Second Edition of Definition of MDA Medical Device Guidance Published
December 18th, 2025 the Medical Device Authority (MDA) released for consultation the Second Edition of the Definition of Medical Device Guidance Document (MDA/GD/0006). This document provides critical clarifications on the definitions of medical devices, accessories, components, and spare parts under the Medical Device Act 2012 (Act 737).The feedback period runs from 4 December 2025 to […]
Draft EU Implementing Act on Notified Body Procedure Published
Europe, 18 December 2025 — the European Commission took a significant step toward stabilizing the European medical device market by releasing a Draft EU Implementing Act on the Notified Body Procedure. This new draft act lays down uniform quality management and procedural requirements for conformity assessment activities carried out by Notified Bodies designated under Regulation […]
MHRA PUBLISHES IN VITRO DIAGNOSTIC (IVD) ROADMAP
UK, 18 December 2025 — IVD, Medical Devices The Medicines and Healthcare products Regulatory Agency (MHRA) has officially published its In vitro diagnostic (IVD) roadmap. Released on 15 December 2025, this “living document” outlines the strategic deliverables for the regulation of diagnostic devices over the next two years (2026–2027).This roadmap is a key component of […]