Please note this is an extract of the original bulletin.
Implementation of medical devices future regime
Page summary:
A roadmap outlining the intended timelines for delivering a future regulatory framework for medical devices and an intended policy on international recognition.
Change made:
Updated to include intended policy on international recognition and consultation on common specifications for in vitro diagnostic medical devices (IVDs).
MHRA announces consultation on improved safety for high risk in vitro diagnostic devices
Page summary:
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (21 May 2024) launched a four-week consultation which will support improved safety for certain high risk in vitro diagnostic (IVD) devices.
Change made:
Changed to update link to: https://www.gov.uk/government/consultations/common-specification-requirements-for-in-vitro-diagnostic-devices
COVID-19 test approval: how to apply
Page summary:
How test manufacturers or distributors can apply for approval of their tests to sell on the UK market.
Change made:
Added links to COVID-19 test approval step 2: process for desktop review and list of comparator assays.
Medical devices given exceptional use authorisations during the COVID-19 pandemic
Page summary:
List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled.
Change made:
Updated list of medical devices given exceptional use authorisations
