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MHRA request for possible repercussions of UKCA Regulations

By April 8, 2022No Comments

Doris-Ann, Ashleigh and the Chairs of the Regulatory Affairs Working Party met with the senior leadership of MHRA on 1 April. The aim of the meeting was to discuss the ongoing changes affecting the IVD industry, such as the changes to the structure of MHRA and the upcoming UKCA Regulations.

MHRA provided reassurance that they are trying to move as quickly as they can in releasing the new regulatory structure, but due to the UK Government entering the pre-election period, they are currently not able to share policy positions. The response to the consultation is therefore expected after 9 May, and no date has been provided for the full draft regulations. They also clarified that the changes within MHRA as an organisation continue to have patient safety at the forefront.

As part of this discussion, MHRA requested BIVDA to provide case study and evidence of the possible repercussions that could arise if the UKCA Regulations diverge greatly from existing legislation. This evidence will be used to identify what the major concerns are and may impact the draft regulations.

A template has been produced for members to list the possible impacts for your company specifically (for example, if you cannot place product on the market due to shortage of Approved Bodies, this would mean 30% of diagnostic tests for breast cancer would be lost to patients).

Evidence and data were also requested on the anticipated future volume of IVDs on the market to demonstrate the possible capacity required for UKCA marking. The same excel document includes a template for inputting predicted future sales and workforce capacity for diagnostics to provide this.

Members are requested to please complete this excel document and return it to Ashleigh by 15 April.

All data provided to BIVDA will remain confidential. When this is submitted to MHRA all data will be anonymised, and no organisation names will be provided.


Ben Kemp