To overcome the slow, expensive EU/UK medtech landscape, unified electronic submissions must be established, delivering faster IVD/MD approvals and improved patient access.
The positive impact of digital tech in shaping this future landscape includes:
- How optimizing pre-submission reduces time by 30%, accelerating SaMD launches
- Reducing manufacturing and certification costs with electronic submissions
- The impact of standardized formats on data interoperability, efficiency and consistency for notified bodies
- UK regulatory landscape outlook and how harmonizing EU and UK submissions creates opportunity
- eCTD adoption - reducing timelines and increasing submissions
- The role of AI in enhancing regulation when facilitated by standardized data
- Recommendations for improving regulatory processes for IVDs and MDs