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Other Updates Regulatory Affairs Newsletter

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A new EFLM scientific paper has been published!

Is this test fit-for-purpose? Principles and a checklist for evaluating the clinical performance of a test in the new era of in vitro diagnostic (IVD) regulation Lord S J, Horvath R, Sandberg S, Monaghan P J, Cobbaert C M, Reim M, Tolios A, Mueller R, Bossuyton P M, on behalf of the EFLM Working Group on Test Evaluation Critical Reviews in Clinical…
Ben Kemp
February 21, 2025
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WHO Pre-Qualification meeting – 2024 Joint UNICEF/UNFPA/WHO Meeting with manufacturers and suppli

An update from WHO meeting regarding the WHO Pre-Qualification process (for blood glucose meters, STI kits and HbA1c for diabetes) and which devices are in scope. Plus updates to the WHO Essential IVD listings. This is a useful reference for UK exporters looking to place qualifying IVDs into Low and Middle Income Countries. 2024 Joint UNICEF-UNFPA-WHO Meeting with Manufacturers and…
Ben Kemp
February 3, 2025
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CLSI C34 | Sweat Testing: Specimen Collection and Quantitative Chloride Analysis

Newly Released Screening & Collection Guidance   CLSI C34 | Sweat Testing: Specimen Collection and Quantitative Chloride Analysis Date of Publication: 8 November 2024 Price: $180 for PDF CLSI C34 describes methods for all aspects of sweat testing, including collection and analysis, results evaluation and reporting, and quality control. You can purchase it here.
Ben Kemp
November 14, 2024
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Latest Blog: Creating a Circular Eco-System for Medical Devices: Single-Use vs Reuse

This is the latest blog in the Creating a Circular Eco-System for Medical Device series that aims to highlight different aspects and challenges of a circular economy in the healthcare and medical device industries. It addresses the principle of reuse and the struggle with choosing single-use or reusable devices, focusing on four (of many) areas that a manufacturer must consider.…
Ben Kemp
November 14, 2024
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Share your views on UKRI: participate in the stakeholder survey

UKRI are seeking feedback on perceptions of the organisation. The survey should take no more than 15 minutes to complete, and your responses will help UKRI to address issues, tailor their activities and measure their progress as an organisation over the coming years. Take the survey here.
Ben Kemp
November 14, 2024
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