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UK MHRA: Med Dev Guidance on "Off-Label Use","Virtual Mfg." "Legal Requirements" & "Approved Bodies"

UK's Medicines and Healthcare Products Regulatory Agency (MHRA) this week (16,17 May 2023) released updated multiple guidances related to Medical devices.

This guidance is applicable to standalone software and apps placed on the Great Britain market (England, Wales, and Scotland). In this guidance, examples are shown within flowcharts to illustrate which standalone software and apps are medical devices, in vitro diagnostic devices, or implantable medical devices that require UKCA certification.

A Virtual Manufacturer is an organisation that fully sources its own named product from another company, which has designed and manufactured an identical UKCA/CE/CE UKNI marked product. This guidance recommendations and insights into the adoption of virtual manufacturing in the medical device industry and details about the Responsibilities of a virtual manufacturer and the technical documentation a virtual manufacturer needs to hold.

This guidance provides detailed information on the legal obligations and regulatory framework for manufacturers on the regulations that apply to prosthetic, orthotic, and ophthalmic devices.

Off-label use refers to the use of a medical device in a manner that is not specified or approved in its intended purpose or instructions for use. It involves using the device for a different indication, patient population, or treatment method than what is stated in the device's regulatory approval and the guidance details what is considered an off-label use of a medical device and provides examples of it.

This guidance provides information regarding the designation and role of approved bodies in the regulation and certification of medical devices and outlines the criteria and requirements for organizations seeking approval to act as notified bodies in the UK.


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