ISO 13485:2016 Confirmed - No Revision for Now! ISO 13485:2016 has officially been confirmed for another five years, meaning it will remain unchanged until the next systematic review. The current focus now shifts to the revision of the ISO 13485 Handbook, which will...

MDR & Medical Device Coordination Group (MDCG) guidance: PMCF and Risk The MDR does foresee a risk-based approach to PMCF. Per Preamble (33), the clinical evaluation process is closely interlinked with risk management, which aims to mitigate any residual clinical...

01 October 2025 EMA/INS/GMP/369445/2024 EMA Inspections Office From now on, EU and FDA regulators can rely on each other’s GMP inspections not only within their territories but also outside the EU and US; a huge leap towards global inspection efficiency and reduced...

Mandatory requirements for additional product information  for medical devices (MDs) and in vitro diagnostic medical devices (IVDs) have exponentially increased recently. Under the current legislative system in the EU, both essential information (information needed...