Technical Documentation Structure Under MDR
INTRODUCTION SMART START TO EU MDR TECHNICAL DOCUMENTATION EU MDR technical documentation is basically two folders you must maintain for almost every device (except custom-made): (1) the Technical Documentation for pre-market assessment (Annex II) and (2) the Post-Market Surveillance (PMS) documentation (Annex III). Think of Annex II as “how we designed it and proved it’s […]
ISO/DIS 18969 Sets Out a Global Framework for Clinical Evaluation of Medical Devices
ISO — A new ISO draft standard proposes a common, life-cycle-wide method for showing device safety, performance, and benefit-risk using human clinical data signaling tighter, more consistent expectations for clinical evidence worldwide. Claims to evidence with CEP/CER gap-assessment INTRODUCTION ISO has released ISO/DIS 18969, a Draft International Standard that defines terminology, principles, and a process […]
CDSCO Medical Device Procurement: New Expectations for Indian Medical Device Licensing
CDSCO — The Central Drugs Standard Control Organization (CDSCO) has issued a new circular on 17 November 2025 that fundamentally reshapes how hospitals and public agencies procure medical devices in India. The message from the Drugs Controller General of India (DCGI) is unambiguous: Indian licenses under the Medical Devices Rules (MDR) 2017 are now the […]