempJanuary 14, 2025
Current status: Open Opened on December 28, 2024 and will close on March 8, 2025. Health Canada is proposing to amend the Food and Drug Regulations and Medical Devices Regulations to help prevent and mitigate the risk of harm to human health due to drug and medical device shortages and discontinuations. The proposed amendments: are outlined in the Regulations Amending…
Ben KempJanuary 8, 2025
You can find ISO/TS 16766:2024Manufacturers’ considerations for in vitro diagnostic medical devices in a public health emergency here.
Ben KempDecember 18, 2024
Health Canada have issued updated guidance for medical device recalls - Overview: Guide for recalling medical devices (GUI-0054) - Canada.ca
Ben KempDecember 18, 2024
TGA Australia have update the ARTG webpage - Australian Regulatory Guidelines for Medical Devices (ARGMD) | Therapeutic Goods Administration (TGA)
Ben KempDecember 18, 2024