European medical device regulation: Perfection is achieved, not when there is nothing more to add, but when there is nothing left to take away

Author:

Paulus WalterORCID

Funder

Horizon Europe

JPND

Publisher

Elsevier BV

Reference5 articles.

1. The consequences of the new European reclassification of non-invasive brain stimulation devices and the medical device regulations pose an existential threat to research and treatment: An invited opinion paper;Antal;Clin Neurophysiol.,2024

2. Comparison of the international regulations for medical devices-USA versus Europe;Fink;Injury,2023

3. The PIP scandal: an analysis of the process of quality control that failed to safeguard women from the health risks;Martindale;J R Soc Med,2013

4. Should medical devices be regulated as rigorously as drugs?;Ung;Can J Hosp Pharm,2019

5. Wien P, Steckeler J, Benad N. Current assessment of the German medical device manufacturers on the effects of the EU Medical Device Regulation (MDR). Deutsche Industrie- und Handelskammer DIHK (German Chamber of Commerce and Industry) 2023.

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