Lateral Flow

Hi everyone welcome, as it says above, to the blog.

Busy at the moment with antigen and antibody lateral flow tests and registration with the MHRA. A number are also going down the Department of Health and Social Care route by having their devices validated at Porton Down.

On this front there are changes on the horizon as the Government is looking to standardise the acceptance criteria for all COVID-19 lateral flow tests. This is still in discussion as I type but looks like it will be happening by August / September 2021.

Keep safe and if you have any questions please get in touch.

Jonathan P

Posts tagged UDAMED

EUDAMED becomes mandatory on 28 May 2026: what manufacturers need to do now

EU MD, Regulatory UpdatesJonathan PhillipsMay 5, 2026UDAMED, EU MDR, IVDR, medical devices, regulatory compliance, Northern Ireland, Windsor Framework, Authorised Representative, PRRC, UK Responsible PersonComment