Impact of Regulatory Changes on Innovations in the Medical Device Industry Comment on "Clinical Decision Support and New Regulatory Frameworks for Medical Devices: Are We Ready for It? - A Viewpoint Paper"

Abstract

Economic regulation is an instrument of the state or other institutions to correct market failures, rectify the business environment, or protect consumers. Regulation can be a major driver of innovation, and it has proven to be so in the past. On the other hand, there are also documented cases of ineffective regulation due to information delays or shortcomings in government decision-making. The complexity of the impact of regulatory changes on innovation can currently be observed in the medical device market in Europe. Regulation (EU) 2017/745 whose main idea is to ensure greater safety and health protection for consumers, is a challenge for originator, manufacturer, mostly small and medium-sized enterprises. The regulation is associated with an increase in the cost of developing and maintaining the product on the market. We can now gradually begin to analyze whether it can be ranked among those that have become drivers of innovation.

Clinical Decision Support and New Regulatory Frameworks for Medical Devices: Are We There Yet? A Response to the Recent Commentaries

“…2 Medical Ethics Committee, Universitair Ziekenhuis Brussel, Brussels, Belgium. 3 Gerontological Sciences (GERO), Vrije Universiteit Brussel (VUB), Brussels, Belgium.…”

“…Further challenges have been raised in subsequent commentaries. [1][2][3] In this correspondence, we discuss some of the many remaining challenges, and provide further thoughts on the regulation of artificial intelligence (AI) in healthcare.…”

The Challenges of Regulating Artificial Intelligence in Healthcare Comment on "Clinical Decision Support and New Regulatory Frameworks for Medical Devices: Are We Ready for It? - A Viewpoint Paper"

“…In an accompanying commentary, Maresova expanded on the regulation around medical devices in the European Union. 26 There is hope that the European Union's proposed Artificial Intelligence Act, which would be the first comprehensive regulatory scheme for artificial intelligence worldwide and would divide products into risk categories, will usher in a new era in the regulation of artificial intelligence and establish a global standard for regulators and manufacturers. 27 We agree with Van Laere and colleagues that neither set of regulators have yet clarified all of the issues that arise.…”