The UK MHRA has today published its promised public consultation on indefinite recognition of CE marked medical devices for the Great Britain (GB) (England, Scotland, and Wales) market (Northern Ireland already accepts CE marked devices). The consultation invites views on the following proposals: Extending the current transitional arrangements for devices that comply with the Medical…
The US Food and Drug Administration (FDA) has reissued a final guidance on quality system management considerations for medical device cybersecurity following the agency’s transition from the Quality System Regulation (QSR) to the Quality System Management Regulation (QMSR, 21 CFR 820). The new guidance replaces references to the QSR with references to the QMSR and,…
For the second time in a month, the US Food and Drug Administration (FDA) has updated its guidance on Clinical Decsion Support (CDS) Software. The Agency published its first final guidance on the subject in 2022, but then issued an updated version on 6 January 2026, which was superseded by a further version on 29…
In Commission Implementing Decision (EU) 2026/197 of 28 January 2026 , the Commission has announced that a further 6 standards have been harmonised under the Medical Device Regulation (MDR, 2017/745), as follows:
In Commission Implementing Decision (EU) 2026/193, the Commission has announced that a further 12 standards have been harmonised under the Medical Device Regulation (MDR, 2017/745), as follows:
To coincide with mandatory use of the Agency’s Quality Management System Regulation (QMSR, 21 CFR 820) requirements, FDA has also replaced its ‘Quality System Inspection Technique’ (QSIT) guidance for Inspectors with a ‘Compliance Program Manual: Inspection of Medical Device Manufacturers’, with effect from 2 February 2026, explaining that the program has been updated to align…
The US Food and Drug Administration (FDA) has published the final version of its guidance document titled ‘Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program’, superseding the draft published in June 2018.
As in the draft, the guidance provides advice to medical device manufacturers on the following types of …
The International Standardisation Organisation (ISO) has now published a revised version of this cornerstone standard for biological evaluation of medical devices, which has been completely reorganized to align with the ISO 14971 on risk management for medical devices. The new standard, ISO 10993-1:2025, ‘Biological evaluation of medical devices – Part 1: Requirements and general principles…
The EU Medical Device Coordination Group (MDCG) has released several new guidance documents in recent weeks, including: MDCG 2025-7 Rev. 1: Timelines of the implementation of ‘Master UDI-DI’ to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles MDCG 2025-8: Guidance on the implementation of the Master UDI-DI solution for spectacle frames, spectacle…
Donawa Lifescience President, Maria E. Donawa, M.D., has authored a ‘Regulatory Recap’ article on LinkedIn titled ‘Proposed MDR Amendments and Clinical Data Requirements.’ Following Dr. Donawa’s February 2025 LinkedIn article on the current MDR’s clinical data requirements, the Commission’s December 2025 proposed MDR amendments have now been reviewed with particular attention to clinical data and…
