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Health Technology Assessment – Commission adopts rules for joint scientific consultations on medical devices and in vitro diagnostic medical devices

Health Technology Assessment - Commission adopts rules for joint scientific consultations on medical devices and in vitro diagnostic medical devices Today, the European Commission adopted an implementing regulation establishing the rules for joint scientific consultations on medical devices and in vitro diagnostic medical devices, under the Health Technology Assessment (HTA) Regulation. The implementing act provides detailed procedural rules for the…
Ben Kemp
February 3, 2025
Other Updates Regulatory Affairs NewsletterOther Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

WHO Pre-Qualification meeting – 2024 Joint UNICEF/UNFPA/WHO Meeting with manufacturers and suppli

An update from WHO meeting regarding the WHO Pre-Qualification process (for blood glucose meters, STI kits and HbA1c for diabetes) and which devices are in scope. Plus updates to the WHO Essential IVD listings. This is a useful reference for UK exporters looking to place qualifying IVDs into Low and Middle Income Countries. 2024 Joint UNICEF-UNFPA-WHO Meeting with Manufacturers and…
Ben Kemp
February 3, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Brexit Updates (WC 27 Jan)

  Notices under The Customs Transit Procedures (EU Exit) Regulations 2018  Page summary: Notices under The Customs (Transitional Arrangements) (EU Exit) Regulations 2020 which have force of law under Customs Regulations. Change made: Notices made under the Taxation (Cross-border Trade) Act 2018 has been updated to show changes due to the implementation of NCTS5. Time updated: 9:00am, 20 January 2025…
Ben Kemp
February 3, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT Updates (WC 27 Jan)

Archaic tech sees public sector miss £45 billion annual savings Page summary: Public sector workers are being held back by archaic technology according to a new report set to be published on Tuesday. Change made: First published. Time updated: 7:00am, 19 January 2025 Shake up of tech and AI usage across NHS and other public services to deliver plan for…
Ben Kemp
February 3, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT Updates (WC 27 Jan)

UK firms boosted by new qualifications agreement with Switzerland Page summary: UK-qualified professionals to find it easier to work in Switzerland, as new permanent agreement ensures professional qualifications can be recognised. Change made: Profession amendment – anaesthetists changed to anaesthesia associates Time updated: 11:33am, 20 January 2025   Apply for a standard individual export licence (SIEL) updated Page summary: Use…
Ben Kemp
February 3, 2025
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