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

By Karen Hill and Evangeline Loh

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.

Proposed new approach for high-risk IVDs

The future regulatory amendments to the MDR 2002 include a proposed updated risk classification system. This new approach would involve obsoleting the common technical specifications referenced in the current MDR 2002, which applies to List A IVDs. Instead, the above-listed Class D IVDs, in the future regulatory amendments to the MDR 2002, will be able to use the CS requirements to demonstrate conformity with applicable essential requirements.

Proposed new approach for coronavirus

In addition, the CS requirements will include quality and technical requirements for SARS-CoV-2 IVDs, thereby eliminating the current CTDA process while continuing to ensure that all mature antigen and molecular detection COVID-19 IVDs adhere to minimum standards of performance to reduce the potential risk to public health.

MHRA consultation questions

The consultation comprises three questions:

• “Do you agree that the CS for certain Class D IVDs, as set out in the Commission Implementing Regulation (EU) 2022/1107, should be incorporated into the UK Medical Devices Regulation 2002?
• Do you think meeting CS requirements should be a requirement in a Post Market Performance Follow-up Plan?
• The Government proposes removing the requirements for Coronavirus test devices, from the MDR 2002. The Government proposes to require COVID-19 test devices to undergo a conformity assessment by an Approved Body, meeting Common Specifications requirements in line with Commission Implementing Regulation (EU) 2022/1107, the EU Common Specifications for certain Class D IVDs?”

MHRA consultation procedure and timeline

The consultation is open and closes on Friday, June 14, 2024. Responses to the consultation can be submitted online.

The MHRA intends to incorporate resulting updates in a draft statutory instrument as part of the future core medical device regulations to be published later in 2024, with the updated regulation anticipated to come into force in 2025.

Concluding remarks

This is a welcome development, bringing consistency with European Union (EU) regulations, and further contributing to global harmonization and a more streamlined process for manufacturers.

If you want your opinions considered, submit your responses before the deadline.