Australia – Understanding regulatory requirements for in vitro diagnostic (IVD) companion diagnostics (CDx)
The purpose of this guidance is to outline the regulatory framework for in vitro diagnostic (IVD) companion diagnostics (CDx) and for the medicine or...
Europe – MIR PDF 7.3.1 New MIR form – mandatory as from November 2025
The Manufacturer Incident Report (MIR) Form v7.3.1 is the official European Union template used for reporting serious incidents involving medical devices under the MDR/IVDR...
International – ISO 10993-23: 2021/Amd.1:2025 – Biological evaluation of medical devices — Part 23:...
Traditionally, tests in small animals have been performed prior to testing on humans to help predict human responses. More recently, in vitro tests as...
UK – Nice recommends first AI medical device for skin cancer diagnosis in the...
NICE has endorsed DERM, an autonomous AI medical device developed by Skin Analytics, for detecting skin cancer. This recognition marks a major step in...
Europe – EUDAMED user guide : UDI Devices
Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro
diagnostic medical devices introduce an EU identification system for medical devices
based on...
Europe – European Artificial Intelligence Act (Version 2)
This position paper provides an overview of the Team-NB perspective on the challenges of the AI Act with particular attention to its implementation.
Because of the...
Europe – Best Practice Guidance for the Submission of Technical Documentation under Annex II...
General Considerations
The most common reasons for delays in Technical Documentation assessments by notified bodies are:
• Incomplete Submissions – Insufficient or missing information not provided...
UK – Clinical investigations of medical devices – guidance for manufacturers
It is important to note that the rules for notifying the MHRA of a clinical investigation in
Great Britain (England, Wales and Scotland) differ from...
International – ISO 15223-1:2021/Amd 1:2025 Medical devices — Symbols to be used with information...
A revised EC REP symbol, no longer tied to a specific country or region, supporting broader international use and simplifying labeling for manufacturers operating...
International – Medical Devices: Post Market Surveillance National Competent Authority Report Exchange Criteria and...
The NCAR Exchange Program will be used to exchange information relating to significant concerns or potential trends that individual authorities have observed in their...
