The EU IVDR Countdown: Mastering PMS Data Collection and Reporting for Compliance

As IVD manufacturers embark on the EU IVDR transition journey, it is critical to begin developing strategies for effective post-market surveillance (PMS) data collection and reporting, as PMS reports are now mandatory for surveillance audits. 

However, data collection, processing, and evaluation from multiple sources can be time-consuming, and the shortage of skilled resources further aggravates the situation. In light of this, manufacturers should develop smart and efficient solutions to overcome these challenges to maintain the certification status of their devices.