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Medical devices mimicking medicinal products: the European Court of Justice confirms a strict stance

 Outlook   In early 2023, the European Court of Justice upheld a legal ruling from Germany challenging the status of two medical devices that consisted exclusively of chemical substances and resemble medicinal products. Certification bodies or authorities are justified in denying medical device status to products of this kind for which a lack of pharmacological action has not been demonstrated.
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©Prescrire 1 March 2024

Source: "Medical devices mimicking medicinal products: the European Court of Justice confirms a strict stance" Prescrire Int 2024; 33 (257): 81-83. Subscribers only.

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See also:

"Medical devices that
resemble medicines:
benefits for industry,
uncertainties for patients"
Prescrire Int 2021;
30 (231): 274-275.
Subscribers only


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