Growing Regulatory Complexity: An Innovation Challenge?

 The considerable rise in regulatory complexity within the global medical device manufacturing community is a challenge that keeps many leaders rethinking the right approach. While the European Union’s Medical Device Regulation (EU MDR) is at the forefront today, the issue certainly isn’t limited to the EU. Life sciences organizations have a choice with regulatory initiatives: spend the minimal amount to be compliant and live with a patchwork of “silo solutions” or look at challenges such as EU MDR as an opportunity to innovate and modernize information management practices. The increasing complexity of regulatory compliance requirements is consequential and requires a strategic, holistic versus tactical approach to deliver ROI over the long term.   Internal Factors May Intensify the Challenge In addition to external pressures, many device companies have internal challenges that intensify the issue. A 2018 Gens and Associates study of 72 companies revealed these factors that complicate the regulatory compliance roadmap for device participants: 72% report inefficiency with key regulatory information management capabilities such as submission document management, registration management, health authority interactions, and label compliance tracking. 60% take longer than a week to report key regulatory information (e.g., regulatory status of products at a specific manufacturing site, s...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news