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Regulatory Affairs Newsletter Archive

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CLSI EP12

Evaluation of Qualitative, Binary Output Examination Performance, 3rd Edition This guideline includes descriptions of the types of qualitative, binary output examinations and procedures for evaluating their performance. This edition of the document was corrected in February 2024. Read the correction notices by accessing the link above, and learn more about our correction process here. Find out more here.
Ben Kemp
October 16, 2024
Other Updates Regulatory Affairs NewsletterOther Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Section 524B: Navigating Healthcare Cybersecurity Compliance

As the intersection of healthcare and cybersecurity continues to play a vital role in safeguarding patient data and the integrity of medical technologies, it is crucial for professionals in the healthcare sector to stay well-informed about legislative directives such as Section 524B. Are you a professional involved in medical software development and medical technology device manufacturing? Then this on-demand webinar…
Ben Kemp
October 16, 2024
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Prepare for ISO 42001 webinar

There's still time to register for our upcoming webinar: Prepare for ISO 42001 – a framework for the management of AI. In this session we will discuss how organizations can proactively prepare for upcoming AI regulations by implementing the right processes and controls. This webinar is ideally suited for professionals across a wide range of industries that are looking to…
Ben Kemp
October 16, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Medicines and Healthcare products Regulatory Agency Update (WC 13 Oct)

MHRA Corporate Plan: 2023 to 2026 and Business Plan: 2023 to 2024 Page summary: These reports outline the MHRA’s Corporate and Business Plans, detailing the agency’s strategic direction over the next three years. Change made: Published MHRA Business Plan: 2024 to 2025 Time updated: 3:32pm, 7 October 2024 MHRA launches 2024/25 business plan with focus on enabling access to groundbreaking…
Ben Kemp
October 16, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Office for Product Safety and Standards Update (WC 13 Oct)

Standardisation Page summary: Standardisation explained. Change made: New Memorandum of Understanding between DBT and BSI added. Time updated: 10:08am, 7 October 2024 Common charger for electrical devices: call for evidence Page summary: We are inviting views on the introduction across the UK of a common charger for mobile phones and other portable electrical and electronic devices. Change made: First published.…
Ben Kemp
October 16, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Business and Trade Update (WC 13 Oct)

Standardisation Page summary: Standardisation explained. Change made: New Memorandum of Understanding between DBT and BSI added. Time updated: 10:08am, 7 October 2024 End-user undertaking (EUU) form Page summary: End-user undertaking form which must be completed to comply with standard individual export licence (SIEL) and standard individual trade control licence (SITCL) terms and conditions. Change made: End user undertaking form has…
Ben Kemp
October 15, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Science, Innovation and Technology Update (WC 13 Oct)

New Government tech deals boost the business of cancer detection Page summary: New UK-created therapies for cancer will be trialled in the UK – furthering the nation’s life sciences industry as one of the great drivers of economic growth. Change made: First published. Time updated: 12:01am, 6 October 2024 Engineering Biology Sandbox Fund: successful projects Page summary: This fund supports…
Ben Kemp
October 15, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Brexit Updates (WC 13 Oct)

Safety and security requirements on imports and exports Page summary: Find out about safety and security requirements that apply to goods entering and exiting the UK. Change made: The waiver for import requirements for goods from the EU (and other territories that did not have requirements before 1 January 2021) has been extended until 31 January 2025. Time updated: 9:06am,…
Ben Kemp
October 15, 2024
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Stay Compliant with New IVD Regulations

Wednesday, Oct,16th , 2024 | 9:00 AM – 9:45 AM (Austin Texas, U.S.) Join Heather Crawford from the Emergo by UL’s team, live on Oct. 16, 2024 from 9-9:45 a.m. CST as she discusses Regulation (EU) 2024/1860. What has changed with the adoption of Regulation (EU) 2024/1860, and how can you determine whether you are eligible for the extension under…
Ben Kemp
October 15, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

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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