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...
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...
Europe – Risk Categorization Per the European AI Act
Article 6 of the AI Act defines the criteria for an AI system to be classified as high-risk. According to paragraph 1(b), an AI...
Europe – Pilot on the Advice from the Expert Panels to Manufacturers of HighRisk...
Regulation (EU) 2017/745 on medical devices (Medical Devices Regulation, MDR) Article 106 and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (In Vitro...
Europe – EMA qualifies first artificial intelligence tool to diagnose inflammatory liver disease (MASH)...
EMA’s human medicines committee (CHMP) has issued the first Qualification Opinion (QO) on an innovative development methodology based on artificial intelligence (AI). The tool,...
Europe – Update – MDCG 2020-16 rev.4 – Guidance on Classification Rules for in...
This guidance, relating to the application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) addresses the classification of in vitro diagnostic...
