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:
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’.
