[Emergo, UL] MHRA Opens Public Consultation on Common Specifications for High-Risk IVDs

This week the UK medical device regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) announced the launch of a four-week public consultation seeking the views of various stakeholders to improve safety measures for high-risk IVDs by including Common Specification (CS) requirements in the UK legislation (Medical Devices Regulations 2002 (MDR 2002)). In addition, they also seek views on the removal of the Coronavirus (SARS-CoV-2) Test Device Approval (CTDA) process (desktop review) to avoid duplication with the CS requirements.

 

Overview of the Common Specifications Policy

The purpose of the CS policy is to improve the safety profile of high-risk IVDs requiring manufacturers to comply with additional measures to protect patients and public health before placing these IVDs on the market.

 

CS requirements are a minimum set of performance expectations, to ensure that when there are public health concerns on the safety or performance of certain high-risk IVDs, these can be addressed by requiring manufacturers to demonstrate the device complies with the CS requirements. These are highly specific technical requirements for certain high-risk IVDs, including IVDs detecting and/or quantifying HIV, human T-cell lymphotropic virus, hepatitis B, C and D variant Creutzfeldt-Jakob disease, cytomegalovirus, Epstein-Barr virus, the causative agents of syphilis and Chagas disease and SARS-CoV-2, as well as for determining various blood groups.

 

 

MHRA Opens Public Consultation on Common Specifications for High-Risk IVDs | Emergo by UL

MHRA Opens Public Consultation on Common Specifications for High-Risk IVDs

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