Saraca Solutions announced today that it has developed a tracking tool to reduce the time it takes to create an update for a clinical evaluation report (CER).
A CER documents conclusions for a medical device’s clinical evaluation. It consists of analyzed clinical data collected from either investigation of a company’s device or studies of substantially equivalent devices. Required for all medical devices marketed in Europe, the CER demonstrates that the device achieves its intended purposes without additional risk.
Saraca Solutions (New Delhi, India, and Fair Play, S.C.) developed an AI-based tool to automate some of the research and collection work, particularly for relevant article searches, which can reduce tasks that typically take nearly 15 hours down to about one hour.
“Our team’s deep experience in international medical device regulatory issues has led to creating these best practices for the benefit of our clients who depend upon us for this reporting compliance,” said company CEO Kuldeep Tyagi in a news release. “A number of companies we work with invested time and money into this process but turned to us to help complete them as they were challenged by interpretation of the standards.”
The new European Medical Device Regulation (EU MDR) originally required all medical devices to adopt the new standard this past May, but extended the deadline by one year due to the COVID-19 pandemic. Tyagi noted that many companies held back in their efforts to comply with this regulation because of the possibility the deadline would change.
“Everybody waited for the last minute,” he said. “Developing or revising a CER can be complex and the regulations don’t necessarily provide a clear path to its final structure while the resulting report or data, analysis and conclusions for device safety need to be understood by the notified body.”
