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 KempSeptember 11, 2024
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 KempSeptember 11, 2024
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 KempSeptember 11, 2024
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 KempSeptember 11, 2024
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 KempSeptember 11, 2024
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 KempSeptember 11, 2024
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 KempSeptember 11, 2024
The Council Decision (EU) 2024/2218 of 28 August 2024 on the signing, on behalf of the European Union, of the Council of Europe Framework Convention on Artificial Intelligence and Human Rights, Democracy and the Rule of Law can be found here.
Ben KempSeptember 11, 2024
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 KempSeptember 10, 2024