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MHRA 04003 - Comparison GXR Systems - 2004 - Includ Radiotex-P4

The MHRA Device Evaluation Service evaluates medical devices in the UK, providing summaries of evaluations based on X-ray systems. The report includes quantitative and qualitative data, ensuring manufacturers maintain device specifications, but does not reflect any modifications post-evaluation. Additionally, the service does not access confidential regulatory information and does not influence regulatory investigations related to medical devices.

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Juan Espinoza
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20 views1 page

MHRA 04003 - Comparison GXR Systems - 2004 - Includ Radiotex-P4

The MHRA Device Evaluation Service evaluates medical devices in the UK, providing summaries of evaluations based on X-ray systems. The report includes quantitative and qualitative data, ensuring manufacturers maintain device specifications, but does not reflect any modifications post-evaluation. Additionally, the service does not access confidential regulatory information and does not influence regulatory investigations related to medical devices.

Uploaded by

Juan Espinoza
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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MHRA and the Device Evaluation Service

Policy statement
The Medicines and Healthcare products Regulatory Agency (MHRA) Device
Evaluation Service provides evaluation of medical devices available within the UK.
This report contains the summaries of evaluations that represent the quantitative and
qualitative data obtained from one or more X-ray systems during a type test. The
manufacturers have been asked to ensure their devices are operating within
specification and therefore the results should be representative of any identical models
of this device. Evaluation data in the report does not take account of any
modifications to the device since the evaluation. Where data on other similar devices
have been included for comparative purposes, the data will usually be identical to
those originally published; any exceptions will be highlighted.

The MHRA Device Evaluation Service does not have access to any information held
by the Agency in its capacity as the Competent Authority for the UK, apart from any
information already in the public domain. The reports will contain data given by the
manufacturer on the regulatory status of their devices but apart from this, they are not
an indicator of the regulatory status of a product. Occasionally, the Device
Evaluation Service refers products to the regulatory arm of the MHRA for
consideration of breaches of the legislation governing medical devices. The Device
Evaluation Service plays no further part in any regulatory investigation that ensues
and does not have advance notification of any regulatory action that may follow.

KCARE report: Comparative specifications of general radiography systems

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