Health Canada’s IMDRF ToC Guidance: What Medical‑Device Manufacturers Must Know (2025)
Health Canada has recently formalized the use of the IMDRF‑aligned Table of Contents (ToC) format for medical device submissions. This shift marks a major step towards global harmonization of regulatory submissions and directly affects how device manufacturers prepare pre‑market and post‑market documentation. The new guidance impacts submissions for Class II, III, and IV devices both […]
MHRA Updates Clinical Investigation Guidance : What Manufacturers Need to Know
The MHRA’s “Clinical investigations for medical devices” guidance acts as the official framework for when and how medical device manufacturers must notify and obtain approval for clinical investigations in the UK (Great Britain and Northern Ireland). Given evolving regulatory landscapes including post‑Brexit UK regulations (UK Medical Devices Regulations 2002 (UK MDR 2002)) and continued alignment with […]
General Safety and Performance Requirements (GSPR) under EU MDR 2017/745
GSPR MADE EASY: YOUR NO-STRESS GUIDE TO EU MDR SAFETY RULES The EU MDR requires all medical device manufacturers to show that their devices are safe, perform as intended, and remain reliable throughout their lifecycle. This is done by meeting the General Safety and Performance Requirements (GSPR) listed in Annex I of the Regulation. Article […]