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
Health Canada have updated/published their Guidance for determining medical device application type: This document provides guidance to medical device manufacturers on the different application types listed in the Medical Devices Regulations, including how to determine when medical devices can be combined and submitted as one application. View article...
Ben KempSeptember 8, 2025
Self-sampling at the point-of-care – enhancing access, improving care As the UK regulator for medical devices, the MHRA ensures that self-sampling devices are safe, effective, and properly registered before they can be used. This article, which the MHRA have co-authored with the Royal College of Pathologists, sets out clear guidance on regulation, including device marking (UKCA/CE), transport requirements, and the…
Ben KempSeptember 8, 2025
We are resharing this update from earlier in the year: TGA - Use of market authorisation evidence from comparable overseas regulatory and assessment bodies for medical devices (including IVDs) Use of market authorisation evidence from comparable overseas regulators and assessment bodies for medical devices (including IVDs) | Therapeutic Goods Administration (TGA) Mentions CE to the directives and the regulation for…
Ben KempAugust 28, 2025
Dear members, please be advised that the following standard regarding full material declarations has been published. Derived from the existing IEC standard BS EN IEC 62474:2019+A1:2021 | 31 Jan 2021 | BSI Knowledge for full material declarations for products of and for the electrotechnical industry. BS EN IEC 82474-1:2025 | 31 Jul 2025 | BSI Knowledge The standard provides a…
Ben KempAugust 28, 2025
Dear members, CENELEC have adopted EN IEC 61326-2-6:2025 Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical electrical equipment (publication date=2025-08-22) as a European standard. This has not been harmonised to the IVDR at this time. View article... Adoption as a British Standard is currently proceeding British…
Ben KempAugust 28, 2025