US Perspectives on the EU Medical Device Approval System, and Lessons Learned from the United States

Abstract

The literature on the regulation of drugs at the FDA and the European Union is substantial, yet little research has provided comparative analyses and robust empirical data on the regulation of medical devices in the United States and the European Union. As medical and health markets become increasingly globalized, and the U.S. and the EU compete for leadership and recognition, salient domestic regulatory issues are becoming increasingly international and transnational policy issues. Building on Carpenter's (2010) work on drug regulation at the FDA, but taking a slightly narrower yet at the same time a broader approach by drawing on interdisciplinary studies instead of limiting ourselves to only the Political Science literature, this comparison focuses on key aspects of risk regulation and governance of medical devices in the U.S. and the EU, and shows how and why individual and organizational learning is imperative in each case.

Changes in the Medical Device’s Regulatory Framework and Its Impact on the Medical Device’s Industry: From the Medical Device Directives to the Medical Device Regulations

“…Hence it makes a great deal of sense to give more considerations to clinical data, clinical assessments, and make use of clinicians' experience with patient outcomes. 75 Nevertheless, (probably) in response to the stakeholders' constant requests of rendering the application of the MDR to legacy products more viable, one step back to the older approach has been taken in this regard. Indeed, on 22 March 2019 the MDCG published a document on the interpretation of Article 54(2)b of the Medical Devices Regulation, which states:…”