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 KempJanuary 16, 2025
Finished IVD’s are exempt from Biocides regulation however intermediates and raw materials are not exempt. PT 2 and 3 are regarding disinfectants, and PT 6 is regarding preservatives used in products. PT 2 & 3 can have an indirect impact on IVD’s by impacting the available disinfectants available for use to disinfect IVD’s. Companies placing products on the market which…
Ben KempJanuary 16, 2025
Please find below the recently published Guidance and draft guidance documents: Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act | FDA Communications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 KempJanuary 16, 2025
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 KempJanuary 16, 2025
The Department of Science, Innovation and Technology has launched a Technology Adoption Review designed to identify the barriers businesses face when adopting both established and novel technologies. Policy recommendations will be formed to establish how government and businesses can work together to remove obstacles. The review’s recommendations will also directly inform the development of the forthcoming Industrial Strategy and sector…
Ben KempJanuary 15, 2025
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 KempJanuary 15, 2025
Dementia blood test diagnosis trial gets underway A trial to identify fast and accurate blood tests that can diagnose dementia comes at an "exciting" time in the treatment of the disease, according to a leading scientist. More than 3,800 people from 28 NHS memory clinics across the UK are being invited to sign up to the five-year Read-Out study, external…
Ben KempJanuary 14, 2025
This week, the Prime Minister attempted to relaunch his Government in the new year by unveiling a pro-growth plan to turbocharge AI in the UK. The plan sets out a range of measures to help the UK develop and adopt artificial intelligence in many areas to, in Sir Keir's own words, 'mainline AI in the veins' of the nation. Among…
Ben KempJanuary 14, 2025