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Industry Newsletters Regulatory Affairs Newsletter Archive

Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

RCPATH – Self-sampling at the point-of-care – enhancing access, improving care

Self-sampling at the point-of-care – enhancing access, improving care As the UK regulator for medical devices, the MHRA ensures that self-sampling devices are safe, effective, and properly registered before they can be used. This article, which the MHRA have co-authored with the Royal College of Pathologists, sets out clear guidance on regulation, including device marking (UKCA/CE), transport requirements, and the…
Ben Kemp
September 8, 2025
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TGA – Use of market authorisation evidence from comparable overseas regulatory and assessment bodies for medical devices (including IVDs)

We are resharing this update from earlier in the year: TGA - Use of market authorisation evidence from comparable overseas regulatory and assessment bodies for medical devices (including IVDs) Use of market authorisation evidence from comparable overseas regulators and assessment bodies for medical devices (including IVDs) | Therapeutic Goods Administration (TGA) Mentions CE to the directives and the regulation for…
Ben Kemp
August 28, 2025
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BS EN IEC 82474-1:2025

Dear members, please be advised that the following standard regarding full material declarations has been published. Derived from the existing IEC standard  BS EN IEC 62474:2019+A1:2021 | 31 Jan 2021 | BSI Knowledge for full material declarations for products of and for the electrotechnical industry. BS EN IEC 82474-1:2025 | 31 Jul 2025 | BSI Knowledge The standard provides a…
Ben Kemp
August 28, 2025
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EN IEC 61326-2-6:2025 Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical electrical equipment

Dear members, CENELEC have adopted EN IEC 61326-2-6:2025 Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical electrical equipment (publication date=2025-08-22) as a European standard. This has not been harmonised to the IVDR at this time. View article... Adoption as a British Standard is currently proceeding British…
Ben Kemp
August 28, 2025
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Just Released: CLSI NBS11: Guidance for Newborn Screening of Congenital Adrenal Hyperplasia

The new CLSI NBS11 - Newborn Screening for Congenital Adrenal Hyperplasia, provides laboratories with clear recommendations for using dried blood spot specimens to perform newborn screening (NBS) for congenital adrenal hyperplasia (CAH). This newly released standard covers the full testing process, including preanalytical, analytical, and postanalytical phases, as well as both short-term and long-term follow-up considerations.  
Ben Kemp
August 21, 2025
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ISO 15223-1 and the Authorized Representative Symbol

A significant change with broad implications ISO 15223-1 is a crucial standard for medical device manufacturers, providing symbols to convey information about devices without relying on text. This minimizes translation needs, frees up label space, and meets various regulatory requirements. On March 5, 2025, ISO 15223-1:2021/Amd 1:2025 introduced a significant change to the Authorized Representative symbol, altering the part of…
Ben Kemp
August 4, 2025
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Historic Milestones: UK and Singapore join HealthAI

Historic Milestones: UK and Singapore join HealthAI Both Governments Building Global Momentum for Responsible AI in Health We are witnessing the emergence of a new era in healthcare AI governance, one where national boundaries give way to shared responsibility and multilateral collaboration. The recent expansion of our HealthAI Global Regulatory Network (GRN) marks not just institutional growth, but a fundamental…
Ben Kemp
July 30, 2025
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Biocides: EU active substance non-approval decisions and expiry date

Biocidal products must be phased off the NI market. Following evaluation/withdrawal of support under the EU Biocidal Products Regulation (EU BPR), a decision has been taken not to approve the following active substance/product type combinations. This will affect NI: 1,2-benzisothiazol-3(2H) - one (BIT) (CAS 2634-33-5 EC 220-120-9) in product type 2 Pyrithione zinc (CAS 13463-41-7 EC 236-671-3) in product types…
Ben Kemp
July 30, 2025
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New! Ensure Excellence in Molecular Testing with CLSI MM14

As molecular methods become essential in clinical diagnostics, the need for high-quality proficiency testing has never been greater. The brand new CLSI MM14—Design of Molecular Proficiency Testing/External Quality Assessment gives you the comprehensive guidance you need to establish or evaluate PT/EQA programs with confidence.   This essential resource covers: Creating reliable, high-quality PT/EQA schemes for molecular methods Best practices for…
Ben Kemp
July 30, 2025
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