Use of Retrospective RWD for MDR Compliance
As EU MDR has already entered into force and will be applicable in May 2020, the device companies are getting geared up to be MDR compliant. EU MDR enforces stringent requirements related to clinical evidence and post marketing obligations on device companies in proportion with risk class and the type of device. The device companies are exploring different approaches, considering both reactive and proactive, to develop a system to collect real world data and use it appropriately for generating clinical evidence and at the same time to be EU MDR compliant. This white paper focuses on retrospective data that device companies can use cost effectively to support clinical evidence, update risk-benefit determination and fulfill PMS requirements as per EU-MDR.