Research and analysis

Medical Devices (Coronavirus Test) Regulations 2021: RPC Opinion

Regulatory Policy Committee opinion on DHSC's Draft Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021

• From: Regulatory Policy Committee
• Published: 21 July 2021

Documents

RPC Opinion: testing kits 2021

PDF, 142 KB, 8 pages

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Details

We note that the Department have issued a Written Ministerial Statement, alongside the red-rated Impact Assessment on the Draft Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021, to support the debate in Parliament. There are still a number of issues with the Department’s analysis which need to be addressed in order to achieve a fit for purpose (green-rated) IA that provides proper transparency over the impacts of the measure.

We look forward to continue working with officials from the Department to receive the IA on the above SI and issuing an opinion on it as soon as possible

Published 21 July 2021