Official updates
Selected regulations, rulings and guidance from official authorities. Dates are publication dates, with effective dates shown separately where relevant.
Curated collection · Sources checked · Not an exhaustive or live news feed
9 of 9 updates
Daily research and device updatesUnited Kingdom
Policy announcement
The government confirmed its decision to continue recognising CE-marked medical devices and IVDs in Great Britain alongside UKCA. This is an announced policy decision; the release says engagement will continue as the arrangements are implemented. It should not be read as the detailed replacement for existing transition rules.
Official source: MHRAAustralia
Regulation
The TGA's June update confirms that UDI requirements become mandatory for Class III and Class IIb medical devices from July 1, 2026. Lower classes are phased in later; the update also describes consent-to-supply arrangements for sponsors unable to comply.
Effective:
Official source: TGAUnited States
Guidance
The February 2026 final guidance supersedes the June 27, 2025 edition, with revisions aligning it to the QMSR amendments to 21 CFR Part 820. It covers cybersecurity design, labelling and premarket documentation, including section 524B considerations for cyber devices. Guidance recommendations are distinct from the statute's binding requirements.
Official source: FDAUnited States
Guidance
The updated PCCP guidance, originally issued on December 4, 2024, recommends describing planned modifications, the methods to develop and validate them, and their impact assessment. FDA reviews the PCCP with the marketing submission; changes within an authorised plan can avoid an additional submission where statutory conditions are met.
Official source: FDAUnited Kingdom
Regulation
The MHRA announced implementation of the strengthened PMS rules. Its scope guidance applies them to individual devices placed on the market or put into service in Great Britain from June 16, 2025, including CE- and UKCA-marked devices, subject to exclusions. Earlier individual devices retain prior obligations; Northern Ireland follows EU rules.
Effective:
Official source: MHRAUnited States
Ruling
The FDA reports that a federal district court vacated its May 2024 LDT final rule on March 31, 2025. The FDA subsequently issued a September 19, 2025 final rule restoring the previous regulatory wording. The 2024 rule is therefore historical, not an operative phase-in requirement.
Official source: FDA (official account of the court ruling)United States
Policy announcement
CMS outlined a voluntary Medicare coverage pathway for certain FDA-designated Breakthrough Devices, using national coverage determinations and evidence development. FDA market authorisation is not automatic Medicare coverage; the pathway addresses separate coverage and evidence questions.
Official source: CMSEuropean Union
Regulation
Regulation (EU) 2024/1860 amends MDR and IVDR provisions on the gradual rollout of EUDAMED, notification of supply interruptions or discontinuation, and transitional provisions for certain IVDs. Extensions depend on device-specific conditions and do not remove the need to meet the applicable transition requirements.
Official source: European Union / EUR-LexUnited States
Regulation
The QMSR final rule amends FDA device quality-system requirements and incorporates ISO 13485:2016 by reference, with additional FDA-specific provisions. The rule's effective date is February 2, 2026, distinct from its February 2024 publication.
Effective:
Official source: FDA