Consultation outcome

Common specification requirements for in vitro diagnostic devices

From:
Medicines and Healthcare products Regulatory Agency
Published
21 May 2024
Last updated
10 July 2025 鈥� See all updates
This consultation has concluded

Read the full outcome

Government response to the consultation on the Common Specification Requirements for In vitro Diagnostic Devices

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Detail of outcome

This document analyses the responses to the public consultation on the proposed amendments to the Medical Devices Regulations 2002 regarding the Common Specifications requirements for certain high-risk in vitro diagnostic devices (IVD devices), including COVID-19 tests and the COVID-19 Test Device Approvals (CTDA) process.

The consultation ran from 20 May to 14 June 2024 and received 39 responses from various stakeholders, such as IVD device suppliers and producers, healthcare professionals, trade associations, individuals, and patient groups.

Original consultation

Summary

MHRA seeks views on possible amendments to the Medical Devices Regulations 2002 to include common specification requirements for manufacturers of IVD devices.

This consultation ran from
to

Consultation description

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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PDF, 490 KB, 22 pages

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PDF, 164 KB, 4 pages

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Updates to this page

Published 21 May 2024
Last updated 10 July 2025 show all updates

  1. Government response published.

  2. First published.

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