The impact of integrating artificial intelligence into regulatory affairs functions in the Medtech industry

INTRODUCTION: Artificial intelligence is becoming an important tool in the medical technology industry where its implementation has the potential to streamline processes and provide rapid and efficient data analysis and interpretation in the regulatory affairs function. AREAS COVERED: The adoption of Artificial Intelligence is emerging as a tool in the MedTech Regulatory Affairs function and the success factors and barriers to successful implementation are outlined. Empirical case applications and hands-on experiences of artificial intelligence are limiting factors in the adoption of AI. The factors for successful adoption include rigorous validation processes aligned with trustworthiness, transparency, and reproducibility. In addition, effective regulatory guidance and internal governance are required. Literature from the last two decades from 2016 to 2026 in relation to the above was reviewed from the Web of Science, SCOPUS, and MEDLINE academic databases. EXPERT OPINION: Currently, persistent barriers to artificial intelligence adoption are global acceptance by regulatory bodies for artificial intelligence-generated outputs, assuring compliance with the quality and interoperability of data across jurisdictions, data hallucinations, cost, training, and integration hinder the application of artificial intelligence. Cross-regional policy harmonization is an opportunity for the regulators as adoption broadens.