Needs, Challenges, and Obstacles in the Implementation of the EU Medical Device Regulation

Carlos Francisco Marin Barrios , Consultant, Obelis Group, Belgium

The Medical Device Regulation (MDR) 2017/745 is a novel piece of legislation intended to govern the high-tech commercial domain of medical devices in the European Union to the highest possible degree. Even six years after its publication on 5 April 2017, the motive, feasibility, and consequences continue to be the subject of intense debate.

Carlos Francisco Marin Barrios is jurist specialised in EU law and international business management. He studied Law and Public Management at the University of Seville in Spain, holds a Master of Laws from the University of Antwerp in Belgium, and a Master in Exercise of the Legal Profession and Legal Consultancy Company from the International University of La Rioja in Spain. He has gained academic and professional experience in Spain, England, Germany, and Belgium. Since 2019, Carlos works at Obelis as an Expert Consultant in Regulatory Affairs and Quality Assurance.

Obelis is Europe’s largest company for CE Marking and representation services in the European Union, United Kingdom, and Switzerland. Founded in 1988, Obelis is a member of various EU associations and European Commission working groups. With special expertise in the compliance process of medical devices, Obelis owns and manages MDlaw.eu, the regulatory information platform on medical devices and in vitro diagnostics medical devices.