Skip to main content
search
Category

Regulatory Affairs Newsletter

Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DEFRA Update (WC 19 Aug)

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 Kemp
August 21, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT Update (WC 19 Aug)

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 Kemp
August 21, 2024
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EU standard – Radio Equipment – Internet

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 Kemp
August 21, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

Conference: POCT-for-Scot: Bringing the future to you

Thursday 14th November - SEC Arena, Glasgow Join for a full day conference on the 14th November from 9am until 5pm. They will be bringing to you educational presentations, interactive discussion sessions and a product fair from a wealth of Point of Care manufacturers. Industry delegates are welcome to join and the registration fee is £125.40 including VAT. Please ensure…
Ben Kemp
August 21, 2024
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Cyber security in the health and medicine sector: a study on available evidence of patient health consequences resulting from cyber incidents in healthcare settings

This study reveals cyber vulnerabilities in the EU healthcare sector and further highlights the challenge of characterising cyber incidents in regard to their health consequences. Hurdles are a lack of consistent evaluation and reporting criteria and a lack of frameworks for assessing causality. We alert that such tools need to be developed in order to prepare for the rising risk…
Ben Kemp
August 21, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Updates (WC 19 Aug)

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: Added the following to the ‘List of medical devices given exceptional use authorisations’:Dolphin Fluid Immersion Simulation SystemAxiomTM Total Blood Typing Solution/Gene Titan™ Multi-Channel…
Ben Kemp
August 20, 2024
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EU: Council decision on AI, Human Rights, Democracy and the Rule of Law

Please see the EU Proposal for a COUNCIL DECISION on the signing, on behalf of the European Union, of the Council of Europe Framework Convention on Artificial Intelligence, Human Rights, Democracy and the Rule of Law. Note that that the UK is a Council of Europe member state.
Ben Kemp
August 20, 2024
Close Menu