MDR in Practice: Ensuring Compliance in a Rapidly Evolving Regulatory Landscape

Abstract

The European Medical Device Regulation (EU MDR) has undergone significant reforms by mandating enhanced rigorous standards and continuous monitoring for clinical evaluation, post-market surveillance, quality management and lifecycle conformance. This paper looks to review the practical application of the MDR in a fast-changing regulatory landscape which is rife with technological innovation, digitalization, and rising patient safety expectations. A qualitative narrative literature review was used to collate available evidence for regulatory progression, clinical justification criteria, operational challenges, global harmonization, and digital-health related issues such as emerging trends associated with AI, IoT and cyber security. The review concludes that though the EU MDR engenders sustainability, transparency and quality, adoption has expanded a mandatory pre-market requirement to an organization-wide structure. It also concludes the importance of global harmonization and technology-centric regulation to drive innovation without compromising safety is crucial for sustainable progress.