Designing globally compliant medical devices: Bridging FDA and EU MDR requirements

The expanding complexity of medical equipment, software, and hardware, connectedness, and artificial-intelligence functions have augmented regulatory threats at jurisdictions. The necessity to develop harmonized compliance with the regulations such as the U.S. Food and Drug Administration (FDA) and the EU Medical devices Regulation (MDR 2017/745) is currently a worldwide success in designing the device, but the differences create an issue as to effective innovation and access to the market. The paper provides a synopsis of the regulatory convergence practices and experiences and provides an impression of a global design-compliance framework in which regulatory input, design translation, clinical-evidence planning, risk management, technical documentation and lifecycle surveillance is incorporated. As implied by exemplary types of machinery, the empirical research evidence demonstrates that the single model reduces regulatory loopholes, flattens the review process and strengthens documentation completeness. The paper concludes with certain strategic suggestions and future research directions that will solve emergent technologies, data-based evidence, harmonization initiatives and implementation lines.