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Regulatory Affairs Newsletter Archive

MDCG 2023-3 rev.2 – Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 under Regulation (EU) 2017/746 – January 2025 European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

MDCG 2023-3 rev.2 – Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 under Regulation (EU) 2017/746 – January 2025

MDCG 2023-3 rev.2 - Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 under Regulation (EU) 2017/746 - January 2025
Ben Kemp
January 17, 2025
MDCG 2022-3 rev.1 – Verification of manufactured class D IVDs by notified bodies (December 2024) European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

MDCG 2022-3 rev.1 – Verification of manufactured class D IVDs by notified bodies (December 2024)

MDCG have update their guidance MDCG 2022-3 rev.1 - Verification of manufactured class D IVDs by notified bodies (December 2024). Find out more here.
Ben Kemp
January 16, 2025
Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing): SOR/2024-238 Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

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
UPDATED – MDCG 2023-3 Q&A on vigilance terms and concepts European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

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
FDA Guidance – updates FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

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
FDA Consensus standards updated FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

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
MHRA Release Post-Market Surveillance Guidance Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

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
Biomedical Alliance in Europe publish policy recommendations on MDR and IVDR Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveMembership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

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