Unlocking EU MDR Compliance through Gap Analysis and Risk Assessment for Medical Devices
The EU MDR Gap Analysis is a critical aspect of compliance with the European Union (EU) Medical Device Regulation (MDR). The new regulation, which came into effect in May 2020, replaces the Medical Device Directive (MDD) of 1993 and seeks to improve the safety and performance of medical devices, thus enhancing patient outcomes. The Gap Analysis between MDD and MDR is a systematic review of a medical device organization's quality management system (QMS) to identify any differences between the old MDD and the new MDR requirements. This analysis enables organizations to understand the impact of the EU MDR on their medical devices and assess any areas that need updating or improvement. Once the Gap Analysis is complete, it is crucial to perform a Risk Assessment Medical Device for each device in the organization's portfolio. The Risk Assessment Medical Device is a systematic evaluation of the potential harm that a medical device may cause to patients, users, or other individ...