Operation of the health institution exemption (HIE) – IVDR and MDR (Northern Ireland)

Name: Operation of the health institution exemption (HIE) – IVDR and MDR (Northern Ireland)
Creator: Medicines and Healthcare products Regulatory Agency
License: https://www.nationalarchives.gov.uk/doc/open-government-licence/version/2/
Keywords: eu,european-union,exemptions,guidances,in-vitro-diagnostics-regulation,ivdr,mdr,medical-devices,medical-devices-regulations,mhra,northern-ireland

Information

Original link

Type

Guidance

Regulated products

IVDMD, Medical Devices

Topics

Brexit, Health And Social Care

Published

January 1, 2021

Last updated

January 1, 2021

Description

The EU has published guidance on exemptions for medical devices manufactured and used within EU health institutions, which applies to Northern Ireland-based health institutions, replacing interim guidance from the MHRA.

Organization

Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧

Country / Region

United Kingdom

License

Open Government Licence 2.0 (United Kingdom)

Feedback

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1 Main file

WITHDRAWN: MHRA guidance on the health institution exemption (HIE) – IVDR and MDR (Northern Ireland)

Updated on January 1, 2021

pdf

URL: https://assets.publishing.service.gov.uk/media/65a54e2164060200143cb69a/NI_HIE_Guidance_-_withdrawn.pdf
Permalink: https://data.openrid.co/en/datasets/r/aa70ae56-e35e-4700-a161-718eaf16dbef
MIME Type: application/pdf

Created on: January 1, 2021
Modified on: January 1, 2021