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Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing): SOR/2024-238

Amendments have been made to the Food and Drug Regulations and Medical Devices Regulations that advance Health Canada’s modernization agenda by making Canada’s science-based regulatory system more agile and internationally aligned. Find out more here.
Ben Kemp
January 16, 2025
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UPDATED – MDCG 2023-3 Q&A on vigilance terms and concepts

MDCG have update Guidance MDCG 2023-3 Q&A on vigilance terms and concepts to Revision 2. There have been several editorial changes made to footnote 8 (adapted to gradual roll-out of Eudamed), Q21 (changed reference to ‘Eudamed Postmarket surveillance and Vigilance module (VGL module)’) and Footnote 34 (timeline for FSN clarified). You can find the updated document via the link: https://health.ec.europa.eu/document/download/af1433fd-ed64-4c53-abc7-612a7f16f976_en?filename=mdcg_2023-3_en.pdf…
Ben Kemp
January 16, 2025
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FDA Guidance – updates

Please find below the recently published Guidance and draft guidance documents: Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act | FDA Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers | FDA Global Unique Device Identification Database…
Ben Kemp
January 16, 2025
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FDA Consensus standards updated

Please find the updated FDA Consensus standards: Recognized Consensus Standards: Medical Devices See this list edited to remove obvious non IVD related standards, and new entries highlighted in yellow. Remember that you can check the specifics of the degree of recognition by using the links on the righthand side of the FDA web page.
Ben Kemp
January 16, 2025
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MHRA Release Post-Market Surveillance Guidance

The MHRA have released their guidance on new GB PMS requirements, introduced with the new PMS Statutory Instrument.  The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 amends the UK Medical Device Regulations 2002. The MHRA recommends members to start using the guidance immediately, to ensure you are prepared for when the new PMS requirements become mandatory from…
Ben Kemp
January 15, 2025
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Biomedical Alliance in Europe publish policy recommendations on MDR and IVDR

The BioMed Alliance has released two policy documents which include recommendations from healthcare professionals to address persisting challenges in the implementation of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). While these regulations aim to enhance the safety and transparency of medical devices and diagnostics across Europe, they believe there are certain shortcomings that must be…
Ben Kemp
January 14, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Border Target Operating Model – getting it right at the border 19/12/24

Border Services update from HMRC – Goods Vehicle Movement Service (GMVS)   Following weather damage caused by Storm Darragh, Holyhead Port has needed to temporarily close for urgent repair works and is not expected to open until at least 15 January 2025.   HMRC continues to work with Holyhead Port, the affected maritime carriers and with Border Force to monitor…
Ben Kemp
January 9, 2025
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The first six EU reference laboratories for public health are now operational

The first six EU reference laboratories for public health are now operational Since 1 January 2025, the first six EU reference laboratories (EURLs) for public health have been operational and will now carry out activities for the next seven years. The EURLs, which bring together consortia of scientific expertise from across the EU, contribute to improving EU preparedness and ensuring…
Ben Kemp
January 9, 2025
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