GovWire

Open consultation: Common specification requirements for in vitro diagnostic devices

Medicines Healthcare Products Regulatory Agency

May 21
08:19 2024

MHRA is inviting members of the public, including the patients, medical device researchers, developers, manufacturers and suppliers, clinicians, other healthcare professionals to provide their views on the introduction of common specification requirements to the regulatory framework before IVD devices can be placed on the GB market. We are also seeking views on the removal of the Coronavirus Test Device Approval (CTDA) process to avoid duplication of regulatory requirements for COVID-19 tests against the Common Specification requirements.

Documents

Consultation on common specification requirements for in vitro diagnostic devices

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If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Summary of consultation questions on common specification requirements for In Vitro Diagnostic devices

Request an accessible format.
If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

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