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Ben Kemp

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The Radio Equipment (Amendment) (Northern Ireland) Regulations 2024

The Radio Equipment (Amendment) (Northern Ireland) Regulations 2024 (legislation.gov.uk) The Windsor Framework requires that the European Union (“EU”) legislation listed in its Annex 2 is implemented in Northern Ireland. One of the Directives listed in Annex 2 is Directive 2014/53/EU of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating to…
Ben Kemp
October 15, 2024
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Brazil IVD News: Regulation updates

To help you navigate the Brazilian Health Regulatory Agency's (ANVISA) latest updates for in vitro diagnostics (IVDs) and the implications for your healthcare products, we highly recommend you review this detailed report by Patricia Urakawa, Senior Consultant of Regulatory Affairs at Emergo by UL. This invaluable resource explains several critical updates to RDC 830/2023 that you should be aware of,…
Ben Kemp
October 15, 2024
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CELEX:32024D2657: Council Decision (EU) 2024/2657

Two new harmonised standards have been added for IVD under the EU IVD regulation. In the Annex to Implementing Decision (EU) 2021/1195, the following entries are added: No ‘14. Reference of the standard EN ISO 13408-1:2024 Aseptic processing of health care products – Part 1: General requirements (ISO 13408-1:2023) No ‘15. EN ISO 20916:2024 In vitro diagnostic medical devices –…
Ben Kemp
October 15, 2024
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EPO free online event

Patents and innovation in European universities The IPO UK has contributed to a European Patent Office (EPO) “Patents and innovation in European universities” study. On the 22 October the EPO’s Observatory on Patents and Technology will be hosting an online event on technology transfer and academic innovation in Europe, to mark its first anniversary. This event brings together key stakeholders…
Ben Kemp
October 15, 2024
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Media Monitoring: 10 – 16 October

Towards an FP10 Fit to Tackle Global Challenges: The UK’s position on the Successor to the World’s Largest R&D Programme DSIT Secretary, Peter Kyle MP, stated that the Government wants to strengthen ties with their European neighbours and explore areas where they can boost shared prosperity and security through mutually beneficial agreements. This includes ensuring that UK scientists, innovators, businesses,…
Ben Kemp
October 15, 2024
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The Darzi Review debated in the Commons

Last week, the Health Secretary, Wes Streeting MP, laid out the findings of Lord Darzi's review into the performance of the NHS in Parliament. This is the first opportunity that MPs have had to debate the issue in the Commons. Many members understandably raised their concerns about the state of general practice, notably the lack of GPs and therefore appointments…
Ben Kemp
October 15, 2024
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