Medicinal products, medical devices, or accessories of medical devices: How to qualify gases for spirometry?

نویسندگان

چکیده

European legislation provides that each product used for healthcare purposes be regulated according to specific directives and regulations based on its intended use mechanism of action. However, qualification issues may arise medical devices, their accessories, medicinal products. This is the case with gases spirometry, which support spirometers in measuring patients’ pulmonary capacities. article discusses criticisms connected proper regulatory qualification, detailing why they should more properly qualified as accessories devices instead products or devices.

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ژورنال

عنوان ژورنال: Frontiers in drug safety and regulation

سال: 2022

ISSN: ['2674-0869']

DOI: https://doi.org/10.3389/fdsfr.2022.1089965