Standard for conducting LCAs for Electrical and Electronic Equipment. Not sure if there is work ongoing separately for a MD or IVD LCA. EN IEC 63366:2025 - Product category rules for life cycle assessment of electrical and electronic products and systems (publication date=2025-08-01) View article...
Ben KempSeptember 8, 2025
FDA has issued Guidance on the use of Predetermined Change control plans for AI enabled device software functions.
Ben KempSeptember 8, 2025
Please find here second edition of the IMDRF 2025 Implementation report. This provides an overview of the degree to which IMDRF Guidance etc. has been applied to the regulatory frameworks of the IMDRF member countries.
Ben KempSeptember 8, 2025
New EU active substance approval decision Apply for product authorisation to access the NI market. Following evaluation under the EU Biocidal Products Regulation (EU BPR), a decision has been taken to approve the following active substance/product type combination. This will affect NI: 1 August 2025 2-methyl-2,3-dihydro-1,2-thiazol-3-one hydrochloride (CAS 26172-54-3 EC 247-499-3) in product type 6 Action for biocidal product suppliers…
Ben KempSeptember 8, 2025
You can find the latest information here: https://www.sahpra.org.za/wp-content/uploads/2025/08/COMM-Issue-No.-MD07_2025_26-v2-2.pdf
Ben KempSeptember 8, 2025
You can find the latest information here: https://www.tga.gov.au/resources/guidance/reporting-medical-device-adverse-events-healthcare-facilities
Ben KempSeptember 8, 2025
You can find the Australian Government's release here: https://www.tga.gov.au/resources/guidance/understanding-regulation-software-based-medical-devices
Ben KempSeptember 8, 2025