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.
Tags
Organization
Country / Region
United Kingdom
License
Open Government Licence 2.0 (United Kingdom)