Module 18 - Drug Device Combinations and Other Technologies

04/12/2023

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Legal Basis for Regulatory Classification

Copyright © 2022 BSI. All rights reserved

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Definition of medicinal product and medical device

Medicinal product

Medical device

Any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination…, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means but which may be assisted in its function by such means

Any substance or combination of substances having properties for treating or preventing disease in human beings; or used in or administered to human beings … by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis

Medical Devices Regulation (MDR) EU 2017/745

Medicinal Products Directive (MPD) 2001/83/EEC

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