This session will focus on our EU MDR certification journey from preparation, submission, review, audit to certification for Class IIb and Class III active implantable devices. It will cover the challenges with legacy devices to be reviewed as a brand new submission under Medical Device Regulations. We have experience with two different notified bodies so we will present the compare and contrast in this presentation. We will also present the challenges beyond certification, i.e., negotiation with the notified body for incorporating the accumulative changes during the review process and the challenges when planning for global implementation. We will share our lessons learned, specifically some of the more challenging technical areas, e.g., biocompatibility; and provide recommendations on what to look out for during the technical documentation creation.
Learning Objectives:
Upon completion, participants will be able to gain insights on the EU MDR certification process from start to finish.
Upon completion, participants will be able to understand the nuances of the EU MDR certification so they can be more proactive in addressing the issues and avoid pitfalls.
Upon completion, participants should expect to undertake a smoother transition to EU MDR.
.jpg "Lucy Tan, MBA photo")
