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

June 2023RegulationHealthcare

Abstract

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.

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Authors

CarlosFrancisco Marin Barrios

Consultant, Obelis Group, Belgium

Tancredi Vergani

Consultant, Obelis Group, Belgium

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