Please note this is an extract of the original bulletin.
How tests and testing kits for coronavirus (COVID-19) work
Page summary:
The different types of tests and testing kits for COVID-19, and the specifications for manufacturers.
Change made:
The guidance on performing variant analysis for manufacturers of SARS-CoV-2 screening and diagnostic assays has been updated. Updated guidance documents are included for molecular and antigen tests as well as proformas to be completed every 60 days.
Medical devices: UK approved bodies*
Page summary:
UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).
Change made:
Added 3 pdfs: ABTUV RH2571InvitroDiagnosticMedicalDevices_ScopeTUV Rheinland UK Limited Medical Devices ScopeTUV SUD BABT Unlimited Medical Devices Scope.
*Please see the separate article on this.
