The new European Medical Device Regulation: Friend or foe for

Injury · Oct 2023

The new European Medical Device Regulation: Friend or foe for hospitals and patients?

The new EU Medical Device Regulation (MDR) was introduced in 2017 to increase the safety and quality of medical devices in the European Union. Theoretically, several hundred thousand medical devices must be approved under the new MDR guidelines, although the majority of these products have been and will be in daily use in countless operations on the European market for decades. The expected expenditure of time and money until the MDR is fully implemented is associated with high costs, patient disadvantages but also manufacturer problems. The following briefly summarizes the current situation in many European countries and presents the consequences for patients and hospitals and in this context also emphasizes the interdependence between hospitals, patients and manufacturers.

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- Andreas Nüssler.
- Eberhard Karls University Tübingen, BG Trauma Clinic, Siegfried Weller Institute of Trauma Research, Schnarrenbergstr. 95, 72076 Tübingen, Germany. Electronic address: Andreas.Nuessler@med.uni-tuebingen.de.
- Injury. 2023 Oct 1; 54 Suppl 5: 110907110907.
AbstractThe new EU Medical Device Regulation (MDR) was introduced in 2017 to increase the safety and quality of medical devices in the European Union. Theoretically, several hundred thousand medical devices must be approved under the new MDR guidelines, although the majority of these products have been and will be in daily use in countless operations on the European market for decades. The expected expenditure of time and money until the MDR is fully implemented is associated with high costs, patient disadvantages but also manufacturer problems. The following briefly summarizes the current situation in many European countries and presents the consequences for patients and hospitals and in this context also emphasizes the interdependence between hospitals, patients and manufacturers.Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.

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The new European Medical Device Regulation: Friend or foe for hospitals and patients?

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