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Common specification requirements for in vitro diagnostic devices

From:
Medicines and Healthcare products Regulatory Agency
Published
21 May 2024

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Summary

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

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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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Consultation on common specification requirements for in vitro diagnostic devices

PDF, 490 KB, 22 pages

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

PDF, 164 KB, 4 pages

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Published 21 May 2024

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