Guidance Document
RESMAG has issued a new Guidance Document “Application of the health institution exemption (HIE) to Rehabilitation Engineering. The health institution exemption (HIE) is a part of the Medical Device Regulations (2017/745) that are currently due to be fully implemented in 2021.
These guidelines have been produced by RESMaG to assist Rehabilitation Engineering services apply the Medical Device Regulations (MDR 2017/745), specifically the health institution exemption (HIE), according to Article 5.5.
This document provides an interpretation of the Medicines and Healthcare products Regulatory Agency (MHRA)’s draft guidance for medical devices manufactured or modified and used within health institutions. The MHRA draft guidance was published for consultation which ran from January 2018 to March 2019. It is recommended that reference should be made to the MHRA website to access the latest version of the official guidance.
The work to produce this guidance involved input and review from several RESMaG members who represent a range of Rehabilitation Engineering services in the NHS and private sector.
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