Borderline products: how to tell if your product is a medical device and which risk class applies

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Health And Social Care

Published

January 6, 2021

Last updated

July 11, 2023

Description

How the MHRA makes decisions on when a product is a medical device (borderline products), and which risk class should apply to a medical device.

Organization

Country / Region

United Kingdom

License

Open Government Licence 2.0 (United Kingdom)

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