News

MHRA launches AI Airlock to address challenges for medical devices that use Artificial Intelligence

Last month, the MHRA outlined its strategy for regulating AI in response to a government white paper. This new pilot project aims to address challenge...

European Commission’s Dashboard about reprocessing of medical devices

The concept of "reprocessing" in the context of medical devices refers to the process of safely preparing a used device for reuse through cleaning, di...

New standards for biocompatibility, sterilization and processing have been harmonised

Recently CEN and Cenelec revised the harmonised standards and added sterilization, biocompatibility, and processing standards to the list. The standar...

New vigilance system guidelines for CE-marked medical devices MDCG 2024-1

In January 2024, a new MDCG 2024-1 Device Specific Vigilance Guidance (DSVG) Template was created to standardize the way medical incidents, serious in...

The US FDA published its final rule aligning U.S. quality regulations (QMSR) to international standards (ISO 13485)

The US FDA has released the awaited final decree on Quality Management System Regulation (QMSR), bringing its stipulations into alignment with the wid...