On 14 April 2025, Team-NB – the European Association of Medical Devices Notified Bodies – published three position papers addressing different crucial aspects of medical…
Future UK medical devices regulation: Roadmap
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released Version 2.0 of its Medical Devices Regulatory Reform Roadmap, providing a detailed timeline for…
Regulatory requirements for AI medical devices
In June 2023, the European Parliament adopted its position on the Artificial Intelligence Act (AI Act). Lawmakers have already started their negotiations to define the…