Update to The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021
The next stage of the validation process for COVID 19 in vitro diagnostic devices (test kits) is being developed. This will bring in a mandatory laboratory verification for all COVID 19 test kits - this will be in addition to the existing requirement for desktop evaluation by a scientific assessor. We intend to lay regulations in November with them coming into force before the end of the year.
As we developing the second stage we would welcome any comments or views. Ideally via the consultation or call for evidence process but also directly.
DATES: 23/8/21 to 01/10/21