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Regulatory Affairs Newsletter Archive

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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
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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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The Research and Development Relief (Information Requirements etc.) Regulations 2024

These Regulations amend the Relief for Research and Development (Content of Claim Notifications, Additional Information Requirements and Miscellaneous Amendments) Regulations 2023 to restate the information that has to be provided by a company claiming relief from corporation tax in respect of expenditure on research and development (“R&D”). The changes they make reflect significant reforms to the R&D regime made by…
Ben Kemp
September 17, 2024
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2025 Regulatory Affairs Seminar

The Regulatory Affairs Seminar will be held on the 11th and 12 February 2025. BIVDA’s Regulatory Affairs Seminar brings together the UK’s leading regulatory specialists to learn and collaborate.  Next year’s event is being held at the Grand Hotel, Birmingham. Tickets are available at £895 per ticket, the event is currently NOT on Eventbrite so please signal your interest by…
Ben Kemp
September 17, 2024
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