Some of the members of the Life Sciences team here at LexisNexis Reed Tech were fortunate enough to attend the RAPS Convergence 2024 Conference in Long Beach, CA in September. In addition to networking and connecting with some of our customers, colleagues and alliances, our team was sure to attend many sessions to soak in as much knowledge as possible. Below are some of our key takeaways.
Overall, the focus was heavy on the transformative period of the Medical Device industry, driven by the rapid advancement of artificial intelligence (AI) and the implementation of stringent regulations such as the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). These developments are reshaping the way devices are developed, regulated and utilized, presenting both challenges and opportunities for manufacturers and stakeholders alike.

AI: A Game-Changer in Device Development and Capabilities
AI has emerged as a pivotal technology, poised to enhance device development functions and capabilities, while also streamlining regulatory review processes. As AI continues to evolve, it holds the potential to revolutionize the medical device industry, enabling more efficient and effective product development, enhanced device performance, and improved patient outcomes.
EU MDR/IVDR: A Regulatory Landscape in Flux
The EU MDR and IVDR have introduced a new era of stringent regulations, aimed at ensuring the safety and efficacy of medical devices and in vitro diagnostics. While remediation activities have been slow in 2024, expectations are high for a significant uptick in efforts come 2025. Device manufacturers have reported multiple challenges in implementing these regulations, including the complexities of compiling comprehensive Technical Files for compliance assessment.
Notified Bodies: Navigating the Bottleneck
Notified Bodies, responsible for assessing and certifying medical devices under the EU MDR/IVDR, have raised concerns about the industry’s pace in delivering Technical Files. This delay has the potential to create a bottleneck, underscoring the urgency for manufacturers to prioritize compliance efforts and meet the regulatory deadlines.
Expert Advice: Start Now or Risk Missing Deadlines
Experts in the field have unanimously advised manufacturers to initiate their compliance efforts immediately, emphasizing the risks of missing critical deadlines. Procrastination could lead to significant disruptions in product availability and market access, ultimately impacting patient care and safety.
Digital Transformation: Embracing the Future
The industry is witnessing a shift towards digital transformation, with initiatives like the US Device eSTAR Program and the EMA ePIL/FHIR pilot project gaining traction. These efforts aim to facilitate the delivery and utilization of device data in digital formats, such as electronic Patient Information Leaflets (ePILs). Embracing digital solutions can streamline processes, enhance data accessibility, and improve overall efficiency.
Laboratory Developed Tests (LDTs): A Pressing Concern
While the focus has been primarily on the EU MDR/IVDR and digital transformation, Laboratory Developed Tests (LDTs) have received limited attention despite their urgent compliance requirements. As these tests play a crucial role in patient care, addressing their regulatory compliance should be a priority for stakeholders in the industry.
As the medical device landscape continues to evolve, manufacturers and stakeholders must remain vigilant, proactive and adaptable. Embracing AI, prioritizing regulatory compliance and leveraging digital solutions will be key to navigating this transformative period successfully, ensuring patient safety and driving innovation in the industry.
To learn more, contact us at Reed Tech // [email protected] or +1(215) 557-3010.