TGA Issues Comprehensive Guidance on Essential Principles for Medical Devices
Australia, November 24, 2025 — The Therapeutic Goods Administration (TGA) has released an updated guidance document titled “Complying with the Essential Principles on the Safety and Performance of Medical Devices,” offering a thorough breakdown of the mandatory requirements for medical device manufacturers supplying products in Australia. This guidance aligns with the Essential Principles outlined in […]
Clinical evaluation under the EU MDR
YOUR EASY START TO CLINICAL EVALUATION UNDER EU MDR Clinical evaluation under the EU MDR basically means proving that your medical device is safe, works as intended, and provides more benefit than risk. The law (Article 61 and Annex XIV) requires every manufacturer to continuously assess clinical evidence for their device not just before CE […]