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Updates on MHRA & COVID Test Validation Consultations

By October 22, 2021No Comments

MHRA Consultation – https://www.gov.uk/government/consultations/consultation-on-the-future-regulation-of-medical-devices-in-the-united-kingdom 

This remains open until 25 November and is a huge document with nearly 500 questions – not all will be relevant to IVDs but we need as many companies to respond as possible. You do not have to complete all the questions and even if you just respond to a few then this will increase the voice from the IVD sector. We have a spreadsheet of all the questions which might help you to circulate the responses around your own organisations before submitting them. It would also be helpful to see any issues for your company you’d like BIVDA to highlight in our response for the sector.

 

CTDA – COVID desktop validation

This week the new health minister, Maggie Throup MP put out a statement which has raised more questions than it has answered among companies who have submitted tests into the desktop validation legally required for products to remain on the UK market for COVID antigen and molecular tests. The GOV.Uk website has been updated to reflect changes and can be seen at:

https://www.gov.uk/government/publications/covid-19-test-validation-approved-products/medical-devices-regulations-2002-protocol

BIVDA continues to work with ABHI on this and we will be holding a webinar for members and are hoping that officials from the CDTA will be able to join to present to companies. In any case Steve Lee (ABHI) and Doris-Ann will be speaking directly to CTDA on Tuesday next week, in advance of the webinar on 28th October (2-3pm) to raise the concerns and questions you have been asking us over the last few days.

A notice was circulated today with a link to join the webinar – if you have not received this then please let Doris-Ann know and she will send it to you.

Michael

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