Abstract 

The rapidly evolving medical technology (MedTech) landscape requires innovators to navigate an increasingly complex regulatory framework in order to bring medical devices to market, and ultimately to patients, in an efficient and safe manner.  

This article looks at the areas of risk-based quality management, clinical evidence generation and stakeholder engagement across the product lifecycle from the professional viewpoints of a regulatory consultancy, an Approved Body and a MedTech start-up, and examines key challenges and practical strategies for compliance under EU and UK Medical Device Regulations. Through a mix of regulatory analysis and real-world experience, including a first-hand case study of the EarSwitch™ developmental journey, this article contains actionable guidance for developers, quality professionals and regulatory teams working to accelerate market access without compromising patient safety or product integrity. 

This article leads on from insights shared recently in the TOPRA/BSI sponsored webinar ‘Innovative medical devices: How to navigate the regulated MedTech landscape to place these on the market’.