Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure

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...
TEAM-NB : Survey on NBs applications against IVD new regulation

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...
TEAM-NB : Survey on NBs applications against IVD new regulation

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...

NOS PROCHAINES FORMATIONS