The FDA have published their Guidance regarding the eSTAR template for Medical Device De Novo Submissions.
Ben KempAugust 27, 2024
The European Commission has suggested revising the common specifications for certain class D in vitro diagnostic devices to address tests for specific parasites and viruses of public health importance. Stakeholders have a four-week period to provide feedback on these proposed changes. On 19 August, the Commission released the proposed amendments, which, if approved, would update the In Vitro Diagnostic Medical…
Ben KempAugust 27, 2024
The MHRA have uploaded their webinar covering the AI Airlock from July, which may be of interest to members. The webinar provides a helpful overview of the utilisation of the Airlock for the development of AI IVDs. It can be accessed here.
Ben KempAugust 23, 2024
Safety and security requirements on imports and exports Page summary: Find out about safety and security requirements that apply to goods entering and exiting the UK. Change made: References to Customs Handling of Import and Export Freight (CHIEF) system have been removed as all import and export declarations must now be made through the Customs Declaration Service. Time updated: 3:40pm,…
Ben KempAugust 21, 2024
AI Upskilling fund Page summary: The AI Upskilling fund pilot scheme will support small and medium-sized enterprises (SMEs) by match-funding AI skills training for their employees. Change made: Added details of a drop-in webinar on Wednesday 14 August 2024. Time updated: 3:32pm, 12 August 2024 Cyber Essentials management information Page summary: Figures showing the number of Cyber Essentials certificates awarded,…
Ben KempAugust 21, 2024
UK REACH authorisation for Abbott Laboratories Ltd, 3 July 2024 Page summary: Decision on application for authorisation under UK REACH. Change made: First published. Time updated: 12:00pm, 12 August 2024 UK REACH authorisations for Siemens Healthcare Diagnostics Products GmbH, 3 July 2024 Page summary: Decision on application for authorisations under UK REACH. Change made: First published. Time updated: 12:00pm, 12…
Ben KempAugust 21, 2024
Trade barriers: what you need to know Page summary: Find out what trade barriers are and how they may affect you when exporting goods or services. Change made: Link to information about ‘harmful international trading practices’ added to the ‘further information’ section of the page. Time updated: 11:48am, 12 August 2024 CPTPP: impact assessment Page summary: This impact assessment sets…
Ben KempAugust 21, 2024
EN 18031-1:2024 - Common security requirements for radio equipment - Part 1: Internet connected radio equipment (publication date=2024-08-14) View article... EN 18031-2:2024 - Common security requirements for radio equipment - Part 2: radio equipment processing data, namely Internet connected radio equipment, childcare radio equipment, toys radio equipment and wearable radio equipment (publication date=2024-08-14) View article... These have been adopted as…
Ben KempAugust 21, 2024