Since the enactment of EU MDR and the EU AI Act 1689, Artificial Intelligence enabled medical devices (AIeMD) now must ensure compliance with dual regulatory requirements. This research dissertation examined the current regulatory landscape that exists for developers and deployers of AI enabled medical devices (AIeMD) and sought to identify if the need exists for the development of a Strategic Framework of Compliance for AI enabled medical devices to EU MDR 745, the EU AI Act 1689. The primary research undertaken consisted of qualitative semi-structured interviews with MedTech industry professionals involved in the research, development, and regulation of AIeMD. A mixed methods approach was undertaken, with the data gathered from an industry survey of similar industry professionals used to compliment or present alternative views to those identified during the thematic analysis. In addition to this, secondary research was undertaken to assess the current landscape for AI enabled medical device conformity pathways and status of CE marking for a sample of AIeMD in each medical field using the FDA AI Medical Device Database and EUDAMED,A case study of the Medtronic O-Arm Surgical Imaging System which forms part of the “AiBle™” product offering from Medtronic was also used. Finally, a document analysis of EU MDR 745, and the EU AI Act 1689 was conducted to outline areas of harmonisation, and divergence within the two pieces of EU legislation. This mixed methods approach allowed for the delivery of a comprehensive interpretation of the current regulatory challenges that developers and deployers of AIeMD face, while also presenting the opportunities that AI technology now places on the global healthcare system to achieve the elusive quadruple aims in healthcare. The research revealed a strong lack of, and demand for, harmonised compliance frameworks that aid organisations in navigating a complex regulatory landscape, and the criticality that standards and guidance play in dual regulatory compliance.