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Regulatory Affairs Newsletter Archive

European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Regulation (EU) 2017/746 – mdc medical device certification GmbH (NB 483)

Dear Members, EU NANDO Database updated for Regulation (EU) 2017/746 (EUROPA – European Commission – Growth – Regulatory policy - SMCS ), Regarding the entry for - mdc medical device certification GmbH (NB 483). Total count of available Notified Bodies remains at 18, so this looks to be a change in scope of designation. View article...
Ben Kemp
July 30, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

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

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
ConsultationsConsultations ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Your chance to shape the UK’s connected future in new SEPs consultation

Your chance to shape the UK's connected future in new SEPs consultation The IPO has launched a consultation on Standard Essential Patents (SEPs) to boost UK innovation and help businesses navigate the complex world of connected technologies. The consultation, which runs until 7 October 2025, represents a critical step towards creating a more transparent and efficient SEPs ecosystem that works…
Ben Kemp
July 30, 2025
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 21 July)

AI Airlock: the regulatory sandbox for AIaMD Page summary: A proactive, collaborative, agile and the first of its kind approach to identifying and addressing the challenges faced by AI as a Medical Device (AIaMD). Change made: Update to reflect that the pilot phase of the AI Airlock is complete, and that applications for phase 2 have now closed Time updated:…
Ben Kemp
July 30, 2025
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

CTDA (Coronavirus Test Device Approvals) Update

The MHRA recently announced that the current CTDA (Coronavirus Test Device Approvals) process for approval of SARS-CoV-2 tests is intended to be repealed with the introduction of the pre-market statutory instrument. Once Parliament agrees the statutory instrument, the MHRA have confirmed that the CTDA regulations will no longer apply from when the statutory instrument is made into legislation. They anticipate this…
Ben Kemp
July 29, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Commission Implementing Decision (EU) 2025/1324 setting up an expert panel for paediatrics and rare diseases

Please be advised that two new EU expert groups for medical devices including IVDs are to be established for Paediatrics and for Rare diseases. These will be established and organised by EMA. Interesting to see where Rare diseases and Paediatrics cross over as most rare diseases are detected, and have most opportunity to be impacted in paediatrics. MedTech Europe are…
Ben Kemp
July 10, 2025
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