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The UKCA sub-group met on 29 November for the first time in over a year. This group had been paused due to insufficient information on UKCA in recent time but has now been restarted as we are expecting discussions around UKCA and the future requirements to increase substantially.

The meeting itself had a fantastic turnout and a lot of interesting discussion. It included a recap of what we know so far about the future UKCA regime, and how BIVDA can help support members further in this area.

The purpose of the group is to explore how best to support MHRA with the process for the generation of a new regulatory framework for the UK. These meetings are to disseminate relevant UKCA updates to BIVDA members and discuss any practical challenges for implementation.

Information will still be provided within the Regulatory Affairs Working Party meetings on UKCA, but at a higher level than has been provided over the past year.

This group is intending to meet bi-monthly for the foreseeable future giving the scale of change coming in Great Britain for IVDs.

For any questions on this please contact Ashleigh. If you would like to be included in the circulation list for this UKCA sub-group and are not currently, please contact Natalie to be added.

Natalie Creaney