New Team-NB Update on Companion Diagnostics Under the IVDR
Team-NB has released a guidance paper on Companion Diagnostics (CDx), providing clarity on how to interpret significant changes to CDx…
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New UK CE Certificate Rules for ARTG Inclusion Applications
The TGA has released the Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Amendment Determination 2025, introducing new provisions regarding…
EU Decision 2025/2078: Harmonized Medical Standards Update
The European Commission published Implementing Decision (EU) 2025/2078, amending Implementing Decision (EU) 2021/1182 by adding the following harmonized standards referenced…
New MHRA Guidance on Device Registration Fees
Following its earlier announcement of the forthcoming annual device registration fee (effective 1 April 2026), the Medicines and Healthcare products…
MHRA’s New Fee Structure: What It Means for Manufacturers
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced significant changes to its statutory…
Manual on Borderline and Classification Under the IVDR and MDR
The Borderline and Classification Working Group (BCWG) has released Version 4 (September 2025) of the Manual…
MHRA Designated Standards Survey Newly Launched
On September 5th, the UK Medicines and Healthcare products Regulatory Agency (MHRA) launched a designated standards survey to identify which…
Updated TGA Essential Principles Checklist
The Therapeutic Goods Administration (TGA) has released an updated version of the Essential Principles (EP) checklist for medical devices and…
EU Launches Evidence on Targeted Revision of MDR and IVDR
The European Commission has launched a Call for Evidence on the planned targeted revision of the Medical Device Regulation (MDR,…
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