Within the next few years, the Medical Device industry will need to adapt to the Medical Device Regulations (MDR). The transition period to MDR began in 2017 and completed by 2025. These regulations have implications for Device Manufacturers, Notified Bodies, Competent Authorities as well as Ethic Committees.
Two key changes, execution of clinical trials and data submission requirements, if not properly planned for and dealt with, impose serious risks for business continuity.
During our webinar, we will explain what new MDR requirements mean for Clinical Trial setup and execution. We will also dive into Data and Submission requirements relating to UDI and labeling and provide you with valuable insights on how to best prepare and allow you to understand what you are required to do as a company to ensure compliance.
We will address practical questions you might have concerning your Clinical Trials, data submissions, and labeling, including:
- Is my current trial setup sufficient to meet upcoming MDR requirements?
- What is UDI and what do I to do about it?
- How does this impact my labeling activities?