A2.3 Managing clinical data under the Medical Device Regulation (MDR)

This presentation is part of a full breakout session. To add this presentation to your schedule you must add the full breakout session.

Navigating the regulatory landscape of bringing medical devices to the market and keeping them there is a challenge. The Medical Device Regulation (MDR) has brought significant changes to the medical device industry in the EU since coming into effect in May 2021. New challenges include increased scrutiny of device safety and performance and stricter rules for post-market surveillance. 

Small to medium sized manufacturers with limited resources can struggle in particular to adapt to these changes, as they may lack the expertise or infrastructure needed to comply with the new regulations. As a result, many manufacturers are at risk of falling behind their larger competitors and may struggle to bring their products to market or to recertify. Clinical data management is an essential part in a regulatory strategy as it comprises the backbone of efficient data collection and timely reporting. 

This presentation will showcase key learnings from a medium sized medical device company with a portfolio of class-III active implantable medical devices, which are considered the highest risk device class. We will discuss challenges of clinical data management and the types of clinical data that are routinely collected, including best practices for regulatory compliance and risk mitigation in clinical data management. We will also discuss the role of technology in streamlining clinical data management and ensuring compliance with the MDR.