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Regulatory Affairs Newsletter Archive

FDA Webinar 24th October – Total Product Life cycle oversight of IVDs FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

FDA Webinar 24th October – Total Product Life cycle oversight of IVDs

FDA is hosting a webinar on 24 October on its total product life cycle (TPLC) oversight of in vitro diagnostics (IVD). Stakeholder questions need to be submitted by email by 23 September.
Ben Kemp
September 11, 2024
MHRA Updates (WC 9 Sept) Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Updates (WC 9 Sept)

Notify MHRA about a clinical investigation for a medical device Page summary: Information on how to notify the MHRA of your intention to carry out a clinical investigation for medical devices. Change made: Updated ‘In Vitro Diagnostic Medical Devices (IVDs)’ section, Time updated: 8:55am, 6 September 2024
Ben Kemp
September 11, 2024
Office for Product Safety and Standards Updates (WC 9 Sept) Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Office for Product Safety and Standards Updates (WC 9 Sept)

Designated standards: machinery Page summary: Notices of publication and a consolidated list for designated standards for machinery. Change made: Notice of publication amended and consolidated list updated. Time updated: 12:05am, 6 September 2024
Ben Kemp
September 11, 2024
DBT Updates (WC 9 Sept) Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT Updates (WC 9 Sept)

General Trade Licence for sanctioned Russian diamonds processed in third countries Page summary: The General Trade Licence for sanctioned Russian diamonds processed in third countries permits certain activities prohibited under the Russia (Sanctions) (EU Exit) Regulations 2019. Change made: General Trade Licence for processed diamonds updated to reflect changes in legislation. Time updated: 12:00am, 1 September 2024 Notice to Importers…
Ben Kemp
September 11, 2024
DSIT Updates (WC 9 Sept) Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT Updates (WC 9 Sept)

Cyber security breaches survey: 2025 Page summary: An annual survey about the experience and impacts of cyber breaches and attacks on organisations. Change made: Updated with Ipsos privacy notice for businesses and the privacy notice for charities and educational institutions. Time updated: 11:46am, 3 September 2024 Evaluating browser-based cookie setting options Page summary: A study exploring UK consumers preferences and…
Ben Kemp
September 11, 2024
Brexit Updates (WC 9 Sept) Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Brexit Updates (WC 9 Sept)

UK-EU Trade and Cooperation Agreement: Trade Partnership Committee meeting, 7 December 2023, minutes Page summary: These are minutes from the third meeting of the Trade Partnership Committee under the UK-EU Trade and Cooperation Agreement. Change made: First published. Time updated: 12:00pm, 2 September 2024 Trade and Cooperation Agreement Governance Page summary: This page provides information on the activity of the…
Ben Kemp
September 11, 2024
New Schengen entry requirements (planned for November 2024 onwards) European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

New Schengen entry requirements (planned for November 2024 onwards)

From November 2024, the new EU Entry/Exit System (EES) will start for all non-EU nationals, including British nationals, travelling in or out of the Schengen area. The Schengen area is made up of 29 European countries, 25 of which are EU Member States. The EES is a digital border system which registers non-EU visitors travelling into the Schengen area instead…
Ben Kemp
September 11, 2024
MHRA Fees Consultation Response BIVDA updates Regulatory Affairs NewsletterBIVDA Updates Regulatory Affairs Newsletter ArchiveMembership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

MHRA Fees Consultation Response

The MHRA recently announced a consultation on their statutory fees, running until 24th October. BIVDA have significant concerns about the suggestion of charging per GMDN code. As drafted, this could see fees increasing dramatically - from low hundreds of pounds to tens of thousands annually. The current regulatory transition may also see duplicate charging, where the same device is currently…
Ben Kemp
September 10, 2024