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...
Europe – EU device expert warns manufacturers not to wait until the last minute...
AN EU medical device expert advised manufacturers to avoid submitting applications at the last minute for approval under the Medical Devices Regulation (MDR) and the In Vitro...
Europe – Clinical strategy as part of pre-submission dialogue between manufacturer and Notified Body
MedTech Europe, AESGP, MedTech &Pharma Platform and COCIR would like to express their concern that the recently updated MDCG 2019-6: Requirements relating to notified...
Europe – Urgent call for clarity on clinical strategy discussions
MedTech Europe, AESGP, MedTech & Pharma Platform and COCIR would like to express their concerns that the recently updated MDCG 2019-6: Requirements relating to notified bodies...
