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Get Ahead of AI Regulations – EU AI Act Training

AI is becoming an integral part of our daily lives, and its governance affects everyone, from tech giants to individual users. Qserve will host a two-day AI Act training in Amsterdam, The Netherlands. Qserve and Industry Experts will explore this pivotal legislation and its implications for the medical device and IVD sectors during this training. Speakers include Gert Bos, Coenraad Davidsdochter,…
Ben Kemp
September 18, 2024
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Action needed now if you use EPO online filing!

Do you use EPO Online Filing (eOLF)? Things are changing on 30 September!  From 1 October 2024, you will no longer be able to renew eOLF Smart Cards that have expired. To continue filing with the IPO via eOLF, you will need to replace your smart card with a ‘soft certificate’. From 1st January 2025, valid smart cards will no…
Ben Kemp
September 18, 2024
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BSI – Rollout of EU Reference Laboratories for Class D IVDs

As part of BSI Regulatory Services, Medical Devices commitment in maintaining IVDs manufacturers up to date on the EU regulatory framework developments, we issue this communication in regard of the rollout of EU Reference Laboratories and oversight of Class D IVDs in Europe. On 5 December 2023, five EU reference laboratories (EURLs) have been designated through Commission Implementing Regulation (EU)…
Ben Kemp
September 18, 2024
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MHRA Update (WC 16 Sept)

MHRA consultation on statutory fees – proposals on ongoing cost recovery Page summary: Consultation on proposals to update the MHRA’s statutory fees to ensure they continue to recover their costs. Change made: Following early feedback from customers and stakeholders, we have clarified some terms in the consultation document relating to Priority 2: The MHRA proposes to amend its existing Medical…
Ben Kemp
September 18, 2024
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DHSC Update (WC 16 Sept)

ICAI review of DHSC's aid-funded global health research and innovation: government response Page summary: The UK government response to the Independent Commission for Aid Impact’s July 2024 recommendations on DHSC’s aid-funded global health research and innovation. Change made: First published. Time updated: 12:26pm, 10 September 2024 PM: ‘Major surgery, not sticking plaster solutions' needed to rebuild NHS Page summary: The…
Ben Kemp
September 18, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT Update (WC 16 Sept)

Joint minutes of the first UK-New Zealand Environment and Climate Change Sub-Committee Page summary: A summary of the discussions from the first UK-New Zealand Environment and Climate Change Sub-Committee including key points and recommendations. Change made: First published. Time updated: 2:18pm, 9 September 2024 UK, US and Australia sign supply chain resilience pact Page summary: The United Kingdom, United States…
Ben Kemp
September 18, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT Updates (WC 16 Sept)

South Korea: UK Science and Innovation Network summary Page summary: A summary from UK Science and Innovation Network (SIN) on science and innovation in South Korea including UK SIN priorities and successes. Change made: The ‘South Korea: UK Science and Innovation Network Summary’ has been updated. Time updated: 7:26am, 11 September 2024 Data centres to be given massive boost and…
Ben Kemp
September 17, 2024
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Team NB Position Paper – Transfer Agreement for PMS of legacy devices

Team NB have developed a position paper and template for the transfer of surveillance of legacy devices. This tripartite agreement template is regarding the transfer of responsibilities between notified bodies for certified IVD legacy devices subject to transitional arrangements, under the EU IVDR Article 110 You can find the paper here.  
Ben Kemp
September 17, 2024
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