Yesterday(01 July 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidelines on the "Borderlines with Medical Devices & Other Products in Great Britain" that outlines whether or not your product is a medical device.
Generally, medical devices must meet the definition of a medical device, have a medical purpose, and operate without affecting metabolism, immunity, or pharmacology.
In the event that they affect these functions while serving a medical purpose, they are likely to be regulated as medicinal products rather than medical devices.
This guidance provides information regarding the distinction between medical devices and other products in Great Britain, specifically focusing on situations where there may be ambiguity or overlap.
It addresses the criteria that determine whether a product should be classified as a medical device or falls under different regulations, such as medicinal products or standalone software.
The guidance aims to clarify the boundaries and ensure proper regulation and compliance within the context of medical devices in Great Britain.
As specified in Part II of the Medical Device Regulations 2002 (as amended), this guidance document covers borderline products with general medical devices but does not cover borderline products with in vitro diagnostic devices or active implantable devices.
Software can be classified as a medical device if it aligns with the definition of a medical device. This definition encompasses standalone software as well as software used in conjunction with a device intended for diagnostic and/or therapeutic purposes. When software is intended for use alongside such a device, it is categorized as a medical device.
Click this LINK to more exclusively about this guidance.
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