The MHRA recently announced that the current CTDA (Coronavirus Test Device Approvals) process for approval of SARS-CoV-2 tests is intended to be repealed with the introduction of the pre-market statutory instrument. Once Parliament agrees the statutory instrument, the MHRA have confirmed that the CTDA regulations will no longer apply from when the statutory instrument is made into legislation. They anticipate this to be Spring 2026.
At that time, the performance requirements described in the current UK MDR 2002 will be replaced by the EU Common Specification Annex XIII. The MHRA will not be assessing IVD tests for SARS-CoV-2 and will cease the CTDA process altogether. Instead, IVD tests for SARS-CoV-2 will be assessed by UK Approved Bodies or EU Notified Bodies following the performance requirement of the EU Common Specification Annex XIII, as applicable.
Before the MHRA removes the CTDA process, they will introduce an accelerated process for COVID-19 devices which have CE marking under the EU IVDR. They are planning to release details of the accelerated process in September. Applications already submitted will follow the existing CTDA process.
