Health Technology Assessment - Commission adopts rules for joint scientific consultations on medical devices and in vitro diagnostic medical devices Today, the European Commission adopted an implementing regulation establishing the rules for joint scientific consultations on medical devices and in vitro diagnostic medical devices, under the Health Technology Assessment (HTA) Regulation. The implementing act provides detailed procedural rules for the…
Ben KempFebruary 3, 2025
Health Canada have issued guidance regarding Biotin interference with Immunoassays. Learn more here.
Ben KempJanuary 17, 2025
Amendments have been made to the Food and Drug Regulations and Medical Devices Regulations that advance Health Canada’s modernization agenda by making Canada’s science-based regulatory system more agile and internationally aligned. Find out more here.
Ben KempJanuary 16, 2025
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