Please note this is an extract of the original bulletin.
COVID-19 test validation approved products
Page summary:
Find out which COVID-19 test products have been approved.
Change made:
Published updated ‘COVID-19 test validation approved products’ data.
Medical devices given exceptional use authorisations during the COVID-19 pandemic
Page summary:
List of manufacturers and their medical devices which have been granted an exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. This information will be listed for 2 months after expiry or cancellation.
Change made:
Open and closed lists have been updated.
COVID-19 test validation approved products
Page summary:
Find out which COVID-19 test products have been approved.
Change made:
COVID-19 test validation approved products spreadsheet updated.
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:
Published – Intertek Medical Notified Body UK Ltd Medical Devices Scope
Notify the MHRA about a clinical investigation for a medical device
Page summary:
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Change made:
Added information on fees payable in relation to clinical investigation and amendments to clinical investigations.
MORE Submissions – user reference guide
Page summary:
A step-by-step guide on using the MORE Platform for Submissions of device related incidents.
Change made:
Updated Submissions guidance to reflect: Update to screenshots, guidance for draft reports and auto-population of submitter fields.
MORE Registrations – user reference guide
Page summary:
A step-by-step guide on using the MORE Platform for Registrations for Submissions of device related incidents.
Change made:
Updated registration guide to include definition of ‘Workspace’.
