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Ben Kemp

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Join Task and Finish Group to rewrite BIVDA’s Code of Ethical Conduct

BIVDA are updating our Code of Ethical Conduct to ensure it reflects our position in 2025 and our commitments to MedTech Europe. Members have individually expressed an interest in assisting, therefore we are assembling a small group of volunteers to work on this document as a task and finish group. It will cover aspects impacted by product regulation and compliance,…
Ben Kemp
August 26, 2025
Membership NewsMembership News Archive

BIVDA welcomes new member Mantara Health Ltd

  BIVDA are pleased to welcome Mantara Health as new members! Founded in 2020, Mantara Health Ltd has developed the first MHRA-registered, UKCA/CE accredited pharmacogenomic panel test for commercial use in the UK, validated and using the same algorithm as the Lancet-published Prepare study from February 2023. Over the last couple of years, Mantara Health has won the 2023 Start…
Ben Kemp
August 25, 2025
FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

FDA New Classifications published

Dear members, Neil Plumridge spotted the following Politico article regarding updates to FDA classifications: Devices, diagnostics and digital health CLASSIFICATION ORDER BONANZA: The FDA’s Center for Devices and Radiological Health today issued nine medical device classification orders, primarily (eight out of the nine) for diagnostic products. The issuance of these orders is the last step in formally codifying a new…
Ben Kemp
August 22, 2025
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

For input by 29/8: ECHA RAC Talc Opinion/Classification Carcinogenic 1B

Dear members, please see below call for feedback regarding the classification of ‘Talc’ as Class 1B Carcinogen. The focus is on Medial devices. I’m not aware of any IVD devices that utilise ‘Talc’, but if your impacted please contact me via regulatory@bivda.org.uk We are writing to inform you that recently, the European Chemical Agency’s (ECHA) Risk Assessment Committee (RAC) published…
Ben Kemp
August 22, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

APHA – Border Trade Newsletter – getting it right at the border 14 08 25

Getting it right at the border  This newsletter from the Animal and Plant Health Agency (APHA) covers the latest operational updates on requirements and border controls for importing live animals, germinal products, products of animal origin and animal by-products into Great Britain. In this newsletter: IPAFFS Scheduled Update - 14 August Lumpy skin disease: import of animal by-products from France,…
Ben Kemp
August 21, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

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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